Medicines and other therapeutic goods must comply with applicable standards to be supplied in Australia.
Under the Therapeutic Goods Act 1989 prior consent must be given under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard. The Secretary can impose conditions on the consent under section 15 of the Act.
The records below include information about these decisions, and any subsequent review of such decisions. All records below which relate to a single consent decision will have the same consent number.
Information about decisions made before 29 January 2016 are on the Federal Register of Legislation website.
For guidance on applying for consent see Consent to import, supply or export therapeutic goods that do not comply with standards - information for industry
In July 2020, TGA created a special consent process for prescription medicine manufacturers experiencing difficulties in introducing new TGO91 labels into their manufacturing process due to COVID-19. These decisions are displayed in a separate database: Database of consents for prescription medicines that do not comply with TGO 91 labelling due to COVID-19.
| Product name | Sponsor name | ARTG | Batches | Consent no. | Consent duration | Consent start | Standard | Non-compliance with standard | Conditions imposed | For Import, Supply, &/or Export | Therapeutic product type |
|---|---|---|---|---|---|---|---|---|---|---|---|
| PHARMACY CHOICE IBUPROFEN 200mg soft gelatin capsule blister pack (20, 40 and 100 tablets pack) | Symbion Pty Ltd | 192235 | VG5002 | CON-31 | The consent is effective from 13 January 2016 until 12 June 2016. | 13/01/2016 | Subclause 3(2)(g) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The medicine labels do not include all of the advisory statements that are required by schedule 2 of the Medicines Advisory Statements Specifications 2014 from 12 December 2015. | The labels to which this consent applies are those previously approved for these products, copies of which were provided with the request letter of 18 December 2015. | Supply | Over-the-counter medicines |
| CHEMMART PHARMACY IBUPROFEN 200mg soft gelatin capsule blister pack (20, 40 and 100 tablets pack) | Symbion Pty Ltd | 192234 | VA4005, VA5001 | CON-31 | The consent is effective from 13 January 2016 until 12 June 2016. | 13/01/2016 | Subclause 3(2)(g) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The medicine labels do not include all of the advisory statements that are required by schedule 2 of the Medicines Advisory Statements Specifications 2014 from 12 December 2015. | The labels to which this consent applies are those previously approved for these products, copies of which were provided with the request letter of 18 December 2015. | Supply | Over-the-counter medicines |
| OCTAPLAS LG solvent/detergent human plasma solution for injection bag 200 mL | Octapharma Australia Pty Ltd | 96613 | CON-34 | The consent is effective from 1 Feburary 2016 until such time as the requirement for Hepatitis A antibody levels in the monograph ‘Human Plasma pooled and treated for virus inactivation’ (Ph. Eur. monograph 1646) are changed to levels ≤0.3 IU/mL, and is legally binding in Australia. | 1/02/2016 | European Pharmacopoeia monograph 1646 ‘Human Plasma pooled and treated for virus inactivation’. | The product does not meet the anti-Hepatitis A virus (HAV) antibody limit of ≥ 1 IU/ mL. | The Hepatitis A antibody levels of the product must be ≥ 0.3 IU/mL. The sensitivity of the Hepatitis A virus nucleic acid test used on the manufacturing pool is ≤13 IU/mL. | Import and supply | Prescription medicines | |
| rizatriptan (as benzoate) (RIZATRIPTAN WAFERS) 10 mg wafer blister pack | Merck Sharp Dohme (Australia Pty) Ltd | 225969 | CON-36 | The consent is effective from from the 9 February 2016 until 31 December 2017. | 9/02/2016 | Paragraph 3(12)(a) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | The blister foil label does not include either the name or the registered trade-mark of the sponsor and the product name of the medicine. | The blister foil label for use with the product is that provided in the application. | Import and supply | Prescription medicines | |
| PHARMACY ACTION PARACETAMOL PLUS CODEINE 500 mg/10 mg tablets blister pack | Generic Health Pty Ltd | 200691 | 450684 | CON-33 | The consent is effective from the 10 February 2016 to batch number 450684 until 30 September 2016. | 10/02/2016 | Paragraph 3(2)(g) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The product labels do not include all of the new warning statements required by the legislative instrument made by the Minister under subsection 3(5A) of the Act ('RASML No 2'), from 12 December 2015. | The labels to which this consent applies are those previously approved by the Therapeutic Goods Administration for these products, copies of which were provided with the request. | Import and supply | Over-the-counter medicines |
| meningococcal (Groups A, C, W-135 and Y) (MENVEO) oligosaccharide CRM197 conjugate vaccine | GlaxoSmithKline Australian Pty Ltd | 192696 | CON-39 | The consent is effective from the 11 February 2016 until 30 November 2016. | 11/02/2016 | Paragraph 3(2)(l) of Therapeutic Goods Order Number 69, General requirements for labels for medicines. | The products will be supplied in labels containing the name and address of the previous sponsor (Novartis Vaccines and Diagnostics Pty Ltd), rather than the current sponsor (GlaxoSmithKline Australia Pty Ltd). | The labels to which this consent applies are those previously approved for the former sponsor Novartis Vaccines and Diagnostics Pty Ltd, Arrangements are in place with the former sponsor (Novartis Vaccines and Diagnostics Pty Ltd) for the prompt referral of any queries or complaints concerning the products to the current sponsor GlaxoSmithKline Australia Pty Ltd. | Import and supply | Prescription medicines | |
| meningococcal (Groups A, C, W-135 and Y) (MENVEO) oligosaccharide CRM197 conjugate vaccine | GlaxoSmithKline Australian Pty Ltd | 158477 | CON-39 | The consent is effective from the 11 February 2016 until 30 November 2016. | 11/02/2016 | Paragraph 3(2)(l) of Therapeutic Goods Order Number 69, General requirements for labels for medicines. | The products will be supplied in labels containing the name and address of the previous sponsor (Novartis Vaccines and Diagnostics Pty Ltd), rather than the current sponsor (GlaxoSmithKline Australia Pty Ltd). | The labels to which this consent applies are those previously approved for the former sponsor Novartis Vaccines and Diagnostics Pty Ltd, Arrangements are in place with the former sponsor (Novartis Vaccines and Diagnostics Pty Ltd) for the prompt referral of any queries or complaints concerning the products to the current sponsor GlaxoSmithKline Australia Pty Ltd. | Import and supply | Prescription medicines | |
| pertussis vaccine – (ADACEL POLIO) acellular diphtheria and tetanus toxoids (adsorbed) combined with inactivated poliovirus 1, 2 and 3 (vero cell) 0.5 mL injection syringe | Sanofi-Aventis Australia Pty Ltd | 106576 | Batch L0376-4, quantity 5,000, Expiry 30 June 2017 | CON-38 | The consent is effective from 12 February 2016 until 30 June 2017. | 12/02/2016 | Paragraph 3(2)(c) of the Therapeutic Goods Order Number 69 – General requirements for labels for medicines. | The product will be supplied with syringe labelled with Standard International label, rather than the Australian syringe label. | A 'Dear Healthcare Provider' letter identical to that provided to the Therapeutic Goods Administration on 8 February 2016 (TGA reference R16/89758) will be supplied with the affected batch, and this batch of ADACEL POLIO is exactly the same as the other batches currently available in Australia, with the exception of the syringe label. | Import and supply | Prescription medicines |
| pramipexole hydrochloride monohydrate (PRAMIPEXOLE XR GP) 4.5 mg modified release tablet blister pack | Alphapharm Pty Ltd | 225617 | CON-37 | The consent is effective from the 15 February 2016 until 14 February 2017. | 15/02/2016 | Paragraph 3(13)(a) of the Therapeutic Goods Order No. 69, General requirements for labels for medicines. | On the blister foil labels of the products, the expiry date precedes the expiry date prefix ("Exp:"). | The blister foil label to be used for the products is the same as the sample blister foil label for the 3mg Pramipexole XR GP tablet submitted with your application. For indicating the location of the expiry date, the foil label includes an arrow printed immediately to the left of the expiry date abbreviation "EXP:" while the location of the batch number is indicated by an arrow printed immediately to the right of the batch number abbreviation"Lot:". During the 12 months exemption period, the company will take relevant corrective actions to enable the foil labels to be changed to ensure compliance with TGO No. 69. In this regard, in order to avoid confusion, the company should ensure that the batch number and expiry date prefixes printed on the carton and blister foil labels are the same. | Import and supply | Prescription medicines | |
| pramipexole hydrochloride monohydrate (PRAMIPEXOLE XR GP) 3.75 mg modified release tablet blister pack | Alphapharm Pty Ltd | 225599 | CON-37 | The consent is effective from the 15 February 2016 until 14 February 2017. | 15/02/2016 | Paragraph 3(13)(a) of the Therapeutic Goods Order No. 69, General requirements for labels for medicines. | On the blister foil labels of the products, the expiry date precedes the expiry date prefix ("Exp:"). | The blister foil label to be used for the products is the same as the sample blister foil label for the 3mg Pramipexole XR GP tablet submitted with your application. For indicating the location of the expiry date, the foil label includes an arrow printed immediately to the left of the expiry date abbreviation "EXP:" while the location of the batch number is indicated by an arrow printed immediately to the right of the batch number abbreviation"Lot:". During the 12 months exemption period, the company will take relevant corrective actions to enable the foil labels to be changed to ensure compliance with TGO No. 69. In this regard, in order to avoid confusion, the company should ensure that the batch number and expiry date prefixes printed on the carton and blister foil labels are the same. | Import and supply | Prescription medicines | |
| pramipexole hydrochloride monohydrate (PRAMIPEXOLE XR GP) 3 mg modified release tablet blister pack | Alphapharm Pty Ltd | 225631 | CON-37 | The consent is effective from the 15 February 2016 until 14 February 2017. | 15/02/2016 | Paragraph 3(13)(a) of the Therapeutic Goods Order No. 69, General requirements for labels for medicines. | On the blister foil labels of the products, the expiry date precedes the expiry date prefix ("Exp:"). | The blister foil label to be used for the products is the same as the sample blister foil label for the 3mg Pramipexole XR GP tablet submitted with your application. For indicating the location of the expiry date, the foil label includes an arrow printed immediately to the left of the expiry date abbreviation "EXP:" while the location of the batch number is indicated by an arrow printed immediately to the right of the batch number abbreviation"Lot:". During the 12 months exemption period, the company will take relevant corrective actions to enable the foil labels to be changed to ensure compliance with TGO No. 69. In this regard, in order to avoid confusion, the company should ensure that the batch number and expiry date prefixes printed on the carton and blister foil labels are the same. | Import and supply | Prescription medicines | |
| pramipexole hydrochloride monohydrate (PRAMIPEXOLE XR GP) 2.25 mg modified release tablet blister pack | Alphapharm Pty Ltd | 225588 | CON-37 | The consent is effective from the 15 February 2016 until 14 February 2017. | 15/02/2016 | Paragraph 3(13)(a) of the Therapeutic Goods Order No. 69, General requirements for labels for medicines. | On the blister foil labels of the products, the expiry date precedes the expiry date prefix ("Exp:"). | The blister foil label to be used for the products is the same as the sample blister foil label for the 3mg Pramipexole XR GP tablet submitted with your application. For indicating the location of the expiry date, the foil label includes an arrow printed immediately to the left of the expiry date abbreviation "EXP:" while the location of the batch number is indicated by an arrow printed immediately to the right of the batch number abbreviation"Lot:". During the 12 months exemption period, the company will take relevant corrective actions to enable the foil labels to be changed to ensure compliance with TGO No. 69. In this regard, in order to avoid confusion, the company should ensure that the batch number and expiry date prefixes printed on the carton and blister foil labels are the same. | Import and supply | Prescription medicines | |
| pramipexole hydrochloride monohydrate (PRAMIPEXOLE XR GP) 1.5 mg modified release tablet blister pack | Alphapharm Pty Ltd | 225600 | CON-37 | The consent is effective from the 15 February 2016 until 14 February 2017. | 15/02/2016 | Paragraph 3(13)(a) of the Therapeutic Goods Order No. 69, General requirements for labels for medicines. | On the blister foil labels of the products, the expiry date precedes the expiry date prefix ("Exp:"). | The blister foil label to be used for the products is the same as the sample blister foil label for the 3mg Pramipexole XR GP tablet submitted with your application. For indicating the location of the expiry date, the foil label includes an arrow printed immediately to the left of the expiry date abbreviation "EXP:" while the location of the batch number is indicated by an arrow printed immediately to the right of the batch number abbreviation"Lot:". During the 12 months exemption period, the company will take relevant corrective actions to enable the foil labels to be changed to ensure compliance with TGO No. 69. In this regard, in order to avoid confusion, the company should ensure that the batch number and expiry date prefixes printed on the carton and blister foil labels are the same. | Import and supply | Prescription medicines | |
| pramipexole hydrochloride monohydrate (PRAMIPEXOLE XR GP) 0.75 mg modified release tablet blister pack | Alphapharm Pty Ltd | 225585 | CON-37 | The consent is effective from the 15 February 2016 until 14 February 2017. | 15/02/2016 | Paragraph 3(13)(a) of the Therapeutic Goods Order No. 69, General requirements for labels for medicines. | On the blister foil labels of the products, the expiry date precedes the expiry date prefix ("Exp:"). | The blister foil label to be used for the products is the same as the sample blister foil label for the 3mg Pramipexole XR GP tablet submitted with your application. For indicating the location of the expiry date, the foil label includes an arrow printed immediately to the left of the expiry date abbreviation "EXP:" while the location of the batch number is indicated by an arrow printed immediately to the right of the batch number abbreviation"Lot:". During the 12 months exemption period, the company will take relevant corrective actions to enable the foil labels to be changed to ensure compliance with TGO No. 69. In this regard, in order to avoid confusion, the company should ensure that the batch number and expiry date prefixes printed on the carton and blister foil labels are the same. | Import and supply | Prescription medicines | |
| pramipexole hydrochloride monohydrate (PRAMIPEXOLE XR GP) 0.375 mg modified release tablet blister pack | Alphapharm Pty Ltd | 225591 | CON-37 | The consent is effective from the 15 February 2016 until 14 February 2017. | 15/02/2016 | Paragraph 3(13)(a) of the Therapeutic Goods Order No. 69, General requirements for labels for medicines. | On the blister foil labels of the products, the expiry date precedes the expiry date prefix ("Exp:"). | The blister foil label to be used for the products is the same as the sample blister foil label for the 3mg Pramipexole XR GP tablet submitted with your application. For indicating the location of the expiry date, the foil label includes an arrow printed immediately to the left of the expiry date abbreviation "EXP:" while the location of the batch number is indicated by an arrow printed immediately to the right of the batch number abbreviation"Lot:". During the 12 months exemption period, the company will take relevant corrective actions to enable the foil labels to be changed to ensure compliance with TGO No. 69. In this regard, in order to avoid confusion, the company should ensure that the batch number and expiry date prefixes printed on the carton and blister foil labels are the same. | Import and supply | Prescription medicines | |
| epoetin lambda (rch) (NOVICRIT) 10,000 IU/1.0 mL solution for injection syringe | Sandoz Pty Ltd | 147842 | 1505120105, Qty 791, Expiry 01/2017 1506080059, Qty 2317, Expiry 01/2017 | CON-40 | The consent is effective from the 18 February 2016 until the 31 August 2016. | 18/02/2016 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69-General requirements for labels for medicines. | The packaging and labels will contain the former sponsor's (Novartis) name and phone contact details and to continue supply of existing stocks with the currently approved labels until 31 August 2016, following the transfer of sponsorship from Novartis to Sandoz. | A category 3 application to vary the labels to be compliant with paragraph 3(2)(I)of the Therapeutic Goods Order No. 69- General requirements for labels for medicines will be submitted to the Therapeutic Goods Administration for approval in February 2016. Sandoz Pty Ltd (the current sponsor) and Novartis Pharmaceuticals Australia Pty Ltd (the previous sponsor) have in place, for the period of this exemption, agreements and standard operating procedures (SOP) to cover the products, to ensure that any adverse events, products complaints or consumer enquiries reported to one party to the agreements are shared and directed to the most relevant party as applicable. For the non-marketed strengths 7000IU and 9000IU, the labels will be identical to the marketed strengths, except for the product strength. | Supply | Prescription medicines |
| epoetin lambda (rch) (NOVICRIT) 9,000 IU/0.9 mL solution for injection syringe | Sandoz Pty Ltd | 147838 | Currently not marketed | CON-40 | The consent is effective from the 18 February 2016 until the 31 August 2016. | 18/02/2016 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69-General requirements for labels for medicines. | The packaging and labels will contain the former sponsor's (Novartis) name and phone contact details and to continue supply of existing stocks with the currently approved labels until 31 August 2016, following the transfer of sponsorship from Novartis to Sandoz. | A category 3 application to vary the labels to be compliant with paragraph 3(2)(I)of the Therapeutic Goods Order No. 69- General requirements for labels for medicines will be submitted to the Therapeutic Goods Administration for approval in February 2016. Sandoz Pty Ltd (the current sponsor) and Novartis Pharmaceuticals Australia Pty Ltd (the previous sponsor) have in place, for the period of this exemption, agreements and standard operating procedures (SOP) to cover the products, to ensure that any adverse events, products complaints or consumer enquiries reported to one party to the agreements are shared and directed to the most relevant party as applicable. For the non-marketed strengths 7000IU and 9000IU, the labels will be identical to the marketed strengths, except for the product strength. | Supply | Prescription medicines |
| epoetin lambda (rch) (NOVICRIT) 8,000 IU/0.8 mL solution for injection syringe | Sandoz Pty Ltd | 147837 | 1505120107, Qty 683, Expiry 01/2017 1505120110, Qty 1320, Expiry 01/2017 | CON-40 | The consent is effective from the 18 February 2016 until the 31 August 2016. | 18/02/2016 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69-General requirements for labels for medicines. | The packaging and labels will contain the former sponsor's (Novartis) name and phone contact details and to continue supply of existing stocks with the currently approved labels until 31 August 2016, following the transfer of sponsorship from Novartis to Sandoz. | A category 3 application to vary the labels to be compliant with paragraph 3(2)(I)of the Therapeutic Goods Order No. 69- General requirements for labels for medicines will be submitted to the Therapeutic Goods Administration for approval in February 2016. Sandoz Pty Ltd (the current sponsor) and Novartis Pharmaceuticals Australia Pty Ltd (the previous sponsor) have in place, for the period of this exemption, agreements and standard operating procedures (SOP) to cover the products, to ensure that any adverse events, products complaints or consumer enquiries reported to one party to the agreements are shared and directed to the most relevant party as applicable. For the non-marketed strengths 7000IU and 9000IU, the labels will be identical to the marketed strengths, except for the product strength. | Supply | Prescription medicines |
| epoetin lambda (rch) (NOVICRIT) 7,000 IU/0.7 mL solution for injection syringe | Sandoz Pty Ltd | 147835 | Currently not marketed | CON-40 | The consent is effective from the 18 February 2016 until the 31 August 2016. | 18/02/2016 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69-General requirements for labels for medicines. | The packaging and labels will contain the former sponsor's (Novartis) name and phone contact details and to continue supply of existing stocks with the currently approved labels until 31 August 2016, following the transfer of sponsorship from Novartis to Sandoz. | A category 3 application to vary the labels to be compliant with paragraph 3(2)(I)of the Therapeutic Goods Order No. 69- General requirements for labels for medicines will be submitted to the Therapeutic Goods Administration for approval in February 2016. Sandoz Pty Ltd (the current sponsor) and Novartis Pharmaceuticals Australia Pty Ltd (the previous sponsor) have in place, for the period of this exemption, agreements and standard operating procedures (SOP) to cover the products, to ensure that any adverse events, products complaints or consumer enquiries reported to one party to the agreements are shared and directed to the most relevant party as applicable. For the non-marketed strengths 7000IU and 9000IU, the labels will be identical to the marketed strengths, except for the product strength. | Supply | Prescription medicines |
| epoetin lambda (rch) (NOVICRIT) 6,000 IU/0.6 mL solution for injection syringe | Sandoz Pty Ltd | 147844 | 1505120097, Qty 984, Expiry 01/2017 1508260096, Qty 1163, Expiry 03/2017 | CON-40 | The consent is effective from the 18 February 2016 until the 31 August 2016. | 18/02/2016 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69-General requirements for labels for medicines. | The packaging and labels will contain the former sponsor's (Novartis) name and phone contact details and to continue supply of existing stocks with the currently approved labels until 31 August 2016, following the transfer of sponsorship from Novartis to Sandoz. | A category 3 application to vary the labels to be compliant with paragraph 3(2)(I)of the Therapeutic Goods Order No. 69- General requirements for labels for medicines will be submitted to the Therapeutic Goods Administration for approval in February 2016. Sandoz Pty Ltd (the current sponsor) and Novartis Pharmaceuticals Australia Pty Ltd (the previous sponsor) have in place, for the period of this exemption, agreements and standard operating procedures (SOP) to cover the products, to ensure that any adverse events, products complaints or consumer enquiries reported to one party to the agreements are shared and directed to the most relevant party as applicable. For the non-marketed strengths 7000IU and 9000IU, the labels will be identical to the marketed strengths, except for the product strength. | Supply | Prescription medicines |
| epoetin lambda (rch) (NOVICRIT) 5,000 IU/0.5 mL solution for injection syringe | Sandoz Pty Ltd | 147859 | 1504140156, Qty 190, Expiry 01/2017 1505120109, Qty 1319, Expiry 01/2017 1601120015, Qty 1516, Expiry 01/2018 | CON-40 | The consent is effective from the 18 February 2016 until the 31 August 2016. | 18/02/2016 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69-General requirements for labels for medicines. | The packaging and labels will contain the former sponsor's (Novartis) name and phone contact details and to continue supply of existing stocks with the currently approved labels until 31 August 2016, following the transfer of sponsorship from Novartis to Sandoz. | A category 3 application to vary the labels to be compliant with paragraph 3(2)(I)of the Therapeutic Goods Order No. 69- General requirements for labels for medicines will be submitted to the Therapeutic Goods Administration for approval in February 2016. Sandoz Pty Ltd (the current sponsor) and Novartis Pharmaceuticals Australia Pty Ltd (the previous sponsor) have in place, for the period of this exemption, agreements and standard operating procedures (SOP) to cover the products, to ensure that any adverse events, products complaints or consumer enquiries reported to one party to the agreements are shared and directed to the most relevant party as applicable. For the non-marketed strengths 7000IU and 9000IU, the labels will be identical to the marketed strengths, except for the product strength. | Supply | Prescription medicines |
| epoetin lambda (rch) (NOVICRIT ) 4,000 IU/0.4 mL solution for injection syringe | Sandoz Pty Ltd | 147843 | 1506220038, Qty 821, Expiry 02/2017 1508260051, Qty 1561, Expiry 02/2017 | CON-40 | The consent is effective from the 18 February 2016 until the 31 August 2016. | 18/02/2016 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69-General requirements for labels for medicines. | The packaging and labels will contain the former sponsor's (Novartis) name and phone contact details and to continue supply of existing stocks with the currently approved labels until 31 August 2016, following the transfer of sponsorship from Novartis to Sandoz. | A category 3 application to vary the labels to be compliant with paragraph 3(2)(I)of the Therapeutic Goods Order No. 69- General requirements for labels for medicines will be submitted to the Therapeutic Goods Administration for approval in February 2016. Sandoz Pty Ltd (the current sponsor) and Novartis Pharmaceuticals Australia Pty Ltd (the previous sponsor) have in place, for the period of this exemption, agreements and standard operating procedures (SOP) to cover the products, to ensure that any adverse events, products complaints or consumer enquiries reported to one party to the agreements are shared and directed to the most relevant party as applicable. For the non-marketed strengths 7000IU and 9000IU, the labels will be identical to the marketed strengths, except for the product strength. | Supply | Prescription medicines |
| epoetin lambda (rch) (NOVICRIT) 3,000 IU/0.3 mL solution for injection syringe | Sandoz Pty Ltd | 147849 | 1506220016, Qty 335, Expiry 01/2017 1512230051, Qty 763, Expiry 09/2017 1512180005, Qty 751, Expiry 09/2017 | CON-40 | The consent is effective from the 18 February 2016 until the 31 August 2016. | 18/02/2016 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69-General requirements for labels for medicines. | The packaging and labels will contain the former sponsor's (Novartis) name and phone contact details and to continue supply of existing stocks with the currently approved labels until 31 August 2016, following the transfer of sponsorship from Novartis to Sandoz. | A category 3 application to vary the labels to be compliant with paragraph 3(2)(I)of the Therapeutic Goods Order No. 69- General requirements for labels for medicines will be submitted to the Therapeutic Goods Administration for approval in February 2016. Sandoz Pty Ltd (the current sponsor) and Novartis Pharmaceuticals Australia Pty Ltd (the previous sponsor) have in place, for the period of this exemption, agreements and standard operating procedures (SOP) to cover the products, to ensure that any adverse events, products complaints or consumer enquiries reported to one party to the agreements are shared and directed to the most relevant party as applicable. For the non-marketed strengths 7000IU and 9000IU, the labels will be identical to the marketed strengths, except for the product strength. | Supply | Prescription medicines |
| epoetin lambda (rch) (NOVICRIT) 2,000 IU/1.0 mL solution for injection syringe | Sandoz Pty Ltd | 147833 | 1508190048, Qty 445, Expiry 01/2017 1509230091, Qty 750, Expiry 03/2017 | CON-40 | The consent is effective from the 18 February 2016 until the 31 August 2016. | 18/02/2016 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69-General requirements for labels for medicines. | The packaging and labels will contain the former sponsor's (Novartis) name and phone contact details and to continue supply of existing stocks with the currently approved labels until 31 August 2016, following the transfer of sponsorship from Novartis to Sandoz. | A category 3 application to vary the labels to be compliant with paragraph 3(2)(I)of the Therapeutic Goods Order No. 69- General requirements for labels for medicines will be submitted to the Therapeutic Goods Administration for approval in February 2016. Sandoz Pty Ltd (the current sponsor) and Novartis Pharmaceuticals Australia Pty Ltd (the previous sponsor) have in place, for the period of this exemption, agreements and standard operating procedures (SOP) to cover the products, to ensure that any adverse events, products complaints or consumer enquiries reported to one party to the agreements are shared and directed to the most relevant party as applicable. For the non-marketed strengths 7000IU and 9000IU, the labels will be identical to the marketed strengths, except for the product strength. | Supply | Prescription medicines |
| epoetin lambda (rch) (NOVICRIT) 1,000 IU/0.5 mL solution for injection syringe | Sandoz Pty Ltd | 147847 | 1505130276, Qty 100, Expiry 01/2017 1505130277, Qty 43, Expiry 01/2017 1512230052, Qty 100, Expiry 08/2017 | CON-40 | The consent is effective from the 18 February 2016 until the 31 August 2016. | 18/02/2016 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69-General requirements for labels for medicines. | The packaging and labels will contain the former sponsor's (Novartis) name and phone contact details and to continue supply of existing stocks with the currently approved labels until 31 August 2016, following the transfer of sponsorship from Novartis to Sandoz. | A category 3 application to vary the labels to be compliant with paragraph 3(2)(I)of the Therapeutic Goods Order No. 69- General requirements for labels for medicines will be submitted to the Therapeutic Goods Administration for approval in February 2016. Sandoz Pty Ltd (the current sponsor) and Novartis Pharmaceuticals Australia Pty Ltd (the previous sponsor) have in place, for the period of this exemption, agreements and standard operating procedures (SOP) to cover the products, to ensure that any adverse events, products complaints or consumer enquiries reported to one party to the agreements are shared and directed to the most relevant party as applicable. For the non-marketed strengths 7000IU and 9000IU, the labels will be identical to the marketed strengths, except for the product strength. | Supply | Prescription medicines |
| meningococcal polysaccharide (MENCEVAX ACWY) vaccine powder for injection single dose vial with diluent vial | Pfizer Australia | 145887 | CON-42 | The consent is effective from 19 February 2016 until 19 February 2018. | 19/02/2016 | Paragraph 3(2)(l) of Therapeutic Goods Order Number 69, General requirements for labels for medicines. | The products will be supplied in labels containing the name and address of the previous sponsor (GlaxoSmithKline Australia Pty Ltd) rather than the current sponsor (Pfizer Australia). | The labels to which this consent applies are those previously approved for the former sponsor GlaxoSmithKline Australia Pty Ltd. Arrangements are in place with the former sponsor GlaxoSmithKline Australia Pty Ltd for the prompt referral of any queries or complaints concerning the products to Pfizer Australia as stated in the letter of application dated 2 February 2016. | Import and supply | Prescription medicines | |
| meningococcal polysaccharide (MENCEVAX ACWY) vaccine powder for injection single dose vial with diluent syringe | Pfizer Australia | 204478 | CON-42 | The consent is effective from 19 February 2016 until 19 February 2018. | 19/02/2016 | Paragraph 3(2)(l) of Therapeutic Goods Order Number 69, General requirements for labels for medicines. | The products will be supplied in labels containing the name and address of the previous sponsor (GlaxoSmithKline Australia Pty Ltd) rather than the current sponsor (Pfizer Australia). | The labels to which this consent applies are those previously approved for the former sponsor GlaxoSmithKline Australia Pty Ltd. Arrangements are in place with the former sponsor GlaxoSmithKline Australia Pty Ltd for the prompt referral of any queries or complaints concerning the products to Pfizer Australia as stated in the letter of application dated 2 February 2016. | Import and supply | Prescription medicines | |
| meningococcal (NIMENRIX ) (Groups A, C, W-135, Y) Polysaccharide Tetanus Toxoid Conjugate Vaccine, injection vial and diluent syringe | Pfizer Australia | 199742 | CON-41 | The consent is effective from 19 February 2016 until 19 February 2018. | 19/02/2016 | Paragraph 3(2)(l) of Therapeutic Goods Order Number 69, General requirements for labels for medicines. | The products will be supplied in labels containing the name and address of the previous sponsor (GlaxoSmithKline Australia Pty Ltd) rather than the current sponsor (Pfizer Australia). | The labels to which this consent applies are those previously approved for the former sponsor GlaxoSmithKline Australia Pty Ltd. Arrangements are in place with the former sponsor GlaxoSmithKline Australia Pty Ltd for the prompt referral of any queries or complaints concerning the products to Pfizer Australia as stated in the letter of application dated 2 February 2016. | Import and supply | Prescription medicines | |
| meningococcal (NIMENRIX ) (Groups A, C, W-135, Y) Polysaccharide Tetanus Toxoid Conjugate Vaccine, injection vial and diluent ampoule | Pfizer Australia | 199741 | CON-41 | The consent is effective from 19 February 2016 until 19 February 2018. | 19/02/2016 | Paragraph 3(2)(l) of Therapeutic Goods Order Number 69, General requirements for labels for medicines. | The products will be supplied in labels containing the name and address of the previous sponsor (GlaxoSmithKline Australia Pty Ltd) rather than the current sponsor (Pfizer Australia). | The labels to which this consent applies are those previously approved for the former sponsor GlaxoSmithKline Australia Pty Ltd. Arrangements are in place with the former sponsor GlaxoSmithKline Australia Pty Ltd for the prompt referral of any queries or complaints concerning the products to Pfizer Australia as stated in the letter of application dated 2 February 2016. | Import and supply | Prescription medicines | |
| artemether/lumefantrine 20 mg/120 mg (RIAMET) 20 mg/120 mg dispersible tablet blister pack | Novartis Pharmaceuticals Australia Pty Ltd | 158523 | CON-43 | The consent is effective from 24 February 2016 until 24 February 2018. | 24/02/2016 | Paragraph 3(2)(a) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The tablet blister foils state a different trade name. | A 'Dear Healthcare Provider' letter identical to that provided to the Therapeutic Goods Administration in the letter dated 11 February 2016 (TGA reference R16/120173), and amended as described in the email dated 24 February 2016 (TGA reference R16/137094), will be supplied to healthcare professionals, as proposed in the letter dated 11 February 2016, advising consumers to keep the blister trays in the correctly labelled cartons; A patient leaflet identical to that provided to the Therapeutic Goods Administration on 24 February 2016 (TGA reference R16/136531) will be distributed to patients advising consumers to keep the blisters in the cartons and that the presentation is as intended; and The blister labels to which this consent applies are those provided in the letter of application. | Import and supply | Prescription medicines | |
| rasagiline mesilate (AZILECT) tablet blister pack | Teva Pharma Australia Pty Ltd | 170172 | CON-45 | The consent is effective from the 26 February 2016 until the 30 November 2016. | 26/02/2016 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The sponsor details on the labels are those of a previous sponsor. | The labels to which this consent applies are those previously approved for the former sponsor, Lundbeck Australia Pty Ltd, and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to the current sponsor, Teva Pharma Australia Pty Ltd. | Import and supply | Prescription medicines | |
| RIKODEINE 9.5mg/5mL oral liquid bottle | iNova Pharmaceuticals Australia Pty Ltd | 10587 | 1045550 | CON-44 | The consent is effective from 3 March 2016 until 30 June 2016. | 3/03/2016 | Paragraph 3(2)(l) of Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The product labels show the previous registered address of the sponsor. | Arrangements are in place for the prompt referral of any queries or complaints concerning the products received at the previous address to the current address. | Supply | Over-the-counter medicines |
| Coles Tampons Regular 20 and 40 pack Coles Tampons Super 16 and 32 pack | Ontex Manufacturing Pty Ltd | 273391 | CON-59 | The consent is effective from 21 March 2016 until the 21 September 2016. | 21/03/2016 | Therapeutic Goods Order No 82 - Standard for Tampons - Menstrual and Therapeutic Goods Order 37 - General Requirements for Labels for Therapeutic Devices. | Specifically the Products do not comply with the clauses 7.1, 10.2, 10.3 and 11 of the Australian/New Zealand Standard 'AS/NZS 2869%2358;2008 Tampons - Menstrual' | It is anticipated that the stock of this type of therapeutic goods likely should be exhausted during the period of no more than six months. The consent is effective from 21 March 2016. | Import and supply | Other therapeutic goods listed | |
| vandetanib (CAPRELSA) 300mg film coated tablet blister pack | Sanofi-Aventis Australia Pty Ltd | 192497 | CON-47 | The consent is effective from the 1 April 2016 until 31 March 2017 | 1/04/2016 | Paragraph 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels do not include the name and address details of the current sponsor | The labels to which this consent applies are those previously approved for the former sponsor, AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Sanofi-Aventis Australia Pty Ltd, the current sponsor | Import and supply | Prescription medicines | |
| vandetanib (CAPRELSA) 100mg film coated tablet blister pack | Sanofi-Aventis Australia Pty Ltd | 192496 | CON-47 | The consent is effective from the 1 April 2016 until 31 March 2017 | 1/04/2016 | Paragraph 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels do not include the name and address details of the current sponsor | The labels to which this consent applies are those previously approved for the former sponsor, AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Sanofi-Aventis Australia Pty Ltd, the current sponsor | Import and supply | Prescription medicines | |
| lumacaftor/ivacaftor (ORKAMBI 200/125) 200mg/125mg film-coated tablet blister pack | Vertex Pharmaceuticals Australia Pty Ltd | 235759 | CON-46 | The consent is effective from 1 April 2016 until 1 October 2016. | 1/04/2016 | Paragraphs 3(2) and 3(13) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels do not include the product name and do not use a permitted statement of storage conditions. | The tablets are otherwise the same as those registered; The carton in which the product is supplied has text corresponding to that identified in the email of the 31 March 2016; and The cartons are marked with, or have added, the ARTG registration number 235759. | Import and supply | Prescription medicines | |
| gadoversetamide (OPTIMARK) 15.0 mmol/30 mL injection syringe | Mallinckrodt Australia Pty Ltd | 76658 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| gadoversetamide (OPTIMARK) 10.0 mmol/20 mL injection syringe | Mallinckrodt Australia Pty Ltd | 76657 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| gadoversetamide (OPTIMARK) 7.5 mmol/15 mL injection syringe | Mallinckrodt Australia Pty Ltd | 76656 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| gadoversetamide (OPTIMARK) 5.0 mmol/10 mL injection syringe | Mallinckrodt Australia Pty Ltd | 75486 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| gadoversetamide (OPTIMARK) 2.5 mmol/5 mL injection vial | Mallinckrodt Australia Pty Ltd | 75485 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 320 ULTRAJECT) 50.8 g/75 mL injection syringe | Mallinckrodt Australia Pty Ltd | 73580 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 350) 74% w/v 55.575 g/75 mL injection syringe | Mallinckrodt Australia Pty Ltd | 70059 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 350) 92.6 g/125 mL injection syringe | Mallinckrodt Australia Pty Ltd | 61984 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 350) 74.1 g/100 mL injection syringe | Mallinckrodt Australia Pty Ltd | 61983 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| Ioversol (OPTIRAY 350 ULTRAJECT) 74% w/v 37.05 g/50 mL injection syringe | Mallinckrodt Australia Pty Ltd | 51796 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 350 ULTRAJECT) 74% w/v 22.23 g/30 mL injection syringe | Mallinckrodt Australia Pty Ltd | 51795 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| iotalamate meglumine (CONRAY-280) 30 g/50 mL injection vial | Mallinckrodt Australia Pty Ltd | 51542 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| iotalamate meglumine (CONRAY-280) 12 g/20 mL injection vial | Mallinckrodt Australia Pty Ltd | 51541 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 350) 74% w/v 148.2 g/200 mL injection vial | Mallinckrodt Australia Pty Ltd | 49612 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 350) 74% w/v 111.14 g/150 mL injection vial | Mallinckrodt Australia Pty Ltd | 49611 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 350) 74% w/v 14.82 g/20 mL injection vial | Mallinckrodt Australia Pty Ltd | 49610 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 320) 135.6 g/200 mL injection vial | Mallinckrodt Australia Pty Ltd | 49425 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 320) 101.7 g/150 mL injection vial | Mallinckrodt Australia Pty Ltd | 49424 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 320) 67.8 g/100 mL injection vial | Mallinckrodt Australia Pty Ltd | 49423 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 320) 33.9 g/50 mL injection vial | Mallinckrodt Australia Pty Ltd | 49422 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 320) 20.34 g/30 mL injection vial | Mallinckrodt Australia Pty Ltd | 49421 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 240) 25.45 g/50 mL injection bottle | Mallinckrodt Australia Pty Ltd | 49410 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 350) 74% w/v 74.1 g/100 mL injection vial | Mallinckrodt Australia Pty Ltd | 47998 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 350) 74% w/v 55.575 g/75 mL injection vial | Mallinckrodt Australia Pty Ltd | 47997 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 350) 74% w/v 37.05 g/50 mL injection vial | Mallinckrodt Australia Pty Ltd | 47856 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 350) 74% w/v 22.23 g/30 mL injection vial | Mallinckrodt Australia Pty Ltd | 47856 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 320) 678 mg/mL 125 mL injection syringe (power injector) | Mallinckrodt Australia Pty Ltd | 46642 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 320) 678 mg/mL 50 mL injection syringe (hand held and power injector) | Mallinckrodt Australia Pty Ltd | 46641 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 240) 636.25 g/125 mL injection syringe (power injector) | Mallinckrodt Australia Pty Ltd | 46640 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| ioversol (OPTIRAY 320) 13.56 g/20 mL injection vial | Mallinckrodt Australia Pty Ltd | 20034 | CON-51 | The consent is effective from 5 April 2016 until 31 March 2017. | 5/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product labels state the Sponsor's previous name. | The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name. | Import and supply | Prescription medicines | |
| pirfenidone (ESBRIET) 267 mg hard capsule bottle | Roche Products Pty Ltd | 235577 | CON-49 | The consent is effective from 5 April 2016 until the 1 December 2016. | 5/04/2016 | Subclauses 3(2)(a) and (g) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The product label does not state the product name or the appropriate warning statements. | The labels to which this consent applies are those provided with the letter of application, over-stickered with the AUST R number as per the assurance provided 29/03/2016 and; Supply of the affected batches will be to practitioners already familiar with the above mentioned labels. | Supply | Prescription medicines | |
| lisinopril (as dihydrate) (ZINOPRIL 10) 10 mg tablet blister pack | Alphapharm Pty Ltd | 152717 | EZX015001 | CON-48 | The consent is effective from the 5 April 2016 for batch number EZX015001 until 04 April 2017. | 5/04/2016 | Subclauses 3(2)(h) and (i) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The batch number and expiry date of the product are not preceded by the appropriate prefixes on the blister foil. | A 'Dear Healthcare Provider' letter identical to that provided to the TGA on 02 March 2016 (TGA reference R16/179766) advising them to remind patients to keep the blister packs with the correctly labelled carton, must be provided with the affected batch. | Import and supply | Prescription medicines |
| diclofenac diethylamine (VOLTAREN OSTEO GEL 12 HOURLY) 23.2 mg/g gel tube | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 219514 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| diclofenac diethylamine (VOLTAREN EMULGEL) 11.6 mg/g gel tube | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 47676 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| Diclofenac Potassium (VOLTAREN RAPID 25) 25 mg tablet | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 42942 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| diclofenac potassium (VOLTAREN RAPID 12.5) 12.5 mg film coated tablet blister pack (reformulation) | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 168061 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| diclofenac potassium (VOLTAREN RAPID 12.5 LIQUID CAPSULE) 12.5 mg soft capsule blister pack | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 171307 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| diclofenac diethylamine (VOLTAREN OSTEO GEL) 11.6 mg/g tube | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 175889 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| oxerutins (PAROVEN FORTE) 500 mg tablet blister pack | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 52171 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| oxerutins (PAROVEN) 250 mg capsule blister pack | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 60271 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| pump actuated metered dose aerosol (OTRIVIN PLUS NASAL SPRAY) | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 178401 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| xylometazoline hydrochloride (OTRIVIN JUNIOR NASAL DROPS) 0.5 mg/mL bottle (new formulation) | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 142226 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| xylometazoline hydrochloride (OTRIVIN JUNIOR NASAL SPRAY) 0.5 mg/mL pump actuated metered dose aerosol | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 142227 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| xylometazoline hydrochloride (OTRIVIN ADULT NASAL DROPS) 1 mg/mL bottle (new formulation) | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 142193 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| xylometazoline hydrochloride (OTRIVIN MENTHOL ADULT METERED DOSE NASAL SPRAY) 1.0 mg/mL aerosol - pump actuated | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 99690 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| xylometazoline hydrochloride (OTRIVIN ADULT NASAL SPRAY) 1 mg/mL pump actuated metered dose aerosol (reformulation) | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 142197 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| terbinafine hydrochloride (LAMISIL SPRAY) 10 mg/g spray solution aerosol pump actuated | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 59716 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| terbinafine (LAMISIL ONCE) 10 mg/g (as hydrochloride) collodion tube | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 124887 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| terbinafine (LAMISIL JOCK ITCH DERMGEL) 10 mg/g tube | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 121514 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| terbinafine (LAMISIL DERMGEL) 10 mg/g tube | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 63434 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| terbinafine hydrochloride (LAMISIL CREAM) 10 mg/g tube | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 43524 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| eurax cream | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 11033 | CON-50 | The consent is effective from 6 April 2016 until 5 April 2018. | 6/04/2016 | Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not include the name and address of the current sponsor or supplier of the goods. | 1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor. | Supply | Over-the-counter medicines | |
| erythromycin EES (as ethyl succinate) 400 mg/5 mL granules for oral liquid bottle | Amdipharm Mercury Australia Pty Ltd | 54456 | CON-56 | The consent is effective from 18 April 2016 to: 30 September 2016 (for ARTG 131444) 28 February 2017 (for ARTG 173634) 30 September 2016 (for ARTG 54456) | 18/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | the labels state the former Sponsor's name and contact details. | The labels to which this consent applies are those previously approved for the former sponsor Link Medical Products Pty Ltd (Link) and arrangements are in place with the former sponsor Link for the prompt referral of any queries or complaints concerning the products to Amdipharm Mercury Australia Pty Ltd (the current sponsor). | Import and supply | Prescription medicines | |
| erythromycin (EES) 200 mg/5 mL (as ethylsuccinate) granules for oral liquid bottle | Amdipharm Mercury Australia Pty Ltd | 173634 | CON-56 | The consent is effective from 18 April 2016 to: 30 September 2016 (for ARTG 131444) 28 February 2017 (for ARTG 173634) 30 September 2016 (for ARTG 54456) | 18/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | the labels state the former Sponsor's name and contact details. | The labels to which this consent applies are those previously approved for the former sponsor Link Medical Products Pty Ltd (Link) and arrangements are in place with the former sponsor Link for the prompt referral of any queries or complaints concerning the products to Amdipharm Mercury Australia Pty Ltd (the current sponsor). | Import and supply | Prescription medicines | |
| erythromycin (ERYTHROCIN IV) 1 g (as lactobionate) powder for injection vial | Amdipharm Mercury Australia Pty Ltd | 131444 | CON-56 | The consent is effective from 18 April 2016 to: 30 September 2016 (for ARTG 131444) 28 February 2017 (for ARTG 173634) 30 September 2016 (for ARTG 54456) | 18/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | the labels state the former Sponsor's name and contact details. | The labels to which this consent applies are those previously approved for the former sponsor Link Medical Products Pty Ltd (Link) and arrangements are in place with the former sponsor Link for the prompt referral of any queries or complaints concerning the products to Amdipharm Mercury Australia Pty Ltd (the current sponsor). | Import and supply | Prescription medicines | |
| LOCACORTEN-VIOFORM ear drops bottle | Amdipharm Mercury Australia Pty Ltd | 11040 | CON-55 | The consent is effective from 18 April 2016 until 31 July 2016. | 18/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The product labels state the former Sponsor's name and contact details | The labels to which this consent applies are those previously approved for the former sponsor Link Medical Products Pty Ltd (Link) and arrangements are in place with the former sponsor Link for the prompt referral of any queries or complaints concerning the products to Amdipharm Mercury Australia Pty Ltd (the current sponsor). | Import and supply | Prescription medicines | |
| chlortalidone (HYGROTON 25) 25 mg tablet bottle | Amdipharm Mercury Australia Pty Ltd | 11035 | CON-54 | The consent is effective from 18 April 2016 until 30 September 2016. | 18/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The labels state the former Sponsor's name and contact details. | The labels to which this consent applies are those previously approved for the former sponsor Link Medical Products Pty Ltd (Link) and arrangements are in place with the former sponsor Link for the prompt referral of any queries or complaints concerning the products to Amdipharm Mercury Australia Pty Ltd (the current sponsor). | Import and supply | Prescription medicines | |
| carbimazole (NEO-MERCAZOLE) 5 mg tablet bottle | Amdipharm Mercury Australia Pty Ltd | 194296 | CON-53 | The consent is effective from 18 April 2016 until 30 June 2016. | 18/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The labels state the former Sponsor's name and contact details. | The labels to which this consent applies are those previously approved for the former sponsor Link Medical Products Pty Ltd (Link) and arrangements are in place with the former sponsor Link for the prompt referral of any queries or complaints concerning the products to Amdipharm Mercury Australia Pty Ltd (the current sponsor). | Import and supply | Prescription medicines | |
| hydralazine hydrochloride (APRESOLINE) 20 mg powder for injection ampoule | Amdipharm Mercury Australia Pty Ltd | 43190 | CON-52 | The consent is effective 18 April 2016 until 31 December 2016. | 18/04/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The labels state the former Sponsor's name and contact details. | The labels to which this consent applies are those previously approved for the former sponsor Link Medical Products Pty Ltd (Link) and arrangements are in place with the former sponsor Link for the prompt referral of any queries or complaints concerning the products to Amdipharm Mercury Australia Pty Ltd (the current sponsor). | Import and supply | Prescription medicines | |
| eftrenonacog alfa (ALPROLIX) (rhu) 3000 IU powder for injection vial and diluent pre-filled syringe | Biogen Australia Pty Ltd | 209226 | CON-58 | The consent is effective from 20 April 2016 until 20 April 2018 | 20/04/2016 | Subclauses 3(2)(l), 3(2)(e), 3(2)(m) and 3(5)(a)(ii) of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | Old name and street address of the sponsor is on the primary label (i.eBiogen Idec Australia Pty Ltd and suite 1, level 5, 123 Epping Road. only the word quot;Powderquot; was stated on the primary label instead of quot;Powder for injectionquot; As the products are exempt from scheduling, the statement of purpose or purposes for which the goods are intended was not stated on the primary label The word quot;for injectionquot; was not stated adjacent to the product name on the primary label | This exemption is applicable to batches of the products labels warehoused in Australia, those already produced, labelled and packed for Australia and held in overseas warehousing, or those currently in production for Australia. A commitment to update and implement the products labels with correct company name (Biogen Australia Pty Ltd), street address (suite 1, level 3, 123 Epping Road) and changes to artwork as requested by the Biochemistry Section of the TGA in line with TGO 69 as soon as practicable. This exemption is applicable only to products listed in this approval letter. | Supply | Prescription medicines | |
| eftrenonacog alfa (ALPROLIX) (rhu) 2000 IU powder for injection vial and diluent pre-filled syringe | Biogen Australia Pty Ltd | 209225 | CON-58 | The consent is effective from 20 April 2016 until 20 April 2018 | 20/04/2016 | Subclauses 3(2)(l), 3(2)(e), 3(2)(m) and 3(5)(a)(ii) of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | Old name and street address of the sponsor is on the primary label (i.eBiogen Idec Australia Pty Ltd and suite 1, level 5, 123 Epping Road. only the word quot;Powderquot; was stated on the primary label instead of quot;Powder for injectionquot; As the products are exempt from scheduling, the statement of purpose or purposes for which the goods are intended was not stated on the primary label The word quot;for injectionquot; was not stated adjacent to the product name on the primary label | This exemption is applicable to batches of the products labels warehoused in Australia, those already produced, labelled and packed for Australia and held in overseas warehousing, or those currently in production for Australia. A commitment to update and implement the products labels with correct company name (Biogen Australia Pty Ltd), street address (suite 1, level 3, 123 Epping Road) and changes to artwork as requested by the Biochemistry Section of the TGA in line with TGO 69 as soon as practicable. This exemption is applicable only to products listed in this approval letter. | Supply | Prescription medicines | |
| eftrenonacog alfa (ALPROLIX) (rhu) 1000 IU powder for injection vial and diluent pre-filled syringe | Biogen Australia Pty Ltd | 209224 | CON-58 | The consent is effective from 20 April 2016 until 20 April 2018 | 20/04/2016 | Subclauses 3(2)(l), 3(2)(e), 3(2)(m) and 3(5)(a)(ii) of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | Old name and street address of the sponsor is on the primary label (i.eBiogen Idec Australia Pty Ltd and suite 1, level 5, 123 Epping Road. only the word quot;Powderquot; was stated on the primary label instead of quot;Powder for injectionquot; As the products are exempt from scheduling, the statement of purpose or purposes for which the goods are intended was not stated on the primary label The word quot;for injectionquot; was not stated adjacent to the product name on the primary label | This exemption is applicable to batches of the products labels warehoused in Australia, those already produced, labelled and packed for Australia and held in overseas warehousing, or those currently in production for Australia. A commitment to update and implement the products labels with correct company name (Biogen Australia Pty Ltd), street address (suite 1, level 3, 123 Epping Road) and changes to artwork as requested by the Biochemistry Section of the TGA in line with TGO 69 as soon as practicable. This exemption is applicable only to products listed in this approval letter. | Supply | Prescription medicines | |
| eftrenonacog alfa (ALPROLIX) (rhu) 500 IU powder for injection vial and diluent pre-filled syringe | Biogen Australia Pty Ltd | 209223 | CON-58 | The consent is effective from 20 April 2016 until 20 April 2018 | 20/04/2016 | Subclauses 3(2)(l), 3(2)(e), 3(2)(m) and 3(5)(a)(ii) of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | Old name and street address of the sponsor is on the primary label (i.eBiogen Idec Australia Pty Ltd and suite 1, level 5, 123 Epping Road. only the word quot;Powderquot; was stated on the primary label instead of quot;Powder for injectionquot; As the products are exempt from scheduling, the statement of purpose or purposes for which the goods are intended was not stated on the primary label The word quot;for injectionquot; was not stated adjacent to the product name on the primary label | This exemption is applicable to batches of the products labels warehoused in Australia, those already produced, labelled and packed for Australia and held in overseas warehousing, or those currently in production for Australia. A commitment to update and implement the products labels with correct company name (Biogen Australia Pty Ltd), street address (suite 1, level 3, 123 Epping Road) and changes to artwork as requested by the Biochemistry Section of the TGA in line with TGO 69 as soon as practicable. This exemption is applicable only to products listed in this approval letter. | Supply | Prescription medicines | |
| zanamivir (RELENZA ROTADISKS) 5 mg insufflation blister pack | GlaxoSmithKline Australia Ltd | 66962 | CON-57 | The consent is effective from 20 April 2016 until 21 April 2018. | 20/04/2016 | Sub-clause 2(1) of Therapeutic Goods Order (TGO) 69 - General requirements for labels for medicines. | the product is to be supplied with a 10 year shelf life. Sub-clause 2(1) of the Order stipulates that the expiry is a date not more than 5 years after the date of manufacture. | Import, supply and export | Prescription medicines | ||
| calsource Ca 1000 | GlaxoSmithKline Healthcare Australia Pty Ltd | 146629 | CON-61 | The consent is effective from 6 May 2016 until 13 March 2018. | 6/05/2016 | Subclauses 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The products will be supplied in labels containing the name and address of the previous sponsor (Novartis Consumer Health Australasia Pty Ltd), rather than the current sponsor (GlaxoSmithKline Consumer Healthcare Australia Pty Ltd). | arrangements are in place with the former sponsor (Novartis Consumer Health Australasia Pty Ltd), for the prompt referral of any queries or complaints concerning the product to the current sponsor (GlaxoSmithKline%23160;Consumer Healthcare Australia Pty Ltd). | Supply | Listed complementary medicines | |
| amifostine (as trihydrate) (ETHYOL) 500 mg powder for injection vial | Link Medical Products Pty Ltd | 63789 | CK 2071 | CON-60 | The consent is effective from the 18 May 2016 until 31 January 2017. | 18/05/2016 | sub-clause 3(1)(a) of the Therapeutic Goods Order No. 69. | The information on the carton and vial labels are not in the English language. | The 'Dear Healthcare Professional' letter identical to that provided to the TGA by the company must be supplied with each dispensed unit of batch CK 2071 of the product. The carton and vial labels for batch CK 2071 are identical to the representative French product labels provided in the application. The main panel of the carton label must be over-stickered with the over-label provided with the application. %23160; The French package insert must be replaced with the Australian package insert in each dispensed unit of batch CK 2071 of the product. | Import and supply | Prescription medicines |
| normal immunoglobulin (Human) (FLEBOGAMMA 10% DIF) 20 g/200 mL intravenous use injection vial | Grifols Australia Pty Ltd | 182359 | CON-64 | The consent is effective from 23 May 2016 until 23 May 2017 | 23/05/2016 | subclause 3(2)(l) of Therapeutic Goods Order No 69 – (TGO 69) General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) | Vial labels do not include the name and address of the current sponsor (Grifols Australia; for AUST R 143800, 143801, 143802, 143803, 184353, 182358 and 182359) and carton labels do not show the signal words, PRESCRIPTION ONLY MEDICINES, on the first line. | An assurance that Grifols Australia is seeking exemption for a period of 12 months only. During this period the vial and carton labels will be updated to meet the required standards and submitted as a section 9D(3) application to the TGA.Please note that a commitment to update and implement artwork to meet the requirements of the subclause 3(2)(l) of Therapeutic Goods Order No 69 – General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is not applicable to container label of AUST R 140602because the vial capacity is less than 20 mL. | Supply | Prescription medicines | |
| normal immunoglobulin (Human) (FLEBOGAMMA 10% DIF) 10 g/ 100 mL intravenous use injection vial | Grifols Australia Pty Ltd | 182358 | CON-64 | The consent is effective from 23 May 2016 until 23 May 2017 | 23/05/2016 | subclause 3(2)(l) of Therapeutic Goods Order No 69 – (TGO 69) General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) | Vial labels do not include the name and address of the current sponsor (Grifols Australia; for AUST R 143800, 143801, 143802, 143803, 184353, 182358 and 182359) and carton labels do not show the signal words, PRESCRIPTION ONLY MEDICINES, on the first line. | An assurance that Grifols Australia is seeking exemption for a period of 12 months only. During this period the vial and carton labels will be updated to meet the required standards and submitted as a section 9D(3) application to the TGA.Please note that a commitment to update and implement artwork to meet the requirements of the subclause 3(2)(l) of Therapeutic Goods Order No 69 – General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is not applicable to container label of AUST R 140602because the vial capacity is less than 20 mL. | Supply | Prescription medicines | |
| normal immunoglobulin (Human) (FLEBOGAMMA 10% DIF) 5 g/50 mL intravenous use injection vial | Grifols Australia Pty Ltd | 184353 | CON-64 | The consent is effective from 23 May 2016 until 23 May 2017 | 23/05/2016 | subclause 3(2)(l) of Therapeutic Goods Order No 69 – (TGO 69) General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) | Vial labels do not include the name and address of the current sponsor (Grifols Australia; for AUST R 143800, 143801, 143802, 143803, 184353, 182358 and 182359) and carton labels do not show the signal words, PRESCRIPTION ONLY MEDICINES, on the first line. | An assurance that Grifols Australia is seeking exemption for a period of 12 months only. During this period the vial and carton labels will be updated to meet the required standards and submitted as a section 9D(3) application to the TGA.Please note that a commitment to update and implement artwork to meet the requirements of the subclause 3(2)(l) of Therapeutic Goods Order No 69 – General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is not applicable to container label of AUST R 140602because the vial capacity is less than 20 mL. | Supply | Prescription medicines | |
| normal immunoglobulin (Human) FLEBOGAMMA 5% DIF 20 g/400 mL intravenous use injection vial | Grifols Australia Pty Ltd | 143803 | CON-64 | The consent is effective from 23 May 2016 until 23 May 2017 | 23/05/2016 | subclause 3(2)(l) of Therapeutic Goods Order No 69 – (TGO 69) General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) | Vial labels do not include the name and address of the current sponsor (Grifols Australia; for AUST R 143800, 143801, 143802, 143803, 184353, 182358 and 182359) and carton labels do not show the signal words, PRESCRIPTION ONLY MEDICINES, on the first line. | An assurance that Grifols Australia is seeking exemption for a period of 12 months only. During this period the vial and carton labels will be updated to meet the required standards and submitted as a section 9D(3) application to the TGA.Please note that a commitment to update and implement artwork to meet the requirements of the subclause 3(2)(l) of Therapeutic Goods Order No 69 – General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is not applicable to container label of AUST R 140602because the vial capacity is less than 20 mL. | Supply | Prescription medicines | |
| normal immunoglobulin (Human) (FLEBOGAMMA 5%) 10 g/200 mL intravenous use injection vial | Grifols Australia Pty Ltd | 143802 | CON-64 | The consent is effective from 23 May 2016 until 23 May 2017 | 23/05/2016 | subclause 3(2)(l) of Therapeutic Goods Order No 69 – (TGO 69) General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) | Vial labels do not include the name and address of the current sponsor (Grifols Australia; for AUST R 143800, 143801, 143802, 143803, 184353, 182358 and 182359) and carton labels do not show the signal words, PRESCRIPTION ONLY MEDICINES, on the first line. | An assurance that Grifols Australia is seeking exemption for a period of 12 months only. During this period the vial and carton labels will be updated to meet the required standards and submitted as a section 9D(3) application to the TGA.Please note that a commitment to update and implement artwork to meet the requirements of the subclause 3(2)(l) of Therapeutic Goods Order No 69 – General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is not applicable to container label of AUST R 140602because the vial capacity is less than 20 mL. | Supply | Prescription medicines | |
| normal immunoglobulin (Human) (FLEBOGAMMA 5% DIF) 5 g/100 mL intravenous use injection vial | Grifols Australia Pty Ltd | 143801 | CON-64 | The consent is effective from 23 May 2016 until 23 May 2017 | 23/05/2016 | subclause 3(2)(l) of Therapeutic Goods Order No 69 – (TGO 69) General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) | Vial labels do not include the name and address of the current sponsor (Grifols Australia; for AUST R 143800, 143801, 143802, 143803, 184353, 182358 and 182359) and carton labels do not show the signal words, PRESCRIPTION ONLY MEDICINES, on the first line. | An assurance that Grifols Australia is seeking exemption for a period of 12 months only. During this period the vial and carton labels will be updated to meet the required standards and submitted as a section 9D(3) application to the TGA.Please note that a commitment to update and implement artwork to meet the requirements of the subclause 3(2)(l) of Therapeutic Goods Order No 69 – General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is not applicable to container label of AUST R 140602because the vial capacity is less than 20 mL. | Supply | Prescription medicines | |
| normal immunoglobulin (Human) (FLEBOGAMMA 5% DIF) 2.5 g/50 mL intravenous use injection vial | Grifols Australia Pty Ltd | 143800 | CON-64 | The consent is effective from 23 May 2016 until 23 May 2017 | 23/05/2016 | subclause 3(2)(l) of Therapeutic Goods Order No 69 – (TGO 69) General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) | Vial labels do not include the name and address of the current sponsor (Grifols Australia; for AUST R 143800, 143801, 143802, 143803, 184353, 182358 and 182359) and carton labels do not show the signal words, PRESCRIPTION ONLY MEDICINES, on the first line. | An assurance that Grifols Australia is seeking exemption for a period of 12 months only. During this period the vial and carton labels will be updated to meet the required standards and submitted as a section 9D(3) application to the TGA.Please note that a commitment to update and implement artwork to meet the requirements of the subclause 3(2)(l) of Therapeutic Goods Order No 69 – General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is not applicable to container label of AUST R 140602because the vial capacity is less than 20 mL. | Supply | Prescription medicines | |
| normal immunoglobulin (Human) (FLEBOGAMMA 5% DIF) 0.5 g/10 mL intravenous use injection vial | Grifols Australia Pty Ltd | 140602 | CON-64 | The consent is effective from 23 May 2016 until 23 May 2017 | 23/05/2016 | subclause 3(2)(l) of Therapeutic Goods Order No 69 – (TGO 69) General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) | Vial labels do not include the name and address of the current sponsor (Grifols Australia; for AUST R 143800, 143801, 143802, 143803, 184353, 182358 and 182359) and carton labels do not show the signal words, PRESCRIPTION ONLY MEDICINES, on the first line. | An assurance that Grifols Australia is seeking exemption for a period of 12 months only. During this period the vial and carton labels will be updated to meet the required standards and submitted as a section 9D(3) application to the TGA. Please note that a commitment to update and implement artwork to meet the requirements of the subclause 3(2)(l) of Therapeutic Goods Order No 69 – General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is not applicable to container label of AUST R 140602 because the vial capacity is less than 20 mL. | Supply | Prescription medicines | |
| procarbazine (as hydrochloride)(Natulan) capsule 50 mg in blister pack | Link Medical Products Pty Ltd | 231199 | CON-62 | The consent is effective from 24th May 2016 until 31 May 2018. | 24/05/2016 | Sub-clause 3(13)(a) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The product does not comply with TGO No. 69 because the blister foil label to be used does not include the name or registered trademark of the sponsor. | The 'Dear Healthcare Professional' letter identical to that provided to the TGA via%23160;the electronic mail of 24 May 2016 will be supplied with each affected batch of the product. The blister foil label to which this consent applies is that provided with%23160;the application. Upon receipt in Australia, the product will be re-packed into currently approved Australian cartons with the Australian printed leaflet. %23160; %23160; | Import and supply | Prescription medicines | |
| bicalutamide (CALUTEX) blister pack 50 mg tablets blister pack | Aspen Pharma Pty Ltd | 135858 | 1942524 | CON-65 | The consent is effective from 2 June 2016. | 2/06/2016 | subclause 3(13)(a) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | one batch only of the product (Batch 1942524) that does not conform to the requirements of the Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69) in that the blister foil label does not include the required pre-fixes for batch number and expiry date. | The 'Dear Healthcare Professional/Pharmacist' letter identical to that provided to the TGA on 31 May 2016 will be supplied with the affected batch of product. The blister foil label to which this consent applies is that provided with your application. %23160; | Import and supply | Prescription medicines |
| Centrum Specialist Energy Plus | Pfizer Australia Pty Ltd | 264900 | CON-69 | The consent is effective from 3 June 2016 until 31 May 2018. | 3/06/2016 | Subclause 10(b) of the Therapeutic Goods Order No. 78 – Standards for Tablets and Capsules. | That content of the active ingredient ‘Panax ginseng standardised root extract’ (the herbal active ingredient) is more than 120.0% of the stated content on the label. | The content of the herbal active ingredient, ‘Panax ginseng standardised root extract’, must not be less than 90.0% and not more than 125.0% of the stated content of the label. | Import and supply | Listed complementary medicines | |
| MOVICOL LIQUID ORANGE FLAVOUR oral liquid concentrate bottle | Norgine Pty Ltd | 212114 | Batches 245415 and 245354 | CON-67 | The consent is effective from 10 June 2016 until April 2018. | 10/06/2016 | Subclauses 3(2)(e) and 3(2)(f) of the Therapeutic Goods Order No 69- General requirements for labels for medicines. | The bottle labels do not include the expiry date prefix and the batch number prefix. | Import and supply | Over-the-counter medicines | |
| TRIPACEL pertussis vaccine - acellular combined with diptheria and tetanus toxoids (adsorbed) 0.5 mL injection vial | Sanofi Pasteur Australia Pty Ltd | 63120 | lot C5079A Expiry 30 September 2018, Quantity 165,000 doses | CON-68 | The consent is effective from 16 June 2016 until 30 September 2018. | 16/06/2016 | Clause 3(2)(b) and Clause 3(2)(c) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The names of all active ingredients in the goods and the quantity or proportion of all active ingredients in the goods are not on the vial label. The European Pharmacopoeia, in that it is tested to international/Canadian, rather than Australian specifications, as detailed in the application letter. | a 'Dear Healthcare Professional' letter identical to that provided to the TGA on 16 June 2016 (TGA ref%2358; R16/460939) will be supplied with each affected batch, warning about the different age indication on the international vial label; the vials will be repacked into the approved Australian carton together with the approved Australian Product Information leaflet at the proposed site in the letter dated 3 June 2016; %23160;the company will provide TGA with a copy of the Biologics and Genetic Therapies Directorate (BGTD) release certificate for lot C5079A; and normal TGA lot release processes will apply to this batch except that the Canadian lot release protocol is different from the Australian version. | Import and supply | Prescription medicines |
| Midazolam (as hydrochloride) (MIDAZOLAM MYX) 15 mg/ 3 mL solution for injection ampoules | Accord Healthcare Pty Ltd | 207245 | CON-66 | The consent is effective from 16 June 2016 until 30 June 2017 | 16/06/2016 | Subclauses 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines TGO 69. | The labels do not include the name and address details of the current sponsor. | The labels to which this consent applies are those previously approved for the former sponsor, Mayne Pharma International Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Accord Healthcare Pty Ltd, the current sponsor. | Import and supply | Prescription medicines | |
| Midazolam (as hydrochloride) (MIDAZOLAM MYX) 5 mg/ 1 mL solution for injection ampoules | Accord Healthcare Pty Ltd | 207241 | CON-66 | The consent is effective from 16 June 2016 until 30 June 2017 | 16/06/2016 | Subclauses 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines TGO 69. | The labels do not include the name and address details of the current sponsor. | The labels to which this consent applies are those previously approved for the former sponsor, Mayne Pharma International Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Accord Healthcare Pty Ltd, the current sponsor. | Import and supply | Prescription medicines | |
| Midazolam (as hydrochloride) (MIDAZOLAM MYX) 5 mg/ 5 mL solution for injection ampoules | Accord Healthcare Pty Ltd | 207239 | CON-66 | The consent is effective from 16 June 2016 until 30 June 2017 | 16/06/2016 | Subclauses 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines TGO 69. | The labels do not include the name and address details of the current sponsor. | The labels to which this consent applies are those previously approved for the former sponsor, Mayne Pharma International Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Accord Healthcare Pty Ltd, the current sponsor. | Import and supply | Prescription medicines | |
| Midazolam (as hydrochloride) (MIDAZOLAM MYX) 50 mg/ 10 mL solution for injection ampoules | Accord Healthcare Pty Ltd | 207225 | CON-66 | The consent is effective from 16 June 2016 until 30 June 2017 | 16/06/2016 | Subclauses 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines TGO 69. | The labels do not include the name and address details of the current sponsor. | The labels to which this consent applies are those previously approved for the former sponsor, Mayne Pharma International Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Accord Healthcare Pty Ltd, the current sponsor. | Import and supply | Prescription medicines | |
| pemetrexed (as disodium) (PEMETREXED MYX) 100 mg powder for injection vial | Accord Healthcare Pty Ltd | 222420 | CON-66 | The consent is effective from 16 June 2016 until 30 June 2017 | 16/06/2016 | Subclauses 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines TGO 69. | The labels do not include the name and address details of the current sponsor. | The labels to which this consent applies are those previously approved for the former sponsor, Mayne Pharma International Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Accord Healthcare Pty Ltd, the current sponsor. | Import and supply | Prescription medicines | |
| pemetrexed (as disodium) (PEMETREXED MYX) 500 mg powder for injection vial | Accord Healthcare Pty Ltd | 222415 | CON-66 | The consent is effective from 16 June 2016 until 30 June 2017 | 16/06/2016 | Subclauses 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines TGO 69. | The labels do not include the name and address details of the current sponsor. | The labels to which this consent applies are those previously approved for the former sponsor, Mayne Pharma International Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Accord Healthcare Pty Ltd, the current sponsor. | Import and supply | Prescription medicines | |
| methotrexate (METHOTREXATE MYX) 1000 mg/ 10 mL injection vial | Accord Healthcare Pty Ltd | 213737 | CON-66 | The consent is effective from 16 June 2016 until 30 June 2017 | 16/06/2016 | Subclauses 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines TGO 69. | The labels do not include the name and address details of the current sponsor. | The labels to which this consent applies are those previously approved for the former sponsor, Mayne Pharma International Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Accord Healthcare Pty Ltd, the current sponsor. | Import and supply | Prescription medicines | |
| methotrexate (METHOTREXATE MYX) 50 mg/ 2 mL injection vial | Accord Healthcare Pty Ltd | 213736 | CON-66 | The consent is effective from 16 June 2016 until 30 June 2017 | 16/06/2016 | Subclauses 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines TGO 69. | The labels do not include the name and address details of the current sponsor. | The labels to which this consent applies are those previously approved for the former sponsor, Mayne Pharma International Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Accord Healthcare Pty Ltd, the current sponsor. | Import and supply | Prescription medicines | |
| capecitabine (CAPECITABINE MYX) 150 mg film-coated tablet blister pack | Accord Healthcare Pty Ltd | 213041 | CON-66 | The consent is effective from 16 June 2016 until 30 June 2017 | 16/06/2016 | Subclauses 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines TGO 69. | The labels do not include the name and address details of the current sponsor. | The labels to which this consent applies are those previously approved for the former sponsor, Mayne Pharma International Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Accord Healthcare Pty Ltd, the current sponsor. | Import and supply | Prescription medicines | |
| capecitabine (CAPECITABINE MYX) 500 mg film-coated tablet blister pack | Accord Healthcare Pty Ltd | 213034 | CON-66 | The consent is effective from 16 June 2016 until 30 June 2017 | 16/06/2016 | Subclauses 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines TGO 69. | The labels do not include the name and address details of the current sponsor. | The labels to which this consent applies are those previously approved for the former sponsor, Mayne Pharma International Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Accord Healthcare Pty Ltd, the current sponsor. | Import and supply | Prescription medicines | |
| irinotecan hydrochloride trihydrate (IRINOTECAN MYX) 100 mg/ 5 mL concentrated injection vial | Accord Healthcare Pty Ltd | 209857 | CON-66 | The consent is effective from 16 June 2016 until 30 June 2017 | 16/06/2016 | Subclauses 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines TGO 69. | The labels do not include the name and address details of the current sponsor. | The labels to which this consent applies are those previously approved for the former sponsor, Mayne Pharma International Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Accord Healthcare Pty Ltd, the current sponsor. | Import and supply | Prescription medicines | |
| ondansetron (as hydrochloride dihydrate) (ONDANSETRON MYX) 8 mg/ 4 mL injection ampoule | Accord Healthcare Pty Ltd | 205599 | CON-66 | The consent is effective from 16 June 2016 until 30 June 2017 | 16/06/2016 | Subclauses 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines TGO 69. | The labels do not include the name and address details of the current sponsor. | The labels to which this consent applies are those previously approved for the former sponsor, Mayne Pharma International Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Accord Healthcare Pty Ltd, the current sponsor. | Import and supply | Prescription medicines | |
| ondansetron (as hydrochloride dihydrate) (ONDANSETRON MYX) 4 mg/ 2 mL injection ampoule | Accord Healthcare Pty Ltd | 205594 | CON-66 | The consent is effective from 16 June 2016 until 30 June 2017 | 16/06/2016 | Subclauses 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines TGO 69. | The labels do not include the name and address details of the current sponsor. | The labels to which this consent applies are those previously approved for the former sponsor, Mayne Pharma International Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Accord Healthcare Pty Ltd, the current sponsor. | Import and supply | Prescription medicines | |
| doxorubicin hydrochloride (DOXORUBICIN MYX) 200 mg/ 100 mL concentrated solution for injection vial | Accord Healthcare Pty Ltd | 174248 | CON-66 | The consent is effective from 16 June 2016 until 30 June 2017 | 16/06/2016 | Subclauses 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines TGO 69. | The labels do not include the name and address details of the current sponsor. | The labels to which this consent applies are those previously approved for the former sponsor, Mayne Pharma International Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Accord Healthcare Pty Ltd, the current sponsor. | Import and supply | Prescription medicines | |
| Lenvatinib (LENVIMA) capsules 10 mg in blister pack | Eisai Australia Pty Ltd | 233426 | Batch 113691B 10 mg capsule 44 pack | CON-70 | The consent is effective from the 21 June 2016 until the exhaustion of supply of the affected batches. | 21/06/2016 | subclause 3(2)(j) and 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The labels refer to a European sponsor and have distinct storage conditions. | The labels to which this consent applies are the UK carton and blister foil labels %23160;provided in%23160;the letter of application. The carton labels are over-stickered with the relevant over-sticker labels provided in the letter of application and the Australian CMI for the product is attached to the packaging as described in%23160;the letter. | Import and supply | Prescription medicines |
| Lenvatinib (LENVIMA) capsules 4 mg in blister pack | Eisai Australia Pty Ltd | 233425 | Batch 113687B 4 mg capsule 101 packs | CON-70 | The consent is effective from the 21 June 2016 until the exhaustion of supply of the affected batches. | 21/06/2016 | subclause 3(2)(j) and 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The labels refer to a European sponsor and have distinct storage conditions. | The labels to which this consent applies are the UK carton and blister foil labels %23160;provided in%23160;the letter of application. The carton labels are over-stickered with the relevant over-sticker labels provided in the letter of application and the Australian CMI for the product is attached to the packaging as described in%23160;the letter. | Import and supply | Prescription medicines |
| daptomycin (CUBICIN) 500 mg powder for injection vial | Novartis Pharmaceuticals Australia Pty Ltd | 143586 | CON-71 | The consent is effective from the 22 June 2016, but only after transfer of sponsorship from Novartis Pharmaceuticals to Merck Sharpe Dohme has occurred, until the end of June 2017. This consent is only operational if the transfer of sponsorship of the products to Merck Sharpe Dohme referred to in the application occurs. If it does not occur, or if sponsorship is transferred to a different sponsor, it will not be effective. | 22/06/2016 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The sponsor details on the labels are those of the Novartis Pharmaceuticals Australia Pty Ltd (the current sponsor) instead of Merck Sharp amp; Dohme Australia Pty Ltd the new sponsor after transfer of sponsorship. | The labels to which this consent applies are those provided with the application. Procedures are in place for the prompt referral of queries or complaints concerning the products to the new sponsor Merck Sharp amp; Dohme. %23160; | Supply | Prescription medicines | |
| daptomycin (CUBICIN) 350 mg powder for injection vial | Novartis Pharmaceuticals Australia Pty Ltd | 143574 | CON-71 | The consent is effective from the 22 June 2016, but only after transfer of sponsorship from Novartis Pharmaceuticals to Merck Sharpe Dohme has occurred, until the end of June 2017. This consent is only operational if the transfer of sponsorship of the products to Merck Sharpe Dohme referred to in the application occurs. If it does not occur, or if sponsorship is transferred to a different sponsor, it will not be effective. | 22/06/2016 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The sponsor details on the labels are those of the Novartis Pharmaceuticals Australia Pty Ltd (the current sponsor) instead of Merck Sharp amp; Dohme Australia Pty Ltd the new sponsor after transfer of sponsorship. | The labels to which this consent applies are those provided with the application. Procedures are in place for the prompt referral of queries or complaints concerning the products to the new sponsor Merck Sharp amp; Dohme. %23160; | Supply | Prescription medicines | |
| salicylic acid (SCHOLL WART REMOVAL SYSTEM WASHPROOF) 400 mg/g medicated dressing sachet | Reckitt Benckiser Pty Ltd | 53606 | CON-73 | The consent is effective from 27 June 2016 until 31 March 2017. | 27/06/2016 | subclause 3(2)(i) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The labels for the products do not include the name and address details of the current sponsor (instead they include the name and address of the previous sponsor SSL Australia Pty Ltd). | Import and supply | Over-the-counter medicines | ||
| salicylic acid (SCHOLL CORN REMOVAL PLASTERS WASHPROOF) 400 mg/g dressing medicated sachet | Reckitt Benckiser Pty Ltd | 46407 | CON-73 | The consent is effective from 27 June 2016 until 31 March 2017. | 27/06/2016 | subclause 3(2)(i) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The labels for the products do not include the name and address details of the current sponsor (instead they include the name and address of the previous sponsor SSL Australia Pty Ltd). | Import and supply | Over-the-counter medicines | ||
| salicylic acid (SCHOLL CORN REMOVAL PADS) 400 mg/g dressing medicated sachet | Reckitt Benckiser Pty Ltd | 13518 | CON-73 | The consent is effective from 27 June 2016 until 31 March 2017. | 27/06/2016 | subclause 3(2)(i) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The labels for the products do not include the name and address details of the current sponsor (instead they include the name and address of the previous sponsor SSL Australia Pty Ltd). | Import and supply | Over-the-counter medicines | ||
| salicylic acid (SCHOLL CALLUS REMOVAL PADS) 400 mg/g dressing medicated sachet | Reckitt Benckiser Pty Ltd | 13517 | CON-73 | The consent is effective from 27 June 2016 until 31 March 2017. | 27/06/2016 | subclause 3(2)(i) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The labels for the products do not include the name and address details of the current sponsor (instead they include the name and address of the previous sponsor SSL Australia Pty Ltd). | Import and supply | Over-the-counter medicines | ||
| ezetimibe 10 mg+20 mg 10 mg tablets and rosuvastatin (as calcium) (ROSUZET) 20 mg tablets composite pack | Merck Sharp Dohme (Australia) Pty Ltd | 203692 | CON-72 | The consent is effective from 27 June 2016 until 31 December 2016. | 27/06/2016 | subclauses 3(2)(h) and 3(2)(i) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The batch number and expiry date of the products are not preceded by the appropriate prefixes on the blister foil. | The blister foil label to which this consent applies is that provided with the application. The intermediate wallet packaging and carton packaging are labelled with the product batch number and expiry date and appropriate prefixes. | Supply | Prescription medicines | |
| ezetimibe 10 mg + 5 mg 10 mg tablets and rosuvastatin (as calcium) (ROSUZET) 5 mg tablets composite pack | Merck Sharp Dohme (Australia) Pty Ltd | 203690 | CON-72 | The consent is effective from 27 June 2016 until 31 December 2016. | 27/06/2016 | subclauses 3(2)(h) and 3(2)(i) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The batch number and expiry date of the products are not preceded by the appropriate prefixes on the blister foil. | The blister foil label to which this consent applies is that provided with the application. The intermediate wallet packaging and carton packaging are labelled with the product batch number and expiry date and appropriate prefixes. | Supply | Prescription medicines | |
| buprenorphine (as hydrochloride) 8 mg / naloxone (as hydrochloride) 2 mg (SUBOXONE SUBLINGUAL FILM 8/2) soluble film sachet. | Indivior Pty Ltd | 163444 | A16HH109, A16HH209, C16HH101, J15HH112 J15HH114 (Suboxone Sublingual Film 8/2) | CON-74 | The consent is effective from 1 July 2016 until the exhaustion of supply of the specified batches of the products. | 1/07/2016 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69). | The products do not comply with subclause%23160;%23160;%23160;%23160;%23160; 3(2)(l) of TGO 69 in that the labels include the name and address of the previous sponsor. %23160; | The labels to which this consent applies are those previously approved for the former sponsor, Reckitt Benckiser Australia Pty Ltd, and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Indivior Pty Ltd. | Supply | Prescription medicines |
| buprenorphine (as hydrochloride) 2 mg / naloxone (as hydrochloride) 0.5 mg (SUBOXONE SUBLINGUAL FILM 2/0.5) soluble film sachet. | Indivior Pty Ltd | 163443 | B16HJ101, B16HJ102, C16HJ101, K15HJ102 K15HJ103 (Suboxone Sublingual Film 2/0.5) | CON-74 | The consent is effective from 1 July 2016 until the exhaustion of supply of the specified batches of the products. | 1/07/2016 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69). | The products do not comply with subclause%23160;%23160;%23160;%23160;%23160; 3(2)(l) of TGO 69 in that the labels include the name and address of the previous sponsor. %23160; | The labels to which this consent applies are those previously approved for the former sponsor, Reckitt Benckiser Australia Pty Ltd, and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Indivior Pty Ltd. | Supply | Prescription medicines |
| QUADRACEL 0.5 mL injection vial | Sanofi Pasteur Australia Pty Ltd | 91355 | Lot C5146B | CON-75 | The consent is effective from 4 July 2016 until the expiry of Lot C5146B on 2 September 2018. | 4/07/2016 | European Pharmacopoeia | The product is tested to United States, rather than Australian specifications. | This consent applies only to 24000 doses from Quadracel final bulk Lot C5146B (expiry on 2 September 2018); Non-compliance with the European Pharmacopoeia (Ph. Eur.) requirements is limited to the tests detailed in the application; The doses will be labelled in the Australian approved labels (carton, vial and package insert); The company will provide TGA with a copy of the Release Certificate of the above batch from US CBER; Normal TGA lot release processes will apply to this batch. %23160; | Import and supply | Prescription medicines |
| montelukast (as sodium) (CIPLA MONTELUKAST 10) 10 mg film-coated tablet blister pack | Biotech Regulatory Solutions Pty Ltd | 230556 | CON-76 | The consent is effective from the 20 July 2016 until the BP comes into effect. | 20/07/2016 | British Pharmacopoeia (BP) 2016 monographs for chewable Montelukast Tablets and Montelukast Tablets. | The products do not comply with the requirement for 'Impurity B'. | Import and supply | Prescription medicines | ||
| montelukast (as sodium) (CIPLA MONTELUKAST 5) 5 mg chewable tablet pack blister pack | Biotech Regulatory Solutions Pty Ltd | 230555 | CON-76 | The consent is effective from the 20 July 2016 until the BP comes into effect. | 20/07/2016 | British Pharmacopoeia (BP) 2016 monographs for chewable Montelukast Tablets and Montelukast Tablets. | The products do not comply with the requirement for 'Impurity B'. | Import and supply | Prescription medicines | ||
| montelukast (as sodium) (CIPLA MONTELUKAST 4) 4 mg chewable tablet blister pack | Biotech Regulatory Solutions Pty Ltd | 230554 | CON-76 | The consent is effective from the 20 July 2016 until the BP comes into effect. | 20/07/2016 | British Pharmacopoeia (BP) 2016 monographs for chewable Montelukast Tablets and Montelukast Tablets. | The products do not comply with the requirement for 'Impurity B'. | Import and supply | Prescription medicines | ||
| adalimumab (rch) 40 mg (HUMIRA) solution for injection pre-filled syringe | AbbiVie Pty Ltd | 199412 | CON-77 | The consent is effective from the 26 July 2016 until 1 September 2017. | 26/07/2016 | subclause 3(2)(l) of Therapeutic Goods Order No. 69- General requirements for labels for medicines. | in that the%23160;products' labels contain the sponsor's previous address 32-34 Lord St, Botany, NSW 2019. | That the labels to be supplied are those which contain the previous address (32-34 Lord St, Botany, NSW 2019) of the sponsor. Arrangements are in place for the forwarding of material sent to the previous Botany address to the current sponsor address. Services such as medical information, customer enquiries, pharmacovigilance activities and customer complaints will continue to be provided, and contingencies will be put in place to ensure any communications with the previous address will be forwarded to the new address. The company will ensure that updated labels with the sponsor's current address will be implemented as soon as possible, preferably within the exemption period. | Import and supply | Blood, tissues, and biologicals | |
| adalimumab (rch) 40 mg (HUMIRA) solution for injection pre-filled pen | AbbiVie Pty Ltd | 199410 | CON-77 | The consent is effective from the 26 July 2016 until 1 September 2017. | 26/07/2016 | subclause 3(2)(l) of Therapeutic Goods Order No. 69- General requirements for labels for medicines. | in that the%23160;products' labels contain the sponsor's previous address 32-34 Lord St, Botany, NSW 2019. | That the labels to be supplied are those which contain the previous address (32-34 Lord St, Botany, NSW 2019) of the sponsor. Arrangements are in place for the forwarding of material sent to the previous Botany address to the current sponsor address. Services such as medical information, customer enquiries, pharmacovigilance activities and customer complaints will continue to be provided, and contingencies will be put in place to ensure any communications with the previous address will be forwarded to the new address. The company will ensure that updated labels with the sponsor's current address will be implemented as soon as possible, preferably within the exemption period. | Import and supply | Blood, tissues, and biologicals | |
| adalimumab (rch) 20 mg (HUMIRA) solution for injection pre-filled syringe | AbbiVie Pty Ltd | 199411 | CON-77 | The consent is effective from the 26 July 2016 until 1 September 2017. | 26/07/2016 | subclause 3(2)(l) of Therapeutic Goods Order No. 69- General requirements for labels for medicines. | in that the%23160;products' labels contain the sponsor's previous address 32-34 Lord St, Botany, NSW 2019. | That the labels to be supplied are those which contain the previous address (32-34 Lord St, Botany, NSW 2019) of the sponsor. Arrangements are in place for the forwarding of material sent to the previous Botany address to the current sponsor address. Services such as medical information, customer enquiries, pharmacovigilance activities and customer complaints will continue to be provided, and contingencies will be put in place to ensure any communications with the previous address will be forwarded to the new address. The company will ensure that updated labels with the sponsor's current address will be implemented as soon as possible, preferably within the exemption period. | Import and supply | Blood, tissues, and biologicals | |
| glipizide (GLIPIDIAB) 5 mg Tablets blister pack | Pfizer Australia Pty Ltd | 170384 | CON-78 | The consent is effective from 11 August 2016 to 31 August 2018. | 11/08/2016 | Therapeutic Goods Order No. 78 ‘Standard for tablets and Capsules’ | The products do not comply with Section 8 of the Order in that the finished product specifications do not meet the requirements of the current British Pharmacopoeia (BP) monograph for Glipizide Tablets with respect to content of Impurity A. | The release and expiry limits applied to Impurity A of the BP monograph for Glipizide Tablets for content of Impurity A in the finished product specifications are those detailed in the submission dated 13 April 2016. | Import and supply | Prescription medicines | |
| glipizide (MINIDIAB) 5 mg tablet blister pack | Pfizer Australia Pty Ltd | 15421 | CON-78 | The consent is effective from 11 August 2016 to 31 August 2018. | 11/08/2016 | Therapeutic Goods Order No. 78 ‘Standard for tablets and Capsules’ | The products do not comply with Section 8 of the Order in that the finished product specifications do not meet the requirements of the current British Pharmacopoeia (BP) monograph for Glipizide Tablets with respect to content of Impurity A. | The release and expiry limits applied to Impurity A of the BP monograph for Glipizide Tablets for content of Impurity A in the finished product specifications are those detailed in the submission dated 13 April 2016. | Import and supply | Prescription medicines | |
| Swisse Men's Ultivite | Swisse Wellness Pty Ltd | 218375 | 21503719/01, 21503719/02, 21503719/03, 21503719/04 21503719/05, 21503719/06, 21503719/07, 21503719/08, 21504038/01, 21504038/02, 21504038/03 | CON-80 | The consent is effective from 17 August 2016 until 20 August 2018. | 17/08/2016 | subclause 10(b) of the Therapeutic Goods Order No.78 – Standard for Tablets and Capsules | The product does not comply with the upper content limit of 125.0% of the stated content on the label for copper. | The content of copper must be no less than 90.0% and no more than 142.0% of the stated content on the label. | Import, supply and export | Listed complementary medicines |
| calcium (STAY SAFE BALANCE) 2.3% glucose 1.25 mmol/L peritoneal dialysis solution bag | Fresenius Medical Care Australia Pty Ltd | 92956 | CON-79 | The consent is effective from 17 August 2016 until 16 August 2018. | 17/08/2016 | subclauses 3(2)(b) and 3(8)(f) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | not all of the ingredient names on the labels are expressed as Australian Approved Names (AANs) and the labels do not bear the statement 'Use in one patient on one occasion only. Contains no antimicrobial preservative'. | The labels to which this consent applies are the ones provided with the Category 3 application letter (Submission No. PM-2016-02135-1-5) dated 14 June 2016. | Import and supply | Prescription medicines | |
| calcium (STAY SAFE BALANCE) 1.5% glucose 1.25 mmol/L peritoneal dialysis solution bag | Fresenius Medical Care Australia Pty Ltd | 92945 | CON-79 | The consent is effective from 17 August 2016 until 16 August 2018. | 17/08/2016 | subclauses 3(2)(b) and 3(8)(f) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | not all of the ingredient names on the labels are expressed as Australian Approved Names (AANs) and the labels do not bear the statement 'Use in one patient on one occasion only. Contains no antimicrobial preservative'. | The labels to which this consent applies are the ones provided with the Category 3 application letter (Submission No. PM-2016-02135-1-5) dated 14 June 2016. | Import and supply | Prescription medicines | |
| Buprenorphine (as hydrochloride) (TEMGESIC) injection 0.3 mg in 1 mL ampoule | Indivior Pty Ltd | 15394 | CON-81 | The consent is effective from the 24 August 2016 until 31 March 2017. | 24/08/2016 | sub-clause 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The products do not conform because the labels do not include the current sponsor's name and address. | The labels to which this consent applies are those previously approved for the former sponsor Reckitt Benckiser Australia Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Indivior Pty Ltd [the current sponsor]. | Supply | Prescription medicines | |
| Buprenorphine (as hydrochloride) (SUBUTEX/TEMGESIC) sublingual tablets 8 mg | Indivior Pty Ltd | 76663 | CON-81 | The consent is effective from the 24 August 2016 until 31 March 2017. | 24/08/2016 | sub-clause 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The products do not conform because the labels do not include the current sponsor's name and address. | The labels to which this consent applies are those previously approved for the former sponsor Reckitt Benckiser Australia Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Indivior Pty Ltd [the current sponsor]. | Supply | Prescription medicines | |
| Buprenorphine (as hydrochloride) (SUBUTEX/TEMGESIC) sublingual tablets 2 mg | Indivior Pty Ltd | 76662 | CON-81 | The consent is effective from the 24 August 2016 until 31 March 2017. | 24/08/2016 | sub-clause 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The products do not conform because the labels do not include the current sponsor's name and address. | The labels to which this consent applies are those previously approved for the former sponsor Reckitt Benckiser Australia Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Indivior Pty Ltd [the current sponsor]. | Supply | Prescription medicines | |
| Buprenorphine (as hydrochloride) (SUBUTEX/TEMGESIC) sublingual tablets 0.4 mg | Indivior Pty Ltd | 76661 | CON-81 | The consent is effective from the 24 August 2016 until 31 March 2017. | 24/08/2016 | sub-clause 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The products do not conform because the labels do not include the current sponsor's name and address. | The labels to which this consent applies are those previously approved for the former sponsor Reckitt Benckiser Australia Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Indivior Pty Ltd [the current sponsor]. | Supply | Prescription medicines | |
| Buprenorphine (as hydrochloride) (SUBUTEX/TEMGESIC) sublingual tablets 0.2 mg | Indivior Pty Ltd | 34091 | CON-81 | The consent is effective from the 24 August 2016 until 31 March 2017. | 24/08/2016 | sub-clause 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The products do not conform because the labels do not include the current sponsor's name and address. | The labels to which this consent applies are those previously approved for the former sponsor Reckitt Benckiser Australia Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Indivior Pty Ltd [the current sponsor]. | Supply | Prescription medicines | |
| Ritonavir (NORVIR) 100 mg tablet bottle | Abbvie Pty Ltd | 158301 | CON-82 | The consent is effective from the 1 September 2016 until 28 February 2017. | 29/08/2016 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | the previous sponsor address '32-34 Lord Street, Botany 2019 Australia' is included on the product labels rather than the current sponsor address '241 O'Riordan Street Mascot NSW 2020 Australia'. | The KALETRA carton and bottle labels to which this consent applies are the ones labelled as 'current labels' provided with the current sponsor's letter of application dated 2 August 2016; and The NORVIR carton and bottle labels to which this consent applies are the ones labelled as 'current labels' provided with%23160;the current sponsor's%23160;letter of application dated 1 August 2016. | Import and supply | Prescription medicines | |
| Lopinavir (KALETRA) 80 mg/mL and ritonavir 20 mg/mL oral solution | Abbvie Pty Ltd | 78627 | CON-82 | The consent is effective from the 1 September 2016 until 28 February 2017. | 29/08/2016 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | the previous sponsor address '32-34 Lord Street, Botany 2019 Australia' is included on the product labels rather than the current sponsor address '241 O'Riordan Street Mascot NSW 2020 Australia'. | The KALETRA carton and bottle labels to which this consent applies are the ones labelled as 'current labels' provided with the current sponsor's letter of application dated 2 August 2016; and The NORVIR carton and bottle labels to which this consent applies are the ones labelled as 'current labels' provided with%23160;the current sponsor's%23160;letter of application dated 1 August 2016. | Import and supply | Prescription medicines | |
| Lopinavir (KALETRA) 100 mg and ritonavir 25 mg tablets bottle | Abbvie Pty Ltd | 140509 | CON-82 | The consent is effective from the 1 September 2016 until 28 February 2017. | 29/08/2016 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | the previous sponsor address '32-34 Lord Street, Botany 2019 Australia' is included on the product labels rather than the current sponsor address '241 O'Riordan Street Mascot NSW 2020 Australia'. | The KALETRA carton and bottle labels to which this consent applies are the ones labelled as 'current labels' provided with the current sponsor's letter of application dated 2 August 2016; and The NORVIR carton and bottle labels to which this consent applies are the ones labelled as 'current labels' provided with%23160;the current sponsor's%23160;letter of application dated 1 August 2016. | Import and supply | Prescription medicines | |
| lopinavir (KALETRA) 200 mg and ritonavir 50 mg tablets bottle | Abbvie Pty Ltd | 121055 | CON-83 | The consent is effective from the 1 September 2016 until 28 February 2017. | 1/09/2016 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The previous sponsor address '32-34 Lord Street, Botany 2019 Australia' is included on the product labels rather than the current sponsor address '241 O'Riordan Street Mascot NSW 2020 Australia'. | The KALETRA carton and bottle labels to which this consent applies are those labelled as 'current labels' provided with%23160;the sponsor's%23160;letter of application dated 30 August 2016. | Import and supply | Prescription medicines | |
| Levetiracetam (LEVETIRACETAM SZ) tablet 250 mg in blister pack | Southern Cross Pharma Pty Ltd | 159268 | Batch L160406 250 mg tablet | CON-84 | The consent is effective from the 7 September 2016 until the exhaustion of the supply of the batches of product specified above. | 7/09/2016 | sub-clauses 3(2)(h) and 3(2)(i) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The blister foil labels do not include the batch number and expiry date prefixes. | The 'Dear Healthcare Professional/Pharmacist' letter (dated 12 August 2016) identical to that provided to the TGA in%23160;the sponsor's%23160;application will be supplied with each affected batch of the product. The blister foil labels to which this consent applies are those provided in%23160;the sponsor's application. | Supply | Prescription medicines |
| Levetiracetam (LEVETIRACETAM SZ) tablet 500 mg in blister pack | Southern Cross Pharma Pty Ltd | 159269 | Batch L160657 500 mg tablet | CON-84 | The consent is effective from the 7 September 2016 until the exhaustion of the supply of the batches of product specified above. | 7/09/2016 | sub-clauses 3(2)(h) and 3(2)(i) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The blister foil labels do not include the batch number and expiry date prefixes. | The 'Dear Healthcare Professional/Pharmacist' letter (dated 12 August 2016) identical to that provided to the TGA in%23160;the sponsor's%23160;application will be supplied with each affected batch of the product. The blister foil labels to which this consent applies are those provided in%23160;the sponsor's application. | Supply | Prescription medicines |
| Levetiracetam (LEVETIRACETAM SZ) tablet 1000 mg in blister pack | Southern Cross Pharma Pty Ltd | 159271 | Batch L160661 1000 mg tablet | CON-84 | The consent is effective from the 7 September 2016 until the exhaustion of the supply of the batches of product specified above. | 7/09/2016 | sub-clauses 3(2)(h) and 3(2)(i) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The blister foil labels do not include the batch number and expiry date prefixes. | The 'Dear Healthcare Professional/Pharmacist' letter (dated 12 August 2016) identical to that provided to the TGA in%23160;the sponsor's%23160;application will be supplied with each affected batch of the product. The blister foil labels to which this consent applies are those provided in%23160;the sponsor's application. | Supply | Prescription medicines |
| hexaminolevulinate (as hydrochloride) (HEXVIX) 85 mg powder for intravesical solution plus diluent | Juno Pharmaceuticals Pty Ltd | 259252 | CON-85 | The consent is effective from the 08 September 2016 until 07 September 2017. | 8/09/2016 | subsections 3(1)(a), 3(2)(g) and 3(2)(j) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels are not in English, do not bear warning statements and do not include the approved storage condition. | A 'Dear Doctor' letter identical to that provided to the TGA on 5 September 2016%23160;will be supplied to clinicians using the affected stock stating that it is qualitatively and quantitatively identical to HEXVIX registered on the ARTG, other than the labelling; A copy of the Australian approved product information (version 39.HX.P.1.10) will be supplied with the affected stock; and The HEXVIX carton label, vial label and diluent vial label to which this consent applies are the ones provided via email dated 31 August 2016 and will be overstickered with the Australian sponsor's details and the AUST R number as agreed in%23160;the sponsor's%23160;email dated 31 August 2016. | Supply | Prescription medicines | |
| promethazine hydrochloride (SANDOZ FENEZAL) 25 mg tablet | Sanofi-Aventis Australia Pty Ltd | 134532 | CON-86 | The consent is effective from the 12 September 2016 until 31 July 2017. | 12/09/2016 | The Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The product labels display the old address of the sponsor. | Import and supply | Over-the-counter medicines | ||
| promethazine hydrochloride (SANDOZ FENEZAL) 10 mg tablet | Sanofi-Aventis Australia Pty Ltd | 134531 | CON-86 | The consent is effective from the 12 September 2016 until 31 July 2017. | 12/09/2016 | The Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The product labels display the old address of the sponsor. | Import and supply | Over-the-counter medicines | ||
| ULTRATAG RBC injection composite pack | Landauer Radiopharmaceuticals Pty Ltd | 47860 | CON-87 | The consent is effective from the 13 September 2016 until 13 February 2017. | 13/09/2016 | subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels bear the previous sponsor's name and address. | The labels to which this consent applies are the ones labelled as 'currently approved labels' provided with the previous Section 14 consent application letter dated 5 August 2015 (Submission No.%2358; PM-2015-02901-1-2); and Arrangements are%23160;place for all queries to be directed to Landauer Radiopharmaceuticals Pty Ltd [the current sponsor]. %23160; | Supply | Prescription medicines | |
| pirfenidone (ESBRIET) 267 mg hard capsule bottle | Roche Products Pty Ltd | 235577 | CON-88 | The consent is effective 15 September 2016 until 14 September 2017. | 15/09/2016 | subclauses 3(2)(a) and (g) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The product label does not state the product name or the appropriate warning statements. | The labels to which this consent applies are those provided with%23160;the%23160;letter of application and which include an over-sticker that details the AUST R number; and Supply of the affected batches will be to practitioners already familiar with the above mentioned labels. %23160; | Supply | Prescription medicines | |
| erythromycin (as ethyl succinate) (EES) 400 mg/5 mL granules for oral liquid bottle | BNM Group | 54456 | CON-89 | The consent is effective from 30 September 2016 until: 30 November 2016 (Product: HYGROTON 25 chlortalidone 25mg tablet bottle; ARTG: 11035) 31 December 2016 (Product: ERYTHROCIN IV erythromycin 1g (as lactobionate) powder for injection vial; ARTG: 131444) 30 June 2017 (EES erythromycin (as ethyl succinate) 400mg/5mL granules for oral liquid bottle; ARTG: 54456). | 19/09/2016 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The product labels state the former Sponsor's name and contact details. | The labels to which this consent applies are those previously approved for the former sponsor Link Medical Products Pty Ltd%23160;(Link) and arrangements are in place with the former sponsor Link for the prompt referral of any queries or complaints concerning the products to Amdipharm Mercury Australia Pty Ltd (the current sponsor). %23160; | Import and supply | Prescription medicines | |
| erythromycin 1 g (as lactobionate) (ERYTHROCIN IV) powder for injection vial | BNM Group | 131444 | CON-89 | The consent is effective from 30 September 2016 until: 30 November 2016 (Product: HYGROTON 25 chlortalidone 25mg tablet bottle; ARTG: 11035) 31 December 2016 (Product: ERYTHROCIN IV erythromycin 1g (as lactobionate) powder for injection vial; ARTG: 131444) 30 June 2017 (EES erythromycin (as ethyl succinate) 400mg/5mL granules for oral liquid bottle; ARTG: 54456). | 19/09/2016 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The product labels state the former Sponsor's name and contact details. | The labels to which this consent applies are those previously approved for the former sponsor Link Medical Products Pty Ltd%23160;(Link) and arrangements are in place with the former sponsor Link for the prompt referral of any queries or complaints concerning the products to Amdipharm Mercury Australia Pty Ltd (the current sponsor). %23160; | Import and supply | Prescription medicines | |
| chlortalidone (HYGROTON 25) 25 mg tablet bottle | BNM Group | 11035 | CON-89 | The consent is effective from 30 September 2016 until: 30 November 2016 (Product: HYGROTON 25 chlortalidone 25mg tablet bottle; ARTG: 11035) 31 December 2016 (Product: ERYTHROCIN IV erythromycin 1g (as lactobionate) powder for injection vial; ARTG: 131444) 30 June 2017 (EES erythromycin (as ethyl succinate) 400mg/5mL granules for oral liquid bottle; ARTG: 54456). | 19/09/2016 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The product labels state the former Sponsor's name and contact details. | The labels to which this consent applies are those previously approved for the former sponsor Link Medical Products Pty Ltd%23160;(Link) and arrangements are in place with the former sponsor Link for the prompt referral of any queries or complaints concerning the products to Amdipharm Mercury Australia Pty Ltd (the current sponsor). %23160; | Import and supply | Prescription medicines | |
| cetirizine hydrochloride (IPCA CETIRIZINE) 10 mg film coated tablet blister pack | Ipca Pharma (Australia) Pty Ltd | 169953 | CON-90 | The consent is effective from the 20 September 2016 until the 31st December 2019. | 20/09/2016 | The products do not conform with the requirements of the Therapeutic Goods Order No. 78 ‘Standard for tablets and Capsules’ in respect of Section 8. | The finished product specifications do not meet the requirements of the current British Pharmacopoeia (BP) monograph for Cetirizine Tablets with respect to 'the area of any other secondary peak' in the test for Related Substances. | The release and expiry limits applied to the 'lactose-ester' impurity in the finished product specifications are those detailed in the request dated 19 May 2016; consistent with the relevant requirements of the United States Pharmacopeia monograph for Cetirizine Hydrochloride Tablets. %23160; | Import, supply and export | Over-the-counter medicines | |
| cetirizine hydrochloride (ZETRINE) 10 mg film coated tablet blister pack | Ipca Pharma (Australia) Pty Ltd | 126152 | CON-90 | The consent is effective from the 20 September 2016 until the 31st December 2019. | 20/09/2016 | The products do not conform with the requirements of the Therapeutic Goods Order No. 78 ‘Standard for tablets and Capsules’ in respect of Section 8. | The finished product specifications do not meet the requirements of the current British Pharmacopoeia (BP) monograph for Cetirizine Tablets with respect to 'the area of any other secondary peak' in the test for Related Substances. | The release and expiry limits applied to the 'lactose-ester' impurity in the finished product specifications are those detailed in the request dated 19 May 2016; consistent with the relevant requirements of the United States Pharmacopeia monograph for Cetirizine Hydrochloride Tablets. %23160; | Import, supply and export | Over-the-counter medicines | |
| SOOTHERS LIQUID CENTRES – Lemon Lime | Nestle Australia Ltd | 227151 | CON-92 | The consent is effective from the 22 September 2016 until 22 September 2018. | 22/09/2016 | subclause 3(12)(a) for ‘individually wrapped goods’ of the Therapeutic Goods Order No. 69– General requirements for labels for medicines. | The name and quantity of all active ingredients in the goods do not appear on each individual unsealed wrapper (subclause 3(12)(b)). %23160; | The individual lozenges which are individually wrapped in an unsealed, protective cover are enclosed in a primary pack%23160; that includes the particulars referred to in subclauses 3(2) and 3(3) of the TGO 69. | Supply | Listed complementary medicines | |
| SOOTHERS BLACKCURRANT | Nestle Australia Ltd | 278595 | CON-91 | The consent is effective from the 22 September 2016 until 22 September 2018. | 22/09/2016 | subclause 3(12)(a) for ‘individually wrapped goods’ of the Therapeutic Goods Order No. 69– General requirements for labels for medicines. | The name and quantity of all active ingredients in the goods do not appear on each individual unsealed wrapper (subclause 3(12)(b)).%23160;%23160; | The individual lozenges which are individually wrapped in an unsealed, protective cover are enclosed in a primary pack%23160;that includes the particulars referred to in subclauses 3(2) and 3(3) of the TGO 69. | Supply | Listed complementary medicines | |
| Cetirizine hydrochloride (PRICELINE CETIRIZINE) 10mg tablet blister pack | Dr Reddys Laboratories Australia Pty Ltd | 157094 | CON-93 | The consent is effective from the 27 September 2016 until the 31st of December 2019. | 27/09/2016 | The requirements of the Therapeutic Goods Order No. 78 ‘Standard for tablets and Capsules’ in respect of Section 8. | Finished product specifications do not meet the requirements of the current British Pharmacopoeia (BP) monograph for Cetirizine Tablets with respect to the 'area of any other secondary peak' in the test for Related Substances. | The release and expiry limits applied to the lactose-ester impurity in the finished products specifications are those detailed in the request dated 19 May 2016; consistent with the relevant requirements of the United States Pharmacopeia monograph for Cetirizine Hydrochloride Tablets. | Import, supply and export | Over-the-counter medicines | |
| Cetirizine hydrochloride (PHARMACY HEALTH CETIRIZINE) 10mg film coated tablet blister pack | Dr Reddys Laboratories Australia Pty Ltd | 156885 | CON-93 | The consent is effective from the 27 September 2016 until the 31st of December 2019. | 27/09/2016 | The requirements of the Therapeutic Goods Order No. 78 ‘Standard for tablets and Capsules’ in respect of Section 8. | Finished product specifications do not meet the requirements of the current British Pharmacopoeia (BP) monograph for Cetirizine Tablets with respect to the 'area of any other secondary peak' in the test for Related Substances. | The release and expiry limits applied to the lactose-ester impurity in the finished products specifications are those detailed in the request dated 19 May 2016; consistent with the relevant requirements of the United States Pharmacopeia monograph for Cetirizine Hydrochloride Tablets. | Import, supply and export | Over-the-counter medicines | |
| Levetiracetam (LEVETIRACETAM SZ) tablet 500 mg in blister pack | Southern Cross Pharma Pty Ltd | 159269 | Batch L1606571 | CON-95 | The consent is effective from the 30 September 2016 until the exhaustion of the supply of batch L1606571 of the product. | 30/09/2016 | sub-clauses 3(2)(h) and 3(2)(i) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The blister foil labels do not include the batch number and expiry date prefixes. | The 'Dear Healthcare Professional/Pharmacist' letter (dated 8 September 2016) identical to that provided to the TGA in the application will be supplied with the affected batch of the product. | Supply | Prescription medicines |
| cilostazol (PLETAL) 100 mg tablet blister pack | Otsuka Australia Pharmaceutical Pty Ltd | 140599 | CON-96 | The consent is effective from the 6 October 2016 until 5 April 2018. | 6/10/2016 | subclauses 3(2)(g) and 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The over-stickered carton label does not bear warning statement(s) and current sponsor name and address. | The labels (i.e. UK carton and blister foil labels and Australian over-sticker) to which this consent applies are those previously approved for the former sponsor Aspen Pharma Pty Ltd and arrangements are in place with the former sponsor Aspen Pharma Pty Ltd for the prompt referral of any queries or complaints concerning this product to the Otsuka Australia Pharmaceutical Pty Ltd (the current sponsor); and A 'Dear Pharmacist' letter identical to that provided to the TGA on 5 October 2016%23160;will be provided with the affected stock advising the pharmacist to provide the patients with a copy of the CMI at the time of dispensing and also advise the patients of the appropriate website because that stated on the carton over-sticker is no longer active. | Import and supply | Prescription medicines | |
| aciclovir (CHEMISTS’ OWN COLD SORE CREAM) 5 % w/w tube | Arrow Pharma Pty Ltd | 106588 | CON-97 | The consent is effective from the 10 October 2016 until 31 August 2018. | 10/10/2016 | The product does not conform to the requirements of section 8 of the Therapeutic Goods Order No. 77– Microbiological Standards for Medicines. | The product does not comply with the acceptance criteria specified in the British Pharmacopoeia Test for Efficacy of Antimicrobial Preservation for Aspergillus brasiliensis. | The product must meet the acceptance criteria for Aspergillus brasiliensis specified in the USP General Chapter lt;51gt; Antimicrobial Effectiveness Testing. | Supply | Over-the-counter medicines | |
| lumacaftor/ivacaftor (ORKAMBI 200/125) 200 mg/125 mg film-coated tablet blister pack. | Tudorrose Consulting Pty Ltd | 235759 | CON-98 | The consent is effective from the 12 October 2016 until 31 December 2016. | 12/10/2016 | subclauses 3(2)(a) and (j) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The product labels do not include the product name and storage conditions. | The labels are the same as those supplied under the previous s14 consent TGA%23160;ref%2358;%23160;(R16/239848) and is over-stickered with the AUST R number. | Import and supply | Prescription medicines | |
| foscarnet sodium (FOSCAVIR) 6 g/250 mL injection bottle | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | 37310 | 16GK0280, 16IK2520 and 16KE4319 | CON-99 | The consent is effective from the 25 October 2016 until 31 March 2017. | 25/10/2016 | subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product carton and bottle labels bear the former sponsor's name and address. | The labels to which this consent applies are those previously approved on 19 March 2012 (PM-2012-00831-3-2) for the former sponsor, Clinect Pty Ltd, and arrangements are in place with the former sponsor for all queries or complaints concerning the product to be forwarded to Link Medical Products Pty Ltd (the current sponsor). | Import and supply | Prescription medicines |
| IZBA travoprost 30 microgram/mL eye drops solution bottle | Alcon Laboratories Australia Pty Ltd | 263496 | CON-129 | The consent is effective from 27 October 2016. | 27/10/2016 | USP monograph ‘Travoprost Opthalmic Solution.’ | pH of the solution. | the exemption applies indefinately and; The pH shelf life limits of 6.4-7.0 for IZBA are approved. | Import and supply | Prescription medicines | |
| rabies virus vaccine (Inactivated) (RABIPUR) 2.5 IU powder for injection vial with diluent ampoule | GlaxoSmithKline Australia Pty Ltd | 100582 | CON-103 | The consent is effective from the 27 October 2016 until 30 November 2017. | 27/10/2016 | Subclause 3(2)(l) of Therapeutics Goods Order No. 69 ” General requirements for labels for medicines. | The product will be supplied in labels containing the name and address of the previous sponsor (CSL Limited, now known as Seqirus), rather than the current sponsor (GlaxoSmithKline Australia Pty Ltd). | The labels to which this consent applies are those previously approved for the former sponsor CSL Limited and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to the current sponsor, GlaxoSmithKline Australia Pty Ltd. | Supply | Prescription medicines | |
| rasagiline mesilate (AZILECT) 1 mg tablet blister pack | Teva Pharma Australia Pty Ltd | 170172 | R90025, R90027 and R90029 | CON-104 | The consent is effective from the 31 October 2016 and is limited to batches R90025, R90027 and R90029 | 31/10/2016 | Sub-clause 3(13)(a) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO No. 69). | The product does not conform to the standard in that the blister foil label does not include the relevant batch number and expiry date prefixes as required by TGO No. 69. | A 'Dear Healthcare Provider/Pharmacist' letter identical to that provided to the TGA with the electronic mail of 28 October 2016 will be supplied with each affected batch alerting patients to the missing prefixes on the blister foil label and advising them to keep the blister inside the carton when not in use. The blister foil labels to which this consent applies are those as currently supplied. | Import and supply | Prescription medicines |
| mirtazapine (MIRTAZON) tablet 45 mg in blister pack | Merck Sharp Dohme (Australia) Pty Ltd | 121869 | CON-102 | The consent is effective from the 2 November 2016 until 30 April 2017. | 2/11/2016 | sub-clause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The carton and blister foil labels do not include the current sponsor's name and contact details. | The previous distributor of the products has agreed for the company to use its labels for the duration stated above and arrangements are in place to forward any enquiries, complaints, and /or report of adverse events immediately to the company upon receipt. The carton and blister foil labels to which this consent applies are those provided in the application. | Import and supply | Prescription medicines | |
| mirtazapine (MIRTAZON) tablet 30 mg in blister pack | Merck Sharp Dohme (Australia) Pty Ltd | 82941 | CON-102 | The consent is effective from the 2 November 2016 until 30 April 2017. | 2/11/2016 | sub-clause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The carton and blister foil labels do not include the current sponsor's name and contact details. | The previous distributor of the products has agreed for the company to use its labels for the duration stated above and arrangements are in place to forward any enquiries, complaints, and /or report of adverse events immediately to the company upon receipt. The carton and blister foil labels to which this consent applies are those provided in the application. | Import and supply | Prescription medicines | |
| ondansetron (ONDANSETRON AN ODT) 4 mg orally disintegrating tablets blister pack | Amneal Pharma Australia Pty Ltd | 196807 | OA0415002-A | CON-105 | The consent is effective from 3 November 2016 until the batches OA0415002-A (4 mg tablet product) and OS0816004-A (8 mg tablet product) are exhausted. | 3/11/2016 | Subclause 3(13)(b) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO No. 69). | %23160;The products' blister packaging label which has an individual segment that can be readily detached, does not have particulars referred to in subclauses 3(2)(a), (b) and (c) appear at least once in every two dosage units. | A 'Dear Healthcare Professional/Pharmacist' letter identical to that provided to the TGA on 3 November 2016 advising them to remind patients to either keep the blister packs with the correctly labelled carton or detach segments in a specific manner to avoid loss of information, must be provided with each of the affected batches. The blister foil labels to which this consent apply are those currently in use. | Import and supply | Prescription medicines |
| ondansetron (ONDANSETRON AN ODT) 8 mg orally disintegrating tablets blister pack | Amneal Pharma Australia Pty Ltd | 196805 | OS0816004-A | CON-105 | The consent is effective from 3 November 2016 until the batches OA0415002-A (4 mg tablet product) and OS0816004-A (8 mg tablet product) are exhausted. | 3/11/2016 | Subclause 3(13)(b) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO No. 69). | %23160;The products' blister packaging label which has an individual segment that can be readily detached, does not have particulars referred to in subclauses 3(2)(a), (b) and (c) appear at least once in every two dosage units. | A 'Dear Healthcare Professional/Pharmacist' letter identical to that provided to the TGA on 3 November 2016 advising them to remind patients to either keep the blister packs with the correctly labelled carton or detach segments in a specific manner to avoid loss of information, must be provided with each of the affected batches. The blister foil labels to which this consent apply are those currently in use. | Import and supply | Prescription medicines |
| aciclovir (NYAL ANTIVIRAL COLD SORE) cream 50 mg/g tube | iNova Pharmaceuticals (Australia) Pty Ltd | 147218 | CON-110 | The consent is effective from 8 November 2016 until 31 August 2018. | 8/11/2016 | The Therapeutic Goods Order No. 77 – Microbiological Standards for Medicines. | Does not comply with the acceptance criteria specified in the British Pharmacopoeia Test for Efficacy of Antimicrobial Preservation for Aspergillus brasiliensis. | The product must meet the acceptance criteria for Aspergillus brasiliensis specified in the USP General Chapter <51> Antimicrobial Effectiveness Testing. | Supply | Over-the-counter medicines | |
| gentamicin implant (SEPTOPAL) | Zimmer Biomet Pty Ltd | 159233 | CON-108 | The consent is effective from 8 November 2016 until 8 November 2017. | 8/11/2016 | The Therapeutic Goods Order (TGO) 69 – General requirements for labels for medicines – subclause 3(2)(l). | The product does not have the name and address of the current sponsor or supplier of the goods. | Arrangements are in place for the prompt referral of all queries or complaints about the product to the new sponsor/address. The labels to be supplied during the period of consent are those currently approved, bearing the details of Biomet Australia Pty Ltd instead of Zimmer Biomet Pty Ltd. | Supply | Prescription medicines | |
| TRIASYN 2.5/2.5 tablet blister pack | Sanofi-Aventis Australia Pty Ltd | 67184 | CON-107 | The consent is effective from 8 November 2016 until 8 November 2018. | 8/11/2016 | Subsection 11(b) of the Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules. | The estimated average content of each active ingredient at expiry may be less than 92.5 per cent of the label claim. | The drug product release and expiry specifications are the same as those currently approved. | Import and supply | Prescription medicines | |
| TRIASYN 5.0/5.0 tablet blister pack | Sanofi-Aventis Australia Pty Ltd | 67183 | CON-107 | The consent is effective from 8 November 2016 until 8 November 2018. | 8/11/2016 | Subsection 11(b) of the Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules. | The estimated average content of each active ingredient at expiry may be less than 92.5 per cent of the label claim. | The drug product release and expiry specifications are the same as those currently approved. | Import and supply | Prescription medicines | |
| aripiprazole (ARIPIPRAZOLE GH) 30 mg tablet blister pack | Generic Health Pty Ltd | 176815 | CON-106 | The consent is effective from 8 November 2016 until 31 August 2017. | 8/11/2016 | The requirements of Part 3-1 – Standards of the Therapeutic Goods Act 1989 (Cth). | The products do not comply with the default standard for the products, i.e. the USP 39 monograph for Aripiprazole Tablets. | The products must continue to meet the currently approved finished product specifications at release and expiry. | Import and supply | Prescription medicines | |
| aripiprazole (ARIPIPRAZOLE GH) 20 mg tablet blister pack | Generic Health Pty Ltd | 176813 | CON-106 | The consent is effective from 8 November 2016 until 31 August 2017. | 8/11/2016 | The requirements of Part 3-1 – Standards of the Therapeutic Goods Act 1989 (Cth). | The products do not comply with the default standard for the products, i.e. the USP 39 monograph for Aripiprazole Tablets. | The products must continue to meet the currently approved finished product specifications at release and expiry. | Import and supply | Prescription medicines | |
| aripiprazole (ARIPIPRAZOLE GH) 15 mg tablet blister pack | Generic Health Pty Ltd | 176810 | CON-106 | The consent is effective from 8 November 2016 until 31 August 2017. | 8/11/2016 | The requirements of Part 3-1 – Standards of the Therapeutic Goods Act 1989 (Cth). | The products do not comply with the default standard for the products, i.e. the USP 39 monograph for Aripiprazole Tablets. | The products must continue to meet the currently approved finished product specifications at release and expiry. | Import and supply | Prescription medicines | |
| aripiprazole (ARIPIPRAZOLE GH) 10 mg tablet blister pack | Generic Health Pty Ltd | 176808 | CON-106 | The consent is effective from 8 November 2016 until 31 August 2017. | 8/11/2016 | The requirements of Part 3-1 – Standards of the Therapeutic Goods Act 1989 (Cth). | The products do not comply with the default standard for the products, i.e. the USP 39 monograph for Aripiprazole Tablets. | The products must continue to meet the currently approved finished product specifications at release and expiry. | Import and supply | Prescription medicines | |
| aripiprazole (ARIPIPRAZOLE GH) 5 mg tablet blister pack | Generic Health Pty Ltd | 176806 | CON-106 | The consent is effective from 8 November 2016 until 31 August 2017. | 8/11/2016 | The requirements of Part 3-1 – Standards of the Therapeutic Goods Act 1989 (Cth). | The products do not comply with the default standard for the products, i.e. the USP 39 monograph for Aripiprazole Tablets. | The products must continue to meet the currently approved finished product specifications at release and expiry. | Import and supply | Prescription medicines | |
| aripiprazole (ARIPIPRAZOLE GENERICHEALTH 30) 30 mg tablet blister pack | Generic Health Pty Ltd | 176802 | CON-106 | The consent is effective from 8 November 2016 until 31 August 2017. | 8/11/2016 | The requirements of Part 3-1 – Standards of the Therapeutic Goods Act 1989 (Cth). | The products do not comply with the default standard for the products, i.e. the USP 39 monograph for Aripiprazole Tablets. | The products must continue to meet the currently approved finished product specifications at release and expiry. | Import and supply | Prescription medicines | |
| aripiprazole (ARIPIPRAZOLE GENERICHEALTH 20) 20 mg tablet blister pack | Generic Health Pty Ltd | 176800 | CON-106 | The consent is effective from 8 November 2016 until 31 August 2017. | 8/11/2016 | The requirements of Part 3-1 – Standards of the Therapeutic Goods Act 1989 (Cth). | The products do not comply with the default standard for the products, i.e. the USP 39 monograph for Aripiprazole Tablets. | The products must continue to meet the currently approved finished product specifications at release and expiry. | Import and supply | Prescription medicines | |
| aripiprazole (ARIPIPRAZOLE GENERICHEALTH 15) 15 mg tablet blister pack | Generic Health Pty Ltd | 176797 | CON-106 | The consent is effective from 8 November 2016 until 31 August 2017. | 8/11/2016 | The requirements of Part 3-1 – Standards of the Therapeutic Goods Act 1989 (Cth). | The products do not comply with the default standard for the products, i.e. the USP 39 monograph for Aripiprazole Tablets. | The products must continue to meet the currently approved finished product specifications at release and expiry. | Import and supply | Prescription medicines | |
| aripiprazole (ARIPIPRAZOLE GENERICHEALTH 10) 10 mg tablet blister pack | Generic Health Pty Ltd | 176795 | CON-106 | The consent is effective from 8 November 2016 until 31 August 2017. | 8/11/2016 | The requirements of Part 3-1 – Standards of the Therapeutic Goods Act 1989 (Cth). | The products do not comply with the default standard for the products, i.e. the USP 39 monograph for Aripiprazole Tablets.%23160;%23160; | The products must continue to meet the currently approved finished product specifications at release and expiry. | Import and supply | Prescription medicines | |
| aripiprazole (ARIPIPRAZOLE GENERICHEALTH 5) 5 mg tablet blister pack | Generic Health Pty Ltd | 176793 | CON-106 | The consent is effective from 8 November 2016 until 31 August 2017. | 8/11/2016 | The requirements of Part 3-1 – Standards of the Therapeutic Goods Act 1989 (Cth). | The products do not comply with the default standard for the products, i.e. the USP 39 monograph for Aripiprazole Tablets.%23160;%23160; | The products must continue to meet the currently approved finished product specifications at release and expiry. | Import and supply | Prescription medicines | |
| mitoxantrone hydrochloride (MITOZANTRONE EBEWE) 20 mg/10 mL solution for injection vial | Sandoz Pty Ltd | 132327 | CON-109 | The consent is effective for two years from the 11 November 2016. | 11/11/2016 | The requirements of the official standard for the products, namely the current BP monograph for Sterile Mitoxantrone Concentrate. | The products do not conform to the requirements of the current BP monograph for Sterile Mitoxantrone Concentrate. | The products are tested to and must comply with the finished product specifications (at release and expiry) provided in the application. | Import and supply | Prescription medicines | |
| mitoxantrone hydrochloride (MITOZANTRONE EBEWE) 10 mg/5 mL solution for injection vial | Sandoz Pty Ltd | 132319 | CON-109 | The consent is effective for two years from the 11 November 2016. | 11/11/2016 | The requirements of the official standard for the products, namely the current BP monograph for Sterile Mitoxantrone Concentrate. | The products do not conform to the requirements of the current BP monograph for Sterile Mitoxantrone Concentrate. | The products are tested to and must comply with the finished product specifications (at release and expiry) provided in the application. | Import and supply | Prescription medicines | |
| oxycodone hydrochloride (OXYNORM) injection 50 mg in 1 mL ampoule | Mundipharma Pty Ltd | 152411 | CON-111 | The consent is effective from the 14 November 2016 until 28 February 2017. | 14/11/2016 | sub-clause 3(5)(a)(i) of Therapeutic Goods Order No. 69 General requirements for labels for medicines | The ampoule label does not include the approved routes of administration of the product. | A 'Dear Healthcare Professional' letter identical to that provided to the TGA on 14 November 2016 will be supplied with each affected batch providing information on the need to use the New Zealand packaging for the product. It also advisesuser to replace the Datasheet in the pack with the Australian product information. A copy of the Australian product information for Oxynorm solution for infusion must be supplied with the Dear Healthcare Professional letter referred to in 1. above. The labels (carton, blister and ampoule) to which this consent applies are those provided inthe letter of application, ie the New Zealand product labels. Additionally, the carton label of each affected batch for supply in Australia must be labelled on the back panel with an over-sticker identical to that provided in the electronic mail of 14 November 2016. | Import and supply | Prescription medicines | |
| foscarnet sodium (FOSCAVIR) 6g/250 mL injection bottle | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | 37310 | CON-112 | The consent is effective from 15 November 2016 until 31 March 2017. | 15/11/2016 | Subclauses 3(2)(b), 3(2)(j) and 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The carton and bottle labels do not express the name of the active ingredient or storage condition in the required format. The bottle label also does not bear the current sponsor name and address. | The labels (i.e. UK carton and bottle labels) to which this consent applies are those provided with the initial letter of application dated 20 October 2016, where the carton label includes an over-sticker that details the Australian sponsor name and address, and the AUST R number; and A 'Dear Healthcare Professional' letter identical to that provided to the TGA on 11 November 2016 (TGA ref: R16/899526). will be supplied with the affected product, informing that the product is packaged with UK labelling and advising the Healthcare Professional to disregard the UK packaging insert, and refer instead to the Australian Product Information (PI). | Import and supply | Prescription medicines | |
| bisoprolol fumarate (BISOPROLOL SANDOZ) 10 mg film-coated tablet blister pack | Sandoz Pty Ltd | 144888 | CON-113 | The consent is effective from 18 November 2016 until 30 September 2017. | 18/11/2016 | The requirements of section 8 of Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules. | The finished drug product release and expiry specifications of the products do not comply with the individual monograph of the British Pharmacopoeia for Bisoprolol Fumarate Tablets, particularly for the assay and related substance specifications. | The finished product release and expiry specifications for the products to which this consent applies are those provided as 'attachment 1' withthe letter of application, which are the current specifications approved on 17 August 2016 under submission PM-2016-02260-1-3 and; A compliance check forthe products listed above is to be conducted with the aim of investigating compliance with the BP monograph, as stated inthe letter of application. | Import and supply | Prescription medicines | |
| bisoprolol fumarate (BISOPROLOL SANDOZ) 5 mg film-coated tablet blister pack | Sandoz Pty Ltd | 144884 | CON-113 | The consent is effective from 18 November 2016 until 30 September 2017. | 18/11/2016 | The requirements of section 8 of Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules. | The finished drug product release and expiry specifications of the products do not comply with the individual monograph of the British Pharmacopoeia for Bisoprolol Fumarate Tablets, particularly for the assay and related substance specifications. | The finished product release and expiry specifications for the products to which this consent applies are those provided as 'attachment 1' withthe letter of application, which are the current specifications approved on 17 August 2016 under submission PM-2016-02260-1-3 and; A compliance check forthe products listed above is to be conducted with the aim of investigating compliance with the BP monograph, as stated inthe letter of application. | Import and supply | Prescription medicines | |
| bisoprolol fumarate (BISOPROLOL SANDOZ) 2.5 mg film-coated tablet blister pack | Sandoz Pty Ltd | 144867 | CON-113 | The consent is effective from 18 November 2016 until 30 September 2017. | 18/11/2016 | The requirements of section 8 of Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules. | The finished drug product release and expiry specifications of the products do not comply with the individual monograph of the British Pharmacopoeia for Bisoprolol Fumarate Tablets, particularly for the assay and related substance specifications. | The finished product release and expiry specifications for the products to which this consent applies are those provided as 'attachment 1' withthe letter of application, which are the current specifications approved on 17 August 2016 under submission PM-2016-02260-1-3 and; A compliance check forthe products listed above is to be conducted with the aim of investigating compliance with the BP monograph, as stated inthe letter of application. | Import and supply | Prescription medicines | |
| tafluprost (SAFLUTAN) 15 micrograms per/mL single dose eye drop ampoule | Mundipharma Pty Ltd | 168803 | CON-114 | The consent is effective from 23 November 2016 until: 31 July 2017 (AUST R 66103), 30 Sep 2017 (AUST R 55022), 28 Feb 2018 (AUST R 28775), 30 Apr 2017 (AUST R 50304), 31 Jan 2017 (AUST R 50306), 28 Feb 2017 (AUST R 168803). | 23/11/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels bear the former sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former sponsor, Merck Sharp & Dohme Australia Pty Ltd (MSD) and arrangements are in place with the former sponsor MSD that all queries or complaints concerning the products are redirected to the current sponsor, Mundipharma Pty Ltd. | Supply | Prescription medicines | |
| timolol (as maleate) (TIMOPTOL-XE) 5 mg/mL eye drops bottle | Mundipharma Pty Ltd | 50306 | CON-114 | The consent is effective from 23 November 2016 until: 31 July 2017 (AUST R 66103), 30 Sep 2017 (AUST R 55022), 28 Feb 2018 (AUST R 28775), 30 Apr 2017 (AUST R 50304), 31 Jan 2017 (AUST R 50306), 28 Feb 2017 (AUST R 168803). | 23/11/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels bear the former sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former sponsor, Merck Sharp & Dohme Australia Pty Ltd (MSD) and arrangements are in place with the former sponsor MSD that all queries or complaints concerning the products are redirected to the current sponsor, Mundipharma Pty Ltd. | Supply | Prescription medicines | |
| timolol (as maleate) (TIMOPTOL-XE) 2.5 mg/mL eye drops bottle | Mundipharma Pty Ltd | 50304 | CON-114 | The consent is effective from 23 November 2016 until: 31 July 2017 (AUST R 66103), 30 Sep 2017 (AUST R 55022), 28 Feb 2018 (AUST R 28775), 30 Apr 2017 (AUST R 50304), 31 Jan 2017 (AUST R 50306), 28 Feb 2017 (AUST R 168803). | 23/11/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels bear the former sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former sponsor, Merck Sharp & Dohme Australia Pty Ltd (MSD) and arrangements are in place with the former sponsor MSD that all queries or complaints concerning the products are redirected to the current sponsor, Mundipharma Pty Ltd. | Supply | Prescription medicines | |
| timolol maleate (TIMOPTOL) 0.5% eye drops bottle | Mundipharma Pty Ltd | 28775 | CON-114 | The consent is effective from 23 November 2016 until: 31 July 2017 (AUST R 66103), 30 Sep 2017 (AUST R 55022), 28 Feb 2018 (AUST R 28775), 30 Apr 2017 (AUST R 50304), 31 Jan 2017 (AUST R 50306), 28 Feb 2017 (AUST R 168803). | 23/11/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels bear the former sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former sponsor, Merck Sharp & Dohme Australia Pty Ltd (MSD) and arrangements are in place with the former sponsor MSD that all queries or complaints concerning the products are redirected to the current sponsor, Mundipharma Pty Ltd. | Supply | Prescription medicines | |
| dorzolamide (as hydrochloride) (TRUSOPT) 20 mg/mL eye drops bottle | Mundipharma Pty Ltd | 55022 | CON-114 | The consent is effective from 23 November 2016 until: 31 July 2017 (AUST R 66103), 30 Sep 2017 (AUST R 55022), 28 Feb 2018 (AUST R 28775), 30 Apr 2017 (AUST R 50304), 31 Jan 2017 (AUST R 50306), 28 Feb 2017 (AUST R 168803). | 23/11/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels bear the former sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former sponsor, Merck Sharp & Dohme Australia Pty Ltd (MSD) and arrangements are in place with the former sponsor MSD that all queries or complaints concerning the products are redirected to the current sponsor, Mundipharma Pty Ltd. | Supply | Prescription medicines | |
| dorzolamide hydrochloride 20 mg and timolol maleate 5 mg per mL (COSOPT) eye drop bottle | Mundipharma Pty Ltd | 66103 | CON-114 | The consent is effective from 23 November 2016 until: 31 July 2017 (AUST R 66103), 30 Sep 2017 (AUST R 55022), 28 Feb 2018 (AUST R 28775), 30 Apr 2017 (AUST R 50304), 31 Jan 2017 (AUST R 50306), 28 Feb 2017 (AUST R 168803). | 23/11/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels bear the former sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former sponsor, Merck Sharp & Dohme Australia Pty Ltd (MSD) and arrangements are in place with the former sponsor MSD that all queries or complaints concerning the products are redirected to the current sponsor, Mundipharma Pty Ltd. | Supply | Prescription medicines | |
| busulfan (BUSULFEX) 60 mg/10 mL injection vial | Otsuka Australia Pharmaceutical Pty Ltd | 150612 | CON-115 | The consent is effective from 25 November until 31 July 2018. | 25/11/2016 | Subclauses 3(2)(a), 3(2)(c), 3(5)(b)(i) and 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The proposed vial label to be used does not have the Australian-registered product name, the correct expression of the quantity of the active in the good and name or trade mark of the current sponsor (or supplier) and the single vial and 8 vial carton labels to be used do not have the Australian-registered product name on all panels, the correct expression of the quantity of the active in the good on all panels, the quantity of excipients in the good and the correct name and address of the current sponsor (or supplier) of the product on one side panel. | The US vial label provided with the letter of 16 September 2016 is to be used. The US single vial carton label and US 8 vials carton label provided with the letter of 16 September 2016 are to be used but over-stickered on the main label with the information provided in the same letter of 16 September 2016. This over-sticker includes the Australia registered product name, the ARTG number and the contact details of the previous sponsor, Orphan Australia Pty Ltd The US Product Information (PI) will be removed from the cartons containing the single vial and the Australian approved PI will be included inside the outer carton containing the 8 single vial cartons Arrangements are in place with the former sponsor, Orphan Australia Pty Ltd, for the prompt referral of any queries or complaints concerning the products to Otsuka Australia Pharmaceutical Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| travoprost 0.004% (TRAVATAN) 40 microgram/mL eye drop solution bottle | Alcon Laboratories Australia Pty Ltd | 173354 | CON-116 | The consent is effective from 28 November 2016. | 28/11/2016 | The official standard, the USP monograph for Travoprost Ophthalmic Solution. | The drug product expiry pH limit is 6.4-7.0 rather than 5.5-6.4 as required by the official standard. | The drug product expiry specifications to which this consent applies are those currently approved for TRAVATAN (AUST R 173354). | Import and supply | Prescription medicines | |
| amifostine (ETHYOL) powder for injection 500 mg vial | Link Medical Products Pty Ltd | 63789 | HB2173 | CON-117 | The consent is effective from the 29 November 2016 until 31 August 2018. | 29/11/2016 | Sub-clause 3(1)(a) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The product does not comply with the requirements in that the information on the carton and vial labels are not in the English language. | The 'Dear Healthcare Professional' letter identical to that provided to the TGA inthe application must be supplied with each dispensed unit of batch HB 2173 of the product. The carton and vial labels for batch HB2173 are identical to the representative French product labels (with the Clinigen company details) provided inthe application. The main panel of the carton label must be over-stickered with the over-label provided inthe email of 28 November 2016. The French package insert must be replaced with the Australian package insert in each dispensed unit of batch HB2173 of the product. | Import and supply | Prescription medicines |
| desmopressin (as acetate) (NOCDURNA) 50 micrograms sublingual wafers blister pack | Ferring Pharmaceuticals Pty Ltd | 264292 | CON-121 | The consent is effective from 30 November 2016 until 30 November 2017. | 30/11/2016 | Section 11(b) of Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules. | with regard to the lower assay expiry limit. | Assay limits of 90.0-110.0% at expiry are approved for the products and; This exemption applies for one year from the date of approval of the products. | Supply | Prescription medicines | |
| desmopressin (as acetate) (NOCDURNA) 25 micrograms sublingual wafers blister pack | Ferring Pharmaceuticals Pty Ltd | 263596 | CON-121 | The consent is effective from 30 November 2016 until 30 November 2017. | 30/11/2016 | Section 11(b) of Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules. | with regard to the lower assay expiry limit. | Assay limits of 90.0-110.0% at expiry are approved for the products and; This exemption applies for one year from the date of approval of the products. | Supply | Prescription medicines | |
| QUADRACEL 0.5 mL injection vial | Sanofi Aventis Australia Pty Ltd | 91355 | C5146BD | CON-118 | The consent is effective from the 30 November 2016 until the expiry date of the batch, on 31 August 2018. | 30/11/2016 | Does not conform with the requirements of the European Pharmacopoeia. | It is tested to the United States, rather than Australian specifications, as detailed in the application letter. | This consent applies only to 24725 doses from Quadracel batch C5146BD; Non”compliance with the European Pharmacopoeia (Ph. Eur.) requirements is limited to the tests detailed in the application; The doses will be labelled in the Australian approved labels (carton, vial and package insert); The company will provide TGA with a copy of the Release Certificate of the above batch from US CBER; Normal TGA batch release processes will apply to this batch. | Import and supply | Prescription medicines |
| ropivacaine hydrochloride 2 mg/mL and fentanyl 4 microgram/mL (as citrate) (NAROPIN 0.2% WITH FENTANYL 400 microgram/100 mL) 100 mL injection bag | Aspen Pharmacare Australia Pty Ltd | 72876 | CON-127 | 1 December 2016 to 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| ropivacaine hydrochloride 2 mg/mL and fentanyl 4 microgram/mL (as citrate) (NAROPIN 0.2% WITH FENTANYL 800 microgram/200 mL) 200 mL injection bag | Aspen Pharmacare Australia Pty Ltd | 72875 | CON-127 | 1 December 2016 to 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| ropivacaine hydrochloride 2 mg/mL and fentanyl 2 microgram/mL (as citrate) (NAROPIN 0.2% WITH FENTANYL 200 microgram/100 mL) 100 mL injection bag | Aspen Pharmacare Australia Pty Ltd | 72874 | CON-127 | 1 December 2016 to 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| ropivacaine hydrochloride 2 mg/mL and fentanyl 2 microgram/mL (as citrate) (NAROPIN 0.2% WITH FENTANYL 400 microgram/200 mL) 200 mL injection bag | Aspen Pharmacare Australia Pty Ltd | 72873 | CON-127 | 1 December 2016 to 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| ropivacaine hydrochloride (NAROPIN 0.2%) 20 mg/10 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 52406 | CON-127 | 1 December 2016 to 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| ropivacaine hydrochloride (NAROPIN 0.2%) 40 mg/20 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 52405 | CON-127 | 1 December 2016 to 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| ropivacaine hydrochloride (NAROPIN 0.5%) 50 mg/10 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 52402 | CON-127 | 1 December 2016 to 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| ropivacaine hydrochloride (NAROPIN 0.5%) 100 mg/20 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 52401 | CON-127 | 1 December 2016 to 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| ropivacaine hydrochloride (NAROPIN 0.75%) 75 mg/10 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 52400 | CON-127 | 1 December 2016 to 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| ropivacaine hydrochloride (NAROPIN 0.75%) 150 mg/20 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 52399 | CON-127 | 1 December 2016 to 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| ropivacaine hydrochloride (NAROPIN 1%) 100 mg/10 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 52398 | CON-127 | 1 December 2016 to 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| ropivacaine hydrochloride (NAROPIN 1%) 200 mg/20 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 52397 | CON-127 | 1 December 2016 to 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| ropivacaine hydrochloride (NAROPIN 0.2%) 200 mg/100 mL injection bag | Aspen Pharmacare Australia Pty Ltd | 52396 | CON-127 | 1 December 2016 to 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| ropivacaine hydrochloride (NAROPIN 0.2%) 400 mg/200 mL injection bag | Aspen Pharmacare Australia Pty Ltd | 52395 | CON-127 | 1 December 2016 to 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| propofol (DIPRIVAN) 200 mg/20 mL injection vial | Aspen Pharmacare Australia Pty Ltd | 77251 | CON-120 | The consent is effective from 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO No. 69). | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor, AstraZeneca Pty Ltd and arrangements are in place with the former sponsor, for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| propofol (DIPRIVAN) 500 mg/50 mL injection vial | Aspen Pharmacare Australia Pty Ltd | 75565 | CON-120 | The consent is effective from 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO No. 69). | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor, AstraZeneca Pty Ltd and arrangements are in place with the former sponsor, for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| propofol (DIPRIVAN) 1 g/100 mL injection vial | Aspen Pharmacare Australia Pty Ltd | 75564 | CON-120 | The consent is effective from 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO No. 69). | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor, AstraZeneca Pty Ltd and arrangements are in place with the former sponsor, for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| propofol (DIPRIVAN) 500 mg/50 mL injection syringe | Aspen Pharmacare Australia Pty Ltd | 75562 | CON-120 | The consent is effective from 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO No. 69). | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor, AstraZeneca Pty Ltd and arrangements are in place with the former sponsor, for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| prilocaine hydrochloride (CITANEST 2% POLYAMP DUOFIT) 100 mg/5 mL injection BP ampoule | Aspen Pharmacare Australia Pty Ltd | 53722 | CON-120 | The consent is effective from 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO No. 69). | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor, AstraZeneca Pty Ltd and arrangements are in place with the former sponsor, for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| prilocaine hydrochloride (CITANEST 1% POLYAMP DUOFIT) 50 mg/5 mL injection BP ampoule | Aspen Pharmacare Australia Pty Ltd | 53721 | CON-120 | The consent is effective from 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO No. 69). | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor, AstraZeneca Pty Ltd and arrangements are in place with the former sponsor, for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| prilocaine hydrochloride (CITANEST 0.5%) 250 mg/50 mL injection vial | Aspen Pharmacare Australia Pty Ltd | 12079 | CON-120 | The consent is effective from 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO No. 69). | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor, AstraZeneca Pty Ltd and arrangements are in place with the former sponsor, for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| lidocaine (lignocaine) hydrochloride (XYLOCARD 500) 500 mg/5 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 12036 | CON-120 | The consent is effective from 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO No. 69). | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor, AstraZeneca Pty Ltd and arrangements are in place with the former sponsor, for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| lidocaine (lignocaine) hydrochloride (XYLOCARD 1000) 1 g/10 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 12035 | CON-120 | The consent is effective from 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO No. 69). | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor, AstraZeneca Pty Ltd and arrangements are in place with the former sponsor, for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| lidocaine (lignocaine) hydrochloride (XYLOCARD 100) 100 mg/5 mL injection ampoule kit | Aspen Pharmacare Australia Pty Ltd | 12032 | CON-120 | The consent is effective from 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO No. 69). | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor, AstraZeneca Pty Ltd and arrangements are in place with the former sponsor, for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| bupivacaine hydrochloride monohydrate 1.25 mg/mL and fentanyl 5 microgram/mL (as citrate) (MARCAIN 0.125% WITH FENTANYL) 1000 microgram/200 mL) 200 mL injection bag | Aspen Pharmacare Australia Pty Ltd | 72870 | CON-119 | The consent is effective from the 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of The Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca PtyLtd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| bupivacaine hydrochloride (as monohydrate) (MARCAIN 0.375%) 75 mg/20 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 52691 | CON-119 | The consent is effective from the 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of The Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca PtyLtd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| bupivacaine hydrochloride (as monohydrate) (MARCAIN 0.25%) 50 mg/20 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 48380 | CON-119 | The consent is effective from the 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of The Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca PtyLtd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| bupivacaine hydrochloride (as monohydrate) (MARCAIN 0.125% EPIDURAL INFUSION) 250 mg/200 mL injection bag | Aspen Pharmacare Australia Pty Ltd | 48374 | CON-119 | The consent is effective from the 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of The Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca PtyLtd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| bupivacaine hydrochloride (as monohydrate) 1.25 mg/mL and fentanyl 5 microgram/mL (as citrate) (MARCAIN 0.125% WITH FENTANYL 100 microgram/20 mL) 20 mL injection vial | Aspen Pharmacare Australia Pty Ltd | 48341 | CON-119 | The consent is effective from the 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of The Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca PtyLtd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| MARCAIN 0.5% WITH ADRENALINE 1:200,000 20 mL injection viaL | Aspen Pharmacare Australia Pty Ltd | 48329 | CON-119 | The consent is effective from the 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of The Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca PtyLtd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| bupivacaine hydrochloride (as monohydrate) (MARCAIN 0.5% w/v) 100 mg/20 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 48328 | CON-119 | The consent is effective from the 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of The Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca PtyLtd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| bupivacaine hydrochloride anhydrous (MARCAIN SPINAL 0.5%) 20 mg/4 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 21016 | CON-119 | The consent is effective from the 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of The Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca PtyLtd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| MARCAIN 0.25% WITH ADRENALINE 1:400,000 20 mL injection vial | Aspen Pharmacare Australia Pty Ltd | 125878 | CON-119 | The consent is effective from the 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of The Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca PtyLtd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| bupivacaine hydrochloride (as monohydrate) (MARCAIN 0.125% EPIDURAL INFUSION) 125 mg/100 mL injection bag | Aspen Pharmacare Australia Pty Ltd | 12424 | CON-119 | The consent is effective from the 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of The Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca PtyLtd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| bupivacaine hydrochloride (as monohydrate) 1.25mg/mL and fentanyl 5 microgram/mL (as citrate) (MARCAIN 0.125% WITH FENTANYL 100 microgram/20mL) 20 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 123384 | CON-119 | The consent is effective from the 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of The Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca PtyLtd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| bupivacaine hydrochloride (as monohydrate) (MARCAIN 0.25% EPIDURAL INFUSION) 250 mg/100 mL injection bag | Aspen Pharmacare Australia Pty Ltd | 11953 | CON-119 | The consent is effective from the 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of The Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca PtyLtd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| bupivacaine hydrochloride anhydrous (MARCAIN SPINAL 0.5% HEAVY) 20 mg/4 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 11941 | CON-119 | The consent is effective from the 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of The Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca PtyLtd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| bupivacaine hydrochloride monohydrate (MARCAIN 0.5%) 50 mg/10 mL injection vial | Aspen Pharmacare Australia Pty Ltd | 11940 | CON-119 | The consent is effective from the 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of The Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca PtyLtd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| MARCAIN 0.5% WITH ADRENALINE 1:200,000 10 mL injection vial | Aspen Pharmacare Australia Pty Ltd | 11939 | CON-119 | The consent is effective from the 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of The Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca PtyLtd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| bupivacaine hydrochloride monohydrate (MARCAIN 0.5%) 50 mg/10 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 11937 | CON-119 | The consent is effective from the 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of The Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca PtyLtd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| MARCAIN 0.25% WITH ADRENALINE 1:400,000 10 mL injection vial | Aspen Pharmacare Australia Pty Ltd | 11935 | CON-119 | The consent is effective from the 1 December 2016 until 30 November 2018. | 1/12/2016 | Sub-clause 3(2)((l) of The Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca PtyLtd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| XYLOCAINE 2% WITH ADRENALINE 1:200,000 20 mL injection vial | Aspen Pharmacare Australia Pty Ltd | 12021 | CON-128 | 5 December 2016 to 30 November 2018. | 5/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| XYLOCAINE 2% WITH ADRENALINE 1:80,000 5 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 54520 | CON-128 | 5 December 2016 to 30 November 2018. | 5/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| lidocaine (lignocaine) hydrochloride (XYLOCAINE 2%) 400 mg/20 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 48364 | CON-128 | 5 December 2016 to 30 November 2018. | 5/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| lidocaine (lignocaine) hydrochloride (XYLOCAINE 2%) 100 mg/5 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 48362 | CON-128 | 5 December 2016 to 30 November 2018. | 5/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| lidocaine (lignocaine) hydrochloride (XYLOCAINE 1%) 200 mg/20 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 48361 | CON-128 | 5 December 2016 to 30 November 2018. | 5/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| lidocaine (lignocaine) hydrochloride (XYLOCAINE 1%)50 mg/5 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 48357 | CON-128 | 5 December 2016 to 30 November 2018. | 5/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| lidocaine (lignocaine) hydrochloride (XYLOCAINE 2%)40 mg/2 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 12020 | CON-128 | 5 December 2016 to 30 November 2018. | 5/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| XYLOCAINE 1% WITH ADRENALINE 1:100,000 5 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 12017 | CON-128 | 5 December 2016 to 30 November 2018. | 5/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| XYLOCAINE 1% WITH ADRENALINE 1:200,000 20 mL injection vial | Aspen Pharmacare Australia Pty Ltd | 12015 | CON-128 | 5 December 2016 to 30 November 2018. | 5/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| lidocaine (lignocaine) hydrochloride (XYLOCAINE 1%) 20 mg/2 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 12013 | CON-128 | 5 December 2016 to 30 November 2018. | 5/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| XYLOCAINE 1.5% WITH ADRENALINE 1:200,000 20 mL injection vial | Aspen Pharmacare Australia Pty Ltd | 12011 | CON-128 | 5 December 2016 to 30 November 2018. | 5/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| lidocaine (lignocaine) hydrochloride (XYLOCAINE 0.5%) 25 mg/5 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 12009 | CON-128 | 5 December 2016 to 30 November 2018. | 5/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| XYLOCAINE 0.5% WITH ADRENALINE 1:200,000 20 mL injection vial | Aspen Pharmacare Australia Pty Ltd | 12008 | CON-128 | 5 December 2016 to 30 November 2018. | 5/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| nicotine (NICABATE GUM EXTRA FRESH MINT) 4 mg coated chewing gum blister pack | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 258233 | F001070AU, G001070AU, G001070AU2, G001076AU, F001079AU, G001077AU, G001077AU2, G001079AU, G001096AU, G001096AU2, G001101AU, G001104AU | CON-122 | The consent is effective from 8 December 2016 until 1 December 2017. | 8/12/2016 | Subclause 3(3) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The main labels do not include the name of the active ingredient nicotine. | Import and supply | Over-the-counter medicines | |
| nicotine (NICABATE GUM EXTRA FRESH MINT) 2 mg coated chewing gum blister pack | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 258232 | F001069AU, G001069AU, F001069AU2, G001069AU2, F001078AU, G001078AU, G001095AU | CON-122 | The consent is effective from 8 December 2016 until 1 December 2017. | 8/12/2016 | Subclause 3(3) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The main labels do not include the name of the active ingredient nicotine. | Import and supply | Over-the-counter medicines | |
| oxycodone hydrochloride (OXYCONTIN) 10 mg modified release tablet bottle | Mundipharma Pty Ltd | 200037 | CON-124 | The consent is effective from 9 December 2016 until 9 December 2018. | 9/12/2016 | British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets. | The products do not comply with the current British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets in regard to the test limits for assay and related substances. | The products comply with the requirements of the current British Pharmacopoeia (BP) monograph for Prolonged-release Oxycodone Tablets except for the tests and limits for assay and related substances. The products must comply with the currently approved finished expiry specifications throughout their shelf life, including use of the in-house test methods. The on-going stability testing of the 10 mg (batches 185644 and 192704) and 15 mg (batch 192705) tablets should continue to at least 36 months when store at 25°C/60%RH in order to obtain more data to verify/confirm any trend in assay and formation of the N-oxide impurity. | Import and supply | Prescription medicines | |
| oxycodone hydrochloride (OXYCONTIN) 40 mg modified release tablet bottle | Mundipharma Pty Ltd | 200036 | CON-124 | The consent is effective from 9 December 2016 until 9 December 2018. | 9/12/2016 | British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets. | The products do not comply with the current British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets in regard to the test limits for assay and related substances. | The products comply with the requirements of the current British Pharmacopoeia (BP) monograph for Prolonged-release Oxycodone Tablets except for the tests and limits for assay and related substances. The products must comply with the currently approved finished expiry specifications throughout their shelf life, including use of the in-house test methods. The on-going stability testing of the 10 mg (batches 185644 and 192704) and 15 mg (batch 192705) tablets should continue to at least 36 months when store at 25°C/60%RH in order to obtain more data to verify/confirm any trend in assay and formation of the N-oxide impurity. | Import and supply | Prescription medicines | |
| oxycodone hydrochloride (OXYCONTIN) 20 mg modified release tablet bottle | Mundipharma Pty Ltd | 200035 | CON-124 | The consent is effective from 9 December 2016 until 9 December 2018. | 9/12/2016 | British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets. | The products do not comply with the current British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets in regard to the test limits for assay and related substances. | The products comply with the requirements of the current British Pharmacopoeia (BP) monograph for Prolonged-release Oxycodone Tablets except for the tests and limits for assay and related substances. The products must comply with the currently approved finished expiry specifications throughout their shelf life, including use of the in-house test methods. The on-going stability testing of the 10 mg (batches 185644 and 192704) and 15 mg (batch 192705) tablets should continue to at least 36 months when store at 25°C/60%RH in order to obtain more data to verify/confirm any trend in assay and formation of the N-oxide impurity. | Import and supply | Prescription medicines | |
| oxycodone hydrochloride (OXYCONTIN) 80 mg modified release tablet bottle | Mundipharma Pty Ltd | 200034 | CON-124 | The consent is effective from 9 December 2016 until 9 December 2018. | 9/12/2016 | British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets. | The products do not comply with the current British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets in regard to the test limits for assay and related substances. | The products comply with the requirements of the current British Pharmacopoeia (BP) monograph for Prolonged-release Oxycodone Tablets except for the tests and limits for assay and related substances. The products must comply with the currently approved finished expiry specifications throughout their shelf life, including use of the in-house test methods. The on-going stability testing of the 10 mg (batches 185644 and 192704) and 15 mg (batch 192705) tablets should continue to at least 36 months when store at 25°C/60%RH in order to obtain more data to verify/confirm any trend in assay and formation of the N-oxide impurity. | Import and supply | Prescription medicines | |
| oxycodone hydrochloride (OXYCONTIN) 20 mg modified release tablet blister pack | Mundipharma Pty Ltd | 200033 | CON-124 | The consent is effective from 9 December 2016 until 9 December 2018. | 9/12/2016 | British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets. | The products do not comply with the current British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets in regard to the test limits for assay and related substances. | The products comply with the requirements of the current British Pharmacopoeia (BP) monograph for Prolonged-release Oxycodone Tablets except for the tests and limits for assay and related substances. The products must comply with the currently approved finished expiry specifications throughout their shelf life, including use of the in-house test methods. The on-going stability testing of the 10 mg (batches 185644 and 192704) and 15 mg (batch 192705) tablets should continue to at least 36 months when store at 25°C/60%RH in order to obtain more data to verify/confirm any trend in assay and formation of the N-oxide impurity. | Import and supply | Prescription medicines | |
| oxycodone hydrochloride (OXYCONTIN) 60 mg modified release tablet blister pack | Mundipharma Pty Ltd | 200032 | CON-124 | The consent is effective from 9 December 2016 until 9 December 2018. | 9/12/2016 | British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets. | The products do not comply with the current British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets in regard to the test limits for assay and related substances. | The products comply with the requirements of the current British Pharmacopoeia (BP) monograph for Prolonged-release Oxycodone Tablets except for the tests and limits for assay and related substances. The products must comply with the currently approved finished expiry specifications throughout their shelf life, including use of the in-house test methods. The on-going stability testing of the 10 mg (batches 185644 and 192704) and 15 mg (batch 192705) tablets should continue to at least 36 months when store at 25°C/60%RH in order to obtain more data to verify/confirm any trend in assay and formation of the N-oxide impurity. | Import and supply | Prescription medicines | |
| oxycodone hydrochloride OXYCONTIN 10 mg modified release tablet blister pack | Mundipharma Pty Ltd | 200031 | CON-124 | The consent is effective from 9 December 2016 until 9 December 2018. | 9/12/2016 | British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets. | The products do not comply with the current British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets in regard to the test limits for assay and related substances. | The products comply with the requirements of the current British Pharmacopoeia (BP) monograph for Prolonged-release Oxycodone Tablets except for the tests and limits for assay and related substances. The products must comply with the currently approved finished expiry specifications throughout their shelf life, including use of the in-house test methods. The on-going stability testing of the 10 mg (batches 185644 and 192704) and 15 mg (batch 192705) tablets should continue to at least 36 months when store at 25°C/60%RH in order to obtain more data to verify/confirm any trend in assay and formation of the N-oxide impurity. | Import and supply | Prescription medicines | |
| oxycodone hydrochloride (OXYCONTIN) 80 mg modified release tablet blister pack | Mundipharma Pty Ltd | 200030 | CON-124 | The consent is effective from 9 December 2016 until 9 December 2018. | 9/12/2016 | British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets. | The products do not comply with the current British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets in regard to the test limits for assay and related substances. | The products comply with the requirements of the current British Pharmacopoeia (BP) monograph for Prolonged-release Oxycodone Tablets except for the tests and limits for assay and related substances. The products must comply with the currently approved finished expiry specifications throughout their shelf life, including use of the in-house test methods. The on-going stability testing of the 10 mg (batches 185644 and 192704) and 15 mg (batch 192705) tablets should continue to at least 36 months when store at 25°C/60%RH in order to obtain more data to verify/confirm any trend in assay and formation of the N-oxide impurity. | Import and supply | Prescription medicines | |
| oxycodone hydrochloride (OXYCONTIN) 60 mg modified release tablet bottle | Mundipharma Pty Ltd | 200029 | CON-124 | The consent is effective from 9 December 2016 until 9 December 2018. | 9/12/2016 | British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets. | The products do not comply with the current British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets in regard to the test limits for assay and related substances. | The products comply with the requirements of the current British Pharmacopoeia (BP) monograph for Prolonged-release Oxycodone Tablets except for the tests and limits for assay and related substances. The products must comply with the currently approved finished expiry specifications throughout their shelf life, including use of the in-house test methods. The on-going stability testing of the 10 mg (batches 185644 and 192704) and 15 mg (batch 192705) tablets should continue to at least 36 months when store at 25°C/60%RH in order to obtain more data to verify/confirm any trend in assay and formation of the N-oxide impurity. | Import and supply | Prescription medicines | |
| oxycodone hydrochloride (OXYCONTIN) 30 mg modified release tablet bottle | Mundipharma Pty Ltd | 200028 | CON-124 | The consent is effective from 9 December 2016 until 9 December 2018. | 9/12/2016 | British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets. | The products do not comply with the current British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets in regard to the test limits for assay and related substances. | The products comply with the requirements of the current British Pharmacopoeia (BP) monograph for Prolonged-release Oxycodone Tablets except for the tests and limits for assay and related substances. The products must comply with the currently approved finished expiry specifications throughout their shelf life, including use of the in-house test methods. The on-going stability testing of the 10 mg (batches 185644 and 192704) and 15 mg (batch 192705) tablets should continue to at least 36 months when store at 25°C/60%RH in order to obtain more data to verify/confirm any trend in assay and formation of the N-oxide impurity. | Import and supply | Prescription medicines | |
| oxycodone hydrochloride (OXYCONTIN) 15 mg modified release tablet bottle | Mundipharma Pty Ltd | 200027 | CON-124 | The consent is effective from 9 December 2016 until 9 December 2018. | 9/12/2016 | British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets. | The products do not comply with the current British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets in regard to the test limits for assay and related substances. | The products comply with the requirements of the current British Pharmacopoeia (BP) monograph for Prolonged-release Oxycodone Tablets except for the tests and limits for assay and related substances. The products must comply with the currently approved finished expiry specifications throughout their shelf life, including use of the in-house test methods. The on-going stability testing of the 10 mg (batches 185644 and 192704) and 15 mg (batch 192705) tablets should continue to at least 36 months when store at 25°C/60%RH in order to obtain more data to verify/confirm any trend in assay and formation of the N-oxide impurity. | Import and supply | Prescription medicines | |
| oxycodone hydrochloride (OXYCONTIN) 15 mg modified release tablet blister pack | Mundipharma Pty Ltd | 200026 | CON-124 | The consent is effective from 9 December 2016 until 9 December 2018. | 9/12/2016 | British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets. | The products do not comply with the current British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets in regard to the test limits for assay and related substances. | The products comply with the requirements of the current British Pharmacopoeia (BP) monograph for Prolonged-release Oxycodone Tablets except for the tests and limits for assay and related substances. The products must comply with the currently approved finished expiry specifications throughout their shelf life, including use of the in-house test methods. The on-going stability testing of the 10 mg (batches 185644 and 192704) and 15 mg (batch 192705) tablets should continue to at least 36 months when store at 25°C/60%RH in order to obtain more data to verify/confirm any trend in assay and formation of the N-oxide impurity. | Import and supply | Prescription medicines | |
| oxycodone hydrochloride (OXYCONTIN) 30 mg modified release tablet blister pack | Mundipharma Pty Ltd | 200025 | CON-124 | The consent is effective from 9 December 2016 until 9 December 2018. | 9/12/2016 | British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets. | The products do not comply with the current British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets in regard to the test limits for assay and related substances. | The products comply with the requirements of the current British Pharmacopoeia (BP) monograph for Prolonged-release Oxycodone Tablets except for the tests and limits for assay and related substances. The products must comply with the currently approved finished expiry specifications throughout their shelf life, including use of the in-house test methods. The on-going stability testing of the 10 mg (batches 185644 and 192704) and 15 mg (batch 192705) tablets should continue to at least 36 months when store at 25°C/60%RH in order to obtain more data to verify/confirm any trend in assay and formation of the N-oxide impurity. | Import and supply | Prescription medicines | |
| oxycodone hydrochloride (OXYCONTIN) 40 mg modified release tablet blister pack | Mundipharma Pty Ltd | 200024 | CON-124 | The consent is effective from 9 December 2016 until 9 December 2018. | 9/12/2016 | British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets. | The products do not comply with the current British Pharmacopoeia (BP) monograph 2016 for Prolonged-release Oxycodone Tablets in regard to the test limits for assay and related substances. | The products comply with the requirements of the current British Pharmacopoeia (BP) monograph for Prolonged-release Oxycodone Tablets except for the tests and limits for assay and related substances. The products must comply with the currently approved finished expiry specifications throughout their shelf life, including use of the in-house test methods. The on-going stability testing of the 10 mg (batches 185644 and 192704) and 15 mg (batch 192705) tablets should continue to at least 36 months when store at 25°C/60%RH in order to obtain more data to verify/confirm any trend in assay and formation of the N-oxide impurity. | Import and supply | Prescription medicines | |
| ivacaftor (KALYDECO) 75 mg granules sachet | Vertex Pharmaceuticals Australia Pty Ltd | 269661 | CON-123 | The consent is effective from 9 December 2016 until 31 May 2017. | 9/12/2016 | Subclause 3(12)(b) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product wallet and sachet labels do not bear the name or registered trademark of the Australian sponsor or supplier of the goods. | The labels (UK carton, wallet and sachet labels) to which this applies are those provided with the TudorRose Consulting's letter of application and the UK carton labels will be over-stickered with the information in relation to the name and address of sponsor, ARTG number and statements 'Prescription Only Medicine' and 'Keep out of reach of children'. | Import and supply | Prescription medicines | |
| ivacaftor (KALYDECO) 50 mg granules sachet | Vertex Pharmaceuticals Australia Pty Ltd | 267390 | CON-123 | The consent is effective from 9 December 2016 until 31 May 2017. | 9/12/2016 | Subclause 3(12)(b) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product wallet and sachet labels do not bear the name or registered trademark of the Australian sponsor or supplier of the goods. | The labels (UK carton, wallet and sachet labels) to which this applies are those provided with the TudorRose Consulting's letter of application and the UK carton labels will be over-stickered with the information in relation to the name and address of sponsor, ARTG number and statements 'Prescription Only Medicine' and 'Keep out of reach of children'. | Import and supply | Prescription medicines | |
| ethosuximide (ZARONTIN) 250 mg capsule bottle | Clinect Pty Ltd | 94175 | CON-126 | 12 December 2016 to 31 December 2017. | 12/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | the labels do not include the current sponsor's name and address. | The labels to which this consent applies are those previously approved for the former sponsor, Pfizer Australia Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Clinect Pty Ltd [the current sponsor]. | Supply | Prescription medicines | |
| ethosuximide (ZARONTIN SYRUP) 250 mg/5 mL oral liquid bottle | Clinect Pty Ltd | 79031 | CON-126 | 12 December 2016 to 31 December 2017. | 12/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | the labels do not include the current sponsor's name and address. | The labels to which this consent applies are those previously approved for the former sponsor, Pfizer Australia Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Clinect Pty Ltd [the current sponsor]. | Supply | Prescription medicines | |
| netupitant/palonosetron (as hydrochloride) (AKYNZEO) 300 mg/500 mcg capsule blister pack | Mundipharma Pty Ltd | 222237 | 36000629 and 36001742 | CON-125 | 12 December 2016 to 1 December 2017. | 12/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor, Specialized Therapeutics Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Mundipharma Pty Ltd [the current sponsor]. The exemption applies to batches 36001740 and 36001741 (Aloxi) and batches 36000629 and 36001742 (Akynzeo). | Supply | Prescription medicines |
| palonosetron (as hydrochloride) (ALOXI) 250 microgram/5 mL solution for injection vial | Mundipharma Pty Ltd | 114185 | 36001740 and 36001741 | CON-125 | 12 December 2016 to 1 December 2017. | 12/12/2016 | Sub-clause 3(2)((l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | the labels include the name and address of the previous sponsor of the products. | The labels to which this consent applies are those previously approved for the former sponsor, Specialized Therapeutics Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Mundipharma Pty Ltd [the current sponsor]. The exemption applies to batches 36001740 and 36001741 (Aloxi) and batches 36000629 and 36001742 (Akynzeo). | Supply | Prescription medicines |
| flumazenil (ANEXATE) 0.5 mg/5 mL injection ampoule | Pharmaco Australia Ltd | 13706 | CON-130 | The consent is effective from 15 December 2016 until 15 June 2018. | 15/12/2016 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | the product carton and ampoule labels do not bear the current sponsor's name and address. | The labels to which this consent applies are those currently approved for the former sponsor Roche Products Pty Ltd and arrangements are in place with the former sponsor Roche Products Pty Ltd that any customer enquiries and reports concerning the products will be forwarded to Pharmaco Australia Ltd (current sponsor). | Supply | Prescription medicines | |
| VANCOMYCIN ALPHAPHARM (as hydrochloride) 500 mg powder for injection vial | Alphapharm Pty Ltd | 153438 | CON-132 | The consent is effective from the 19 December 2016 until 18 December 2017. | 19/12/2016 | Subclauses 3(2)(a), 3(2)(e), 3(5)(b)(ii) and 3(11) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | the product is packaged with New Zealand labels, where the carton label does not bear the Australian registered product name; it does not express the dosage form as per Australian requirements; and the statement 'Contains no antimicrobial preservative' or words to that effect is in not included. The vial label does not bear the name or registered trade mark of the sponsor or supplier or the proprietary name (i.e. Australian registered product name), and does not express the dosage form as per Australian requirements. | The labels to which this consent applies are the New Zealand carton and vial labels provided with the application dated 16 December 2016 and the carton label will be over-stickered with the name and address of the Australian sponsor, and the AUST R number; and A 'Dear Healthcare Provider' letter identical to that provided to the TGA with the application (TGA reference: R16/996709) will be supplied with the product advising users of the situation concerning the product, including advising the healthcare professional to refer to the Australian PI when using the New Zealand labelled stock. | Import and supply | Prescription medicines | |
| carfilzomib (KYPROLIS) 60 mg powder for injection vial | Amgen Australia Pty Ltd | 283228 | CON-133 | The consent is effective from 22 December 2016 until 22 June 2017. | 22/12/2016 | Clauses 3(2)(e), 3(2)(l), 3(2)(n), 3(5)(b)(i) and (ii) of the Therapeutic Goods Order No. 69 — General requirements for labels for medicines. | The labels do not include all required text in the required form. | All dispensing sites will be advised of the supply of the US commercial presentation via the letter supplied to the TGA on 16 December 2016; The product is supplied with a copy of the approved Australian Product Information; The product is supplied with a copy of the Consumer Medicine Information, which includes the AUST R number of the product. | Import and supply | Prescription medicines | |
| lidocaine (lignocaine) hydrochloride (XYLOCAINE VISCOUS)21.4 mg/mL oral liquid (reformulation) | Aspen Pharmacare Australasia Pty Ltd | 213200 | CON-134 | 13 January 2017 until 30 June 2018. | 13/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels of medicines. | The products display the name and address of the old sponsor AstraZeneca Pty Ltd. | Import and supply | Over-the-counter medicines | ||
| lidocaine (lignocaine) hydrochloride (XYLOCAINE VISCOUS) 21.3 mg/mL oral liquid bottle | Aspen Pharmacare Australasia Pty Ltd | 12007 | CON-134 | 13 January 2017 until 30 June 2018. | 13/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels of medicines. | The products display the name and address of the old sponsor AstraZeneca Pty Ltd. | Import and supply | Over-the-counter medicines | ||
| lidocaine (lignocaine) (XYLOCAINE SPECIAL ADHESIVE) 100 mg/g ointment tube | Aspen Pharmacare Australasia Pty Ltd | 12006 | CON-134 | 13 January 2017 until 30 June 2018. | 13/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels of medicines. | The products display the name and address of the old sponsor AstraZeneca Pty Ltd. | Import and supply | Over-the-counter medicines | ||
| lidocaine (lignocaine) (XYLOCAINE 5% OINTMENT) 50 mg/g tube (refomulation) | Aspen Pharmacare Australasia Pty Ltd | 215796 | CON-134 | 13 January 2017 until 30 June 2018. | 13/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels of medicines. | The products display the name and address of the old sponsor AstraZeneca Pty Ltd. | Import and supply | Over-the-counter medicines | ||
| lidocaine (lignocaine) (XYLOCAINE 5% OINTMENT) 50 mg/g tube | Aspen Pharmacare Australasia Pty Ltd | 12005 | CON-134 | 13 January 2017 until 30 June 2018. | 13/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels of medicines. | The products display the name and address of the old sponsor AstraZeneca Pty Ltd. | Import and supply | Over-the-counter medicines | ||
| liqnocaine hydrochloride (XYLOCAINE 4% TOPICAL) 40 mg/mL solution bottle (reformulation) | Aspen Pharmacare Australasia Pty Ltd | 124858 | CON-134 | 13 January 2017 until 30 June 2018. | 13/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels of medicines. | The products display the name and address of the old sponsor AstraZeneca Pty Ltd. | Import and supply | Over-the-counter medicines | ||
| Xyloproct Ointment Tube | Aspen Pharmacare Australasia Pty Ltd | 12033 | CON-134 | 13 January 2017 until 30 June 2018. | 13/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels of medicines. | The products display the name and address of the old sponsor AstraZeneca Pty Ltd. | Import and supply | Over-the-counter medicines | ||
| Xylocaine 2% JELLY tube | Aspen Pharmacare Australasia Pty Ltd | 12026 | CON-134 | 13 January 2017 until 30 June 2018. | 13/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels of medicines. | The products display the name and address of the old sponsor AstraZeneca Pty Ltd. | Import and supply | Over-the-counter medicines | ||
| lidocaine (lignocaine) (XYLOCAINE 10% PUMP SPRAY) 10 mg/100 uL dose spray solution pump actuated aerosol | Aspen Pharmacare Australasia Pty Ltd | 134540 | CON-134 | 13 January 2017 until 30 June 2018. | 13/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels of medicines. | The products display the name and address of the old sponsor AstraZeneca Pty Ltd. | Import and supply | Over-the-counter medicines | ||
| EMLA DERMAL PATCH Carton | Aspen Pharmacare Australasia Pty Ltd | 60820 | CON-134 | 13 January 2017 until 30 June 2018. | 13/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels of medicines. | The products display the name and address of the old sponsor AstraZeneca Pty Ltd. | Import and supply | Over-the-counter medicines | ||
| EMLA 5% cream tube | Aspen Pharmacare Australasia Pty Ltd | 12886 | CON-134 | 13 January 2017 until 30 June 2018. | 13/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels of medicines. | The products display the name and address of the old sponsor AstraZeneca Pty Ltd. | Import and supply | Over-the-counter medicines | ||
| Emla 5% (kit) cream | Aspen Pharmacare Australasia Pty Ltd | 12046 | CON-134 | 13 January 2017 until 30 June 2018. | 13/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels of medicines. | The products display the name and address of the old sponsor AstraZeneca Pty Ltd. | Import and supply | Over-the-counter medicines | ||
| Fluticasone+Salmeterol Cipla 250/25 fluticasone propionate/salmeterol (as xinafoate) 250/25 microgram inhalation pressurised aerosol can metered dose | Cipla Australia Pty Ltd | 267107 | CON-131 | The consent is effective from 15 January 2017 until 15 January 2018. | 15/01/2017 | British Pharmacopoeia monograph for Fluticasone and Salmeterol Pressurised Inhalation, Suspension. | The products do not comply with the related substances requirements. | The expiry limit for the single maximum unknown impurity of fluticasone proprionate will be NMT 0.3%, and The expiry limit for the single maximum unknown impurity of salmeterol will be NMT 0.3%, and The expiry limit for the total impurities of salmeterol will be NMT 0.8%. | Import and supply | Prescription medicines | |
| Fluticasone+Salmeterol Cipla 125/25 fluticasone propionate/salmeterol (as xinafoate) 125/25 microgram inhalation pressurised aerosol can metered dose | Cipla Australia Pty Ltd | 267106 | CON-131 | The consent is effective from 15 January 2017 until 15 January 2018. | 15/01/2017 | British Pharmacopoeia monograph for Fluticasone and Salmeterol Pressurised Inhalation, Suspension. | The products do not comply with the related substances requirements. | The expiry limit for the single maximum unknown impurity of fluticasone proprionate will be NMT 0.3%, and The expiry limit for the single maximum unknown impurity of salmeterol will be NMT 0.3%, and The expiry limit for the total impurities of salmeterol will be NMT 0.8%. | Import and supply | Prescription medicines | |
| SalplusF Inhaler 250/25 fluticasone propionate/salmeterol (as xinafoate) 250 microgram/25 microgram inhalation pressurised aerosol can metered dose | Cipla Australia Pty Ltd | 267105 | CON-131 | The consent is effective from 15 January 2017 until 15 January 2018. | 15/01/2017 | British Pharmacopoeia monograph for Fluticasone and Salmeterol Pressurised Inhalation, Suspension. | The products do not comply with the related substances requirements. | The expiry limit for the single maximum unknown impurity of fluticasone proprionate will be NMT 0.3%, and The expiry limit for the single maximum unknown impurity of salmeterol will be NMT 0.3%, and The expiry limit for the total impurities of salmeterol will be NMT 0.8%. | Import and supply | Prescription medicines | |
| SalplusF Inhaler 125/25 fluticasone propionate/salmeterol (as xinafoate) 125 microgram/25 microgram inhalation pressurised aerosol can metered dose | Cipla Australia Pty Ltd | 267104 | CON-131 | The consent is effective from 15 January 2017 until 15 January 2018. | 15/01/2017 | British Pharmacopoeia monograph for Fluticasone and Salmeterol Pressurised Inhalation, Suspension. | The products do not comply with the related substances requirements. | The expiry limit for the single maximum unknown impurity of fluticasone proprionate will be NMT 0.3%, and The expiry limit for the single maximum unknown impurity of salmeterol will be NMT 0.3%, and The expiry limit for the total impurities of salmeterol will be NMT 0.8%. | Import and supply | Prescription medicines | |
| Serroflo 250/25 fluticasone propionate/salmeterol (as xinafoate) 250 microgram/25 microgram inhalation pressurised aerosol can metered dose | Cipla Australia Pty Ltd | 267095 | CON-131 | The consent is effective from 15 January 2017 until 15 January 2018. | 15/01/2017 | British Pharmacopoeia monograph for Fluticasone and Salmeterol Pressurised Inhalation, Suspension. | The products do not comply with the related substances requirements. | The expiry limit for the single maximum unknown impurity of fluticasone proprionate will be NMT 0.3%, and The expiry limit for the single maximum unknown impurity of salmeterol will be NMT 0.3%, and The expiry limit for the total impurities of salmeterol will be NMT 0.8%. | Import and supply | Prescription medicines | |
| Serroflo125/25 fluticasone propionate/salmeterol (as xinafoate)125 microgram/25 microgram inhalation pressurised aerosol can metered dose | Cipla Australia Pty Ltd | 267092 | CON-131 | The consent is effective from 15 January 2017 until 15 January 2018. | 15/01/2017 | British Pharmacopoeia monograph for Fluticasone and Salmeterol Pressurised Inhalation, Suspension. | The products do not comply with the related substances requirements. | The expiry limit for the single maximum unknown impurity of fluticasone proprionate will be NMT 0.3%, and The expiry limit for the single maximum unknown impurity of salmeterol will be NMT 0.3%, and The expiry limit for the total impurities of salmeterol will be NMT 0.8%. | Import and supply | Prescription medicines | |
| aspirin (SPREN 100) 100 mg tablet bottle | Arrow Pharma Pty Ltd | 201237 | CON-135 | The consent is effective from the 25 January 2017 until 30 June 2017. | 25/01/2017 | Subclause 3(2)(g) and subclause 3(2)(l) of Therapeutic Goods Order 69 - General requirements for labels for medicines. | the product label does not include: all of the advisory statements specified in the instrument made by the Ministe runder subsection 3(5A) of the Act, or the name and address of the current sponsor or supplier of the goods. | the labels to which this consent applies are those previously approved by theTGA for the former sponsor, Aspen Pharma Pty Ltd, and arrangements are inplace with the former sponsor for the prompt referral of any queries of complaints concerning the products to Arrow Pharma Pty Ltd (the current sponsor). | Supply | Over-the-counter medicines | |
| pomalidomide (POMALYST) 4 mg capsule blister pack | Celgene Pty Ltd | 212655 | C2039AA, C2088AA and C2086BA | CON-136 | The consent is effective from the 30 January 2017 until 31 January 2019. | 30/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not bear the current address of the sponsor. | The labels to which this consent applies are those previously approved with the old sponsor address and arrangements are in place with Australia Post to forward any mail concerning these products received at the old address (level 7/607 St Kilda Road, Melbourne VIC 3004) to the new address (Level 15/60 City Road Southbank VIC 3006). | Supply | Prescription medicines |
| pomalidomide (POMALYST) 3 mg capsule blister pack | Celgene Pty Ltd | 212656 | C2038AA and C2038EA | CON-136 | The consent is effective from the 30 January 2017 until 31 January 2019. | 30/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not bear the current address of the sponsor. | The labels to which this consent applies are those previously approved with the old sponsor address and arrangements are in place with Australia Post to forward any mail concerning these products received at the old address (level 7/607 St Kilda Road, Melbourne VIC 3004) to the new address (Level 15/60 City Road Southbank VIC 3006). | Supply | Prescription medicines |
| pomalidomide (POMALYST) 2 mg capsule blister pack | Celgene Pty Ltd | 212654 | C0067HA and C2108BA | CON-136 | The consent is effective from the 30 January 2017 until 31 January 2019. | 30/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not bear the current address of the sponsor. | The labels to which this consent applies are those previously approved with the old sponsor address and arrangements are in place with Australia Post to forward any mail concerning these products received at the old address (level 7/607 St Kilda Road, Melbourne VIC 3004) to the new address (Level 15/60 City Road Southbank VIC 3006). | Supply | Prescription medicines |
| pomalidomide (POMALYST) 1 mg capsule blister pack | Celgene Pty Ltd | 212657 | C2021EA | CON-136 | The consent is effective from the 30 January 2017 until 31 January 2019. | 30/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not bear the current address of the sponsor. | The labels to which this consent applies are those previously approved with the old sponsor address and arrangements are in place with Australia Post to forward any mail concerning these products received at the old address (level 7/607 St Kilda Road, Melbourne VIC 3004) to the new address (Level 15/60 City Road Southbank VIC 3006). | Supply | Prescription medicines |
| azacitidine (VIDAZA) 100 mg powder for injection | Celgene Pty Ltd | 153080 | 5I810A, 5I812B and 6A845A | CON-136 | The consent is effective from the 30 January 2017 until 31 January 2019. | 30/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not bear the current address of the sponsor. | The labels to which this consent applies are those previously approved with the old sponsor address and arrangements are in place with Australia Post to forward any mail concerning these products received at the old address (level 7/607 St Kilda Road, Melbourne VIC 3004) to the new address (Level 15/60 City Road Southbank VIC 3006). | Supply | Prescription medicines |
| apremilast (OTEZLA TITRATION PACK) tablet blister pack | Celgene Pty Ltd | 220424 | H02048A | CON-136 | The consent is effective from the 30 January 2017 until 31 January 2019. | 30/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not bear the current address of the sponsor. | The labels to which this consent applies are those previously approved with the old sponsor address and arrangements are in place with Australia Post to forward any mail concerning these products received at the old address (level 7/607 St Kilda Road, Melbourne VIC 3004) to the new address (Level 15/60 City Road Southbank VIC 3006). | Supply | Prescription medicines |
| apremilast (OTEZLA) 30 mg film coated tablet blister pack | Celgene Pty Ltd | 220423 | F2076EA and F2115BA | CON-136 | The consent is effective from the 30 January 2017 until 31 January 2019. | 30/01/2017 | subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not bear the current address of the sponsor. | The labels to which this consent applies are those previously approved with the old sponsor address and arrangements are in place with Australia Post to forward any mail concerning these products received at the old address (level 7/607 St Kilda Road, Melbourne VIC 3004) to the new address (Level 15/60 City Road Southbank VIC 3006). | Supply | Prescription medicines |
| lactulose (DUPHALAC) 667 mg/ mL oral liquid | BGP Products Pty Ltd | 13295 | CON-144 | The consent is effective from the 2 February until 11 August 2017. | 2/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The product label does not include the name and address of the current sponsor and instead displays the details of the previous sponsor. | Supply | Over-the-counter medicines | ||
| ioversol (OPTIRAY 350) 74% w/v 148.2 g/200 mL injection vial | Guerbet Australia Pty Ltd | 49612 | 15D0925 | CON-139 | The consent is effective from 1 April 2017 until 30 September 2017 for AUST R: 51541, 51542, 46640, 46641, 73580, 46642, 51795, 20034, 49422, 49610, 47996, 47997. The consent is effective from 1 April 2017 until 31 March 2018 for AUST R: 49423, 47998, 49612. | 3/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | Theproduct labels state the Sponsor’s previous name. | The labels to which this consent applies are those previously approved for the former sponsor Mallinckrodt Australia Pty Ltd and the contact details of the current sponsor (Guerbet Australia Pty Ltd) remain the same as the former sponsor (Mallinckrodt Australia Pty Ltd) for receiving any queries or complaints concerning the products. | Import and supply | Prescription medicines |
| ioversol (OPTIRAY 350) 74% w/v 74.1 g/100 mL injection vial | Guerbet Australia Pty Ltd | 47998 | 16C0635, 16E1135 | CON-139 | The consent is effective from 1 April 2017 until 30 September 2017 for AUST R: 51541, 51542, 46640, 46641, 73580, 46642, 51795, 20034, 49422, 49610, 47996, 47997. The consent is effective from 1 April 2017 until 31 March 2018 for AUST R: 49423, 47998, 49612. | 3/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | Theproduct labels state the Sponsor’s previous name. | The labels to which this consent applies are those previously approved for the former sponsor Mallinckrodt Australia Pty Ltd and the contact details of the current sponsor (Guerbet Australia Pty Ltd) remain the same as the former sponsor (Mallinckrodt Australia Pty Ltd) for receiving any queries or complaints concerning the products. | Import and supply | Prescription medicines |
| ioversol (OPTIRAY 320) 67.8 g/100 mL injection vial | Guerbet Australia Pty Ltd | 49423 | 15F1375 | CON-139 | The consent is effective from 1 April 2017 until 30 September 2017 for AUST R: 51541, 51542, 46640, 46641, 73580, 46642, 51795, 20034, 49422, 49610, 47996, 47997. The consent is effective from 1 April 2017 until 31 March 2018 for AUST R: 49423, 47998, 49612. | 3/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | Theproduct labels state the Sponsor’s previous name. | The labels to which this consent applies are those previously approved for the former sponsor Mallinckrodt Australia Pty Ltd and the contact details of the current sponsor (Guerbet Australia Pty Ltd) remain the same as the former sponsor (Mallinckrodt Australia Pty Ltd) for receiving any queries or complaints concerning the products. | Import and supply | Prescription medicines |
| ioversol (OPTIRAY 350) 74% w/v 55.575 g/75 mL injection vial | Guerbet Australia Pty Ltd | 47997 | 16C0635, 16D1135 | CON-139 | The consent is effective from 1 April 2017 until 30 September 2017 for AUST R: 51541, 51542, 46640, 46641, 73580, 46642, 51795, 20034, 49422, 49610, 47996, 47997. The consent is effective from 1 April 2017 until 31 March 2018 for AUST R: 49423, 47998, 49612. | 3/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | Theproduct labels state the Sponsor’s previous name. | The labels to which this consent applies are those previously approved for the former sponsor Mallinckrodt Australia Pty Ltd and the contact details of the current sponsor (Guerbet Australia Pty Ltd) remain the same as the former sponsor (Mallinckrodt Australia Pty Ltd) for receiving any queries or complaints concerning the products. | Import and supply | Prescription medicines |
| ioversol (OPTIRAY 350) 74% w/v 37.05 g/50 mL injection vial | Guerbet Australia Pty Ltd | 47996 | 16F1555 | CON-139 | The consent is effective from 1 April 2017 until 30 September 2017 for AUST R: 51541, 51542, 46640, 46641, 73580, 46642, 51795, 20034, 49422, 49610, 47996, 47997. The consent is effective from 1 April 2017 until 31 March 2018 for AUST R: 49423, 47998, 49612. | 3/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | Theproduct labels state the Sponsor’s previous name. | The labels to which this consent applies are those previously approved for the former sponsor Mallinckrodt Australia Pty Ltd and the contact details of the current sponsor (Guerbet Australia Pty Ltd) remain the same as the former sponsor (Mallinckrodt Australia Pty Ltd) for receiving any queries or complaints concerning the products. | Import and supply | Prescription medicines |
| ioversol (OPTIRAY 350) 74% w/v 14.82 g/20 mL injection vial | Guerbet Australia Pty Ltd | 49610 | 15C0685 | CON-139 | The consent is effective from 1 April 2017 until 30 September 2017 for AUST R: 51541, 51542, 46640, 46641, 73580, 46642, 51795, 20034, 49422, 49610, 47996, 47997. The consent is effective from 1 April 2017 until 31 March 2018 for AUST R: 49423, 47998, 49612. | 3/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | Theproduct labels state the Sponsor’s previous name. | The labels to which this consent applies are those previously approved for the former sponsor Mallinckrodt Australia Pty Ltd and the contact details of the current sponsor (Guerbet Australia Pty Ltd) remain the same as the former sponsor (Mallinckrodt Australia Pty Ltd) for receiving any queries or complaints concerning the products. | Import and supply | Prescription medicines |
| ioversol (OPTIRAY 320) 33.9 g/50 mL injection vial | Guerbet Australia Pty Ltd | 49422 | 16F1325 | CON-139 | The consent is effective from 1 April 2017 until 30 September 2017 for AUST R: 51541, 51542, 46640, 46641, 73580, 46642, 51795, 20034, 49422, 49610, 47996, 47997. The consent is effective from 1 April 2017 until 31 March 2018 for AUST R: 49423, 47998, 49612. | 3/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | Theproduct labels state the Sponsor’s previous name. | The labels to which this consent applies are those previously approved for the former sponsor Mallinckrodt Australia Pty Ltd and the contact details of the current sponsor (Guerbet Australia Pty Ltd) remain the same as the former sponsor (Mallinckrodt Australia Pty Ltd) for receiving any queries or complaints concerning the products. | Import and supply | Prescription medicines |
| ioversol (OPITIARY 320) 13.56 g/20 mL injection vial | Guerbet Australia Pty Ltd | 20034 | 16D0985 | CON-139 | The consent is effective from 1 April 2017 until 30 September 2017 for AUST R: 51541, 51542, 46640, 46641, 73580, 46642, 51795, 20034, 49422, 49610, 47996, 47997. The consent is effective from 1 April 2017 until 31 March 2018 for AUST R: 49423, 47998, 49612. | 3/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | Theproduct labels state the Sponsor’s previous name. | The labels to which this consent applies are those previously approved for the former sponsor Mallinckrodt Australia Pty Ltd and the contact details of the current sponsor (Guerbet Australia Pty Ltd) remain the same as the former sponsor (Mallinckrodt Australia Pty Ltd) for receiving any queries or complaints concerning the products. | Import and supply | Prescription medicines |
| ioversol (OPTIRAY 350 ULTRAJECT) 74% w/v 22.23 g/30 mL injection syringe | Guerbet Australia Pty Ltd | 51795 | 15F1442 | CON-139 | The consent is effective from 1 April 2017 until 30 September 2017 for AUST R: 51541, 51542, 46640, 46641, 73580, 46642, 51795, 20034, 49422, 49610, 47996, 47997. The consent is effective from 1 April 2017 until 31 March 2018 for AUST R: 49423, 47998, 49612. | 3/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | Theproduct labels state the Sponsor’s previous name. | The labels to which this consent applies are those previously approved for the former sponsor Mallinckrodt Australia Pty Ltd and the contact details of the current sponsor (Guerbet Australia Pty Ltd) remain the same as the former sponsor (Mallinckrodt Australia Pty Ltd) for receiving any queries or complaints concerning the products. | Import and supply | Prescription medicines |
| ioversol (OPTIRAY 320) 678 mg/mL 125 mL injection syringe (power injector) | Guerbet Australia Pty Ltd | 46642 | 16E1212, 16J2422 | CON-139 | The consent is effective from 1 April 2017 until 30 September 2017 for AUST R: 51541, 51542, 46640, 46641, 73580, 46642, 51795, 20034, 49422, 49610, 47996, 47997. The consent is effective from 1 April 2017 until 31 March 2018 for AUST R: 49423, 47998, 49612. | 3/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | Theproduct labels state the Sponsor’s previous name. | The labels to which this consent applies are those previously approved for the former sponsor Mallinckrodt Australia Pty Ltd and the contact details of the current sponsor (Guerbet Australia Pty Ltd) remain the same as the former sponsor (Mallinckrodt Australia Pty Ltd) for receiving any queries or complaints concerning the products. | Import and supply | Prescription medicines |
| ioversol (OPTIRAY 320 ULTRAJECT) 50.8 g/75 mL injection syringe | Guerbet Australia Pty Ltd | 73580 | 16F1572, 16J2422, 16G1842 | CON-139 | The consent is effective from 1 April 2017 until 30 September 2017 for AUST R: 51541, 51542, 46640, 46641, 73580, 46642, 51795, 20034, 49422, 49610, 47996, 47997. The consent is effective from 1 April 2017 until 31 March 2018 for AUST R: 49423, 47998, 49612. | 3/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | Theproduct labels state the Sponsor’s previous name. | The labels to which this consent applies are those previously approved for the former sponsor Mallinckrodt Australia Pty Ltd and the contact details of the current sponsor (Guerbet Australia Pty Ltd) remain the same as the former sponsor (Mallinckrodt Australia Pty Ltd) for receiving any queries or complaints concerning the products. | Import and supply | Prescription medicines |
| ioversol (OPTIRAY 320) 678 mg/mL 50 mL injection syringe | Guerbet Australia Pty Ltd | 46641 | 16E1122, 15F1372 | CON-139 | The consent is effective from 1 April 2017 until 30 September 2017 for AUST R: 51541, 51542, 46640, 46641, 73580, 46642, 51795, 20034, 49422, 49610, 47996, 47997. The consent is effective from 1 April 2017 until 31 March 2018 for AUST R: 49423, 47998, 49612. | 3/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | Theproduct labels state the Sponsor’s previous name. | The labels to which this consent applies are those previously approved for the former sponsor Mallinckrodt Australia Pty Ltd and the contact details of the current sponsor (Guerbet Australia Pty Ltd) remain the same as the former sponsor (Mallinckrodt Australia Pty Ltd) for receiving any queries or complaints concerning the products. | Import and supply | Prescription medicines |
| ioversol (OPTIRAY 240) 636.25 g/125 mL injection syringe | Guerbet Australia Pty Ltd | 46640 | 15G1662 | CON-139 | The consent is effective from 1 April 2017 until 30 September 2017 for AUST R: 51541, 51542, 46640, 46641, 73580, 46642, 51795, 20034, 49422, 49610, 47996, 47997. The consent is effective from 1 April 2017 until 31 March 2018 for AUST R: 49423, 47998, 49612. | 3/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | Theproduct labels state the Sponsor’s previous name. | The labels to which this consent applies are those previously approved for the former sponsor Mallinckrodt Australia Pty Ltd and the contact details of the current sponsor (Guerbet Australia Pty Ltd) remain the same as the former sponsor (Mallinckrodt Australia Pty Ltd) for receiving any queries or complaints concerning the products. | Import and supply | Prescription medicines |
| iotalamate meglumine (CONRAY-280) 30 g/50 mL injection vial | Guerbet Australia Pty Ltd | 51542 | 15F1365, 16A0135 | CON-139 | The consent is effective from 1 April 2017 until 30 September 2017 for AUST R: 51541, 51542, 46640, 46641, 73580, 46642, 51795, 20034, 49422, 49610, 47996, 47997. The consent is effective from 1 April 2017 until 31 March 2018 for AUST R: 49423, 47998, 49612. | 3/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | Theproduct labels state the Sponsor’s previous name. | The labels to which this consent applies are those previously approved for the former sponsor Mallinckrodt Australia Pty Ltd and the contact details of the current sponsor (Guerbet Australia Pty Ltd) remain the same as the former sponsor (Mallinckrodt Australia Pty Ltd) for receiving any queries or complaints concerning the products. | Import and supply | Prescription medicines |
| iotalamate meglumine (CONRAY 280) 12 g/ 20 mL injection vial | Guerbet Australia Pty Ltd | 51541 | 15F1365 | CON-139 | The consent is effective from 1 April 2017 until 30 September 2017 for AUST R: 51541, 51542, 46640, 46641, 73580, 46642, 51795, 20034, 49422, 49610, 47996, 47997. The consent is effective from 1 April 2017 until 31 March 2018 for AUST R: 49423, 47998, 49612. | 3/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | Theproduct labels state the Sponsor’s previous name. | The labels to which this consent applies are those previously approved for the former sponsor Mallinckrodt Australia Pty Ltd and the contact details of the current sponsor (Guerbet Australia Pty Ltd) remain the same as the former sponsor (Mallinckrodt Australia Pty Ltd) for receiving any queries or complaints concerning the products. | Import and supply | Prescription medicines |
| istodax (romidepsin) 10 mg powder for injection vial, and solvent for reconstitution vial | Celgene Pty Ltd | 198854 | 4D016C and 5F019C | CON-138 | The consent is effective from 8 February 2017 until 8 February 2019 or the batches are exhausted, whichever is sooner. | 8/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 — General requirements for labels for medicines. | The product labels state the previous address of the sponsor. | Arrangements are in place to communicate the address change and to forward all communication to the current address. | Import and supply | Prescription medicines |
| thalidomide (THALOMID) 100 mg hard capsule blister pack | Celgene Pty Ltd | 156902 | B2006-02, B2006-05, B0029-04, B2006-07 | CON-138 | The consent is effective from 8 February 2017 until 8 February 2019 or the batches are exhausted, whichever is sooner. | 8/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 — General requirements for labels for medicines. | The product labels state the previous address of the sponsor. | Arrangements are in place to communicate the address change and to forward all communication to the current address. | Import and supply | Prescription medicines |
| thalidomide (THALOMID) 50 mg hard capsule blister pack | Celgene Pty Ltd | 156729 | B2004-05, B2004-08, B2004-02, and B2004-09 | CON-138 | The consent is effective from 8 February 2017 until 8 February 2019 or the batches are exhausted, whichever is sooner. | 8/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 — General requirements for labels for medicines. | The product labels state the previous address of the sponsor. | Arrangements are in place to communicate the address change and to forward all communication to the current address. | Import and supply | Prescription medicines |
| lenalidomide (REVLIMID) 25 mg capsule blister pack | Celgene Pty Ltd | 132516 | A0569FA, A2175EA, A2222AB, A2222AC, A2297AA, A2222AA | CON-138 | The consent is effective from 8 February 2017 until 8 February 2019 or the batches are exhausted, whichever is sooner. | 8/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 — General requirements for labels for medicines. | The product labels state the previous address of the sponsor. | Arrangements are in place to communicate the address change and to forward all communication to the current address. | Import and supply | Prescription medicines |
| lenalidomide (REVLIMID) 15 mg capsule blister pack | Celgene Pty Ltd | 132515 | A0616CC, A2070BB, A2138CB, A2139BA, A2270BA, A2070BA, and A2138CA | CON-138 | The consent is effective from 8 February 2017 until 8 February 2019 or the batches are exhausted, whichever is sooner. | 8/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 — General requirements for labels for medicines. | The product labels state the previous address of the sponsor. | Arrangements are in place to communicate the address change and to forward all communication to the current address. | Import and supply | Prescription medicines |
| lenalidomide (REVLIMID) 10 mg capsule blister pack | Celgene Pty Ltd | 132514 | A2120BA, A2161AA, A2234CA, A2266BA, and A2120BB | CON-138 | The consent is effective from 8 February 2017 until 8 February 2019 or the batches are exhausted, whichever is sooner. | 8/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 — General requirements for labels for medicines. | The product labels state the previous address of the sponsor. | Arrangements are in place to communicate the address change and to forward all communication to the current address. | Import and supply | Prescription medicines |
| lenalidomide (REVLIMID) 5 mg capsule blister pack | Celgene Pty Ltd | 132510 | A04831C, A0585BB, A2058BA, A2058BB, A0483FB, and A2229BA | CON-138 | The consent is effective from 8 February 2017 until 8 February 2019 or the batches are exhausted, whichever is sooner. | 8/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 — General requirements for labels for medicines. | The product labels state the previous address of the sponsor. | Arrangements are in place to communicate the address change and to forward all communication to the current address. | Import and supply | Prescription medicines |
| Honey and Lemon Flavour (SOOTHERS) | Nestlé Australia Ltd | 281103 | CON-137 | The consent is effective from 9 February 2017 letter until 9 February 2019. | 9/02/2017 | Subclause 3(12)(a) of Therapeutic Goods Order No. 69 — General requirements for labels for medicines. | The product name, the names of the active ingredients or the quantities of the active ingredients in the goods do not appear on each individual unsealed wrapper (subclause 3(12)(a)). | The lozenges which are individually wrapped in an unsealed, protective cover are enclosed in a primary pack that includes the particulars referred to in subclauses 3(2) and 3(3) of the Therapeutic Goods Order No. 69 — General requirements for labels for medicines. | Supply | Listed complementary medicines | |
| abciximab (REOPRO) 10 mg/ 5 ml injection vial | Janssen-Cilag Pty Ltd | 48864 | CON-142 | The consent is effective from 13 February 2017 until 1 February 2018. | 13/02/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. Section 8(1)(i) of the Therapeutic Goods Order No 91 – Standard for labels of prescription and related medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the former sponsor, Eli Lilly, and arrangements are in place with the former sponsor for the prompt referral of any queries / requests in relation to stock. This will also be highlighted in communications to customers advising of the product transfer and to send any queries about the product to Janssen-Cilag. | Import and supply | Prescription medicines | |
| abatacept (rch) (ORENCIA) 125 mg single dose ClickJect Prefilled Autoinjector | Bristol-Myers Squibb Australia Pty Ltd | 236039 | AAN1249 | CON-141 | The consent is effective from 16 February 2017 until 16 February 2018. | 16/02/2017 | Subclause 3(2)(n)(i) of Therapeutic Goods Oder No 69 – General requirements for labels for medicines. Section 7(2)(d)(i) of Therapeutic Goods Oder No 91 – Standard for labels of prescription and related medicines. | The"AUST R" was inadvertently spelt "AUT R" on the carton artwork only. | This consent applies only to the labels of 1079 units of one batch (AAN1249) of ORENCIA expected to be consumed within 7 months. The expected timeline for depletion of the non-complaint batch is dependent upon launch time which is planned for 1 April 2017. This consent applies only to misspelling AUST R and not the actual AUST R number which is correct on the carton label. | Supply | Prescription medicines |
| Specialist Energy Plus (CENTRUM) | Pfizer Consumer Healthcare | 224847 | R90729 | CON-140 | The consent is effective from 16 February 2017 until 30 November 2018. | 16/02/2017 | Section 10(b) of the Therapeutic Goods Order No. 78 – Standards for Tablets and Capsules. | The content of the active ingredient 'Panax ginseng standardised root extract' (the herbal active ingredient) is more than 120.0% of the stated content on the label. | The content of the herbal active ingredient, 'Panax ginseng standardised root extract' must not be less than 90.0% and not more than 145.0% of the stated content of the label. | Import and supply | Listed complementary medicines |
| LifePak, LifePak Prime | Nu Skin Enterprises Australia Inc | 277347 283364 | CON-151 | The consent is effective from the 17 February 2017 until 31 August 2020, which is the end of the transition period from TGO 69 to TGO 92. After 31 August 2020, the product must comply with the new labelling order TGO92. | 17/02/2017 | Paragraph 3(12)(b) of Therapeutic Goods Order no. 69- General requirements for labels for medicines. | The names of the active ingredients or the quantities of the active ingredients in the goods do not appear on each individual dose sachets as per the requirements specified inparagraph 3(2)(b) & (c). | The individual dose sachets with capsules are individually sealed and enclosed in a primary pack that includes the particulars referred to in subclauses 3(2) and 3(3) of the TGO 69. | Import and supply | Listed complementary medicines | |
| catridecacog (rys) (NOVOTHIRTEEN) 2500 IU powder for injection vial with diluent vial | Novo Nordisk Pharmaceuticals Pty Ltd | 201776 | CON-147 | The consent is effective from 22 February 2017 until 21 February 2019. | 22/02/2017 | Section 10(4)(h) and (i) of Therapeutic Goods Order No 91 — Standard for labels of prescription and related medicines. | The powder and solvent vial labels include batch number and expiry date in a font size less than the minimum 1.5 millimetres (actual font size is 1.32 millimetres). In addition, the powder vial label will contain GTIN barcode in 1.32 millimetre font. | This consent applies to labels of the first supply of the product planned for July 2017 which, due to limitation of the packaging line, the batch number and expiry date cannot be printed in a larger font size. | Import and supply | Prescription medicines | |
| GRAZAX standardised allergen extract of grass pollen from Timothy grass (Phleum pratense) 75,000 SQ-T oral lyophilisate tablets blister foil | Seqirus Pty Ltd | 267955 | CON-221 | The consent is effective from 24 February 2017 until 1 March 2020. | 24/02/2017 | Subclause 3(2)(b), 3(2)(l) 3(13)(a) of the Therapeutic Goods Order No. 69- General requirements for labels for medicine | The proposed blister foil for the 75,000 SQ-T tablets does not include the name of the active ingredient (Phleum pratense); and the Seqirus name or trademark. | The ‘blister foil for the 75,000 SQ-T tablets’ labels to which the consent applies are those provided with the responses to S31-PM-2015-03979-1-2 (dated 30 August 2016). | Import and supply | Prescription medicines | |
| verapamil hydrochloride (ISOPTIN) 5 mg/ 2 mL injection ampoule | BGP Products Pty Ltd | 12796 | CON-143 | The consent is effective from 1 March 2017 until 11 August 2017. | 1/03/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels bear the former sponsor’s name/logo. | The labels to which this consent applies are those previously approved for the former sponsor Abbott Australasia Pty Ltd, which the carton labels will be over-stickered with current sponsor name and address. Arrangements are in place with the former sponsor Abbott Australasia Pty Ltd that correspondence concerning the affected products will be re-directed to the current sponsor BGP Products Pty Ltd. | Supply | Prescription medicines | |
| fluvoxamine maleate (LUVOX) 50 mg tablet blister pack | BGP Products Pty Ltd | 57632 | CON-143 | The consent is effective from 1 March 2017 until 11 August 2017. | 1/03/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels bear the former sponsor’s name/logo. | The labels to which this consent applies are those previously approved for the former sponsor Abbott Australasia Pty Ltd, which the carton labels will be over-stickered with current sponsor name and address. Arrangements are in place with the former sponsor Abbott Australasia Pty Ltd that correspondence concerning the affected products will be re-directed to the current sponsor BGP Products Pty Ltd. | Supply | Prescription medicines | |
| trandolapril (GOPTEN) 2 mg capsules blister pack | BGP Products Pty Ltd | 45457 | CON-143 | The consent is effective from 1 March 2017 until 11 August 2017. | 1/03/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels bear the former sponsor’s name/logo. | The labels to which this consent applies are those previously approved for the former sponsor Abbott Australasia Pty Ltd, which the carton labels will be over-stickered with current sponsor name and address. Arrangements are in place with the former sponsor Abbott Australasia Pty Ltd that correspondence concerning the affected products will be re-directed to the current sponsor BGP Products Pty Ltd. | Supply | Prescription medicines | |
| fomepizole (ANTIZOL) 1.5 g/ 1.5 mL concentrated injection vial | AFT Pharmaceuticals | 263913 | CON-145 | The consent is effective from the 2 March 2017 until 2 March 2018. | 2/03/2017 | Subclauses 3(2)(g), 7(1), 3(2)(j), 4(7)(c), 3(5)(a)(i), 3(5)(b)(ii), 3(2)(e), 3(5)(b)(i), 3(2)(c) and 3(11) and clauses 4, 5 and 7 of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The product carton labels lack appropriate warning statements; storage conditions are not set out as approved; a quantity of mg/mL is included; the route of administration is not on the main label; the presence of a preservative is not stated; the dosage form name is incomplete [should be concentrated injection]; the excipients present and their quantity is not stated; the statement of quantity of the active is not as approved. For the vial labels, a quantity of mg/mL is included; the dosage form name is incomplete [should be concentrated injection]; and the Australian sponsor's name or trade mark is missing. | A 'Dear Healthcare Provider' letter identical to that provided to the TGA in the correspondence dated 24 February [TGA reference D17-161719] will be supplied with each affected batch, setting out the circumstances of the section 14 consent and other matters relating to safe use of the product; The labels to which this consent applies are those supplied with the correspondence date 3 February 2017, and the carton labels will be overstickered with the AUST R number, Australian sponsor address details, the batch number and the correct Australian expiry date as agreed in the correspondence. | Import and supply | Prescription medicines | |
| clevidipine (CLEVIPREX ) 25 mg in 50 mL injectable emulsion single use vials | Emerge Health Pty Ltd | 203313 | CON-146 | The consent is effective from the 7 March 2017 until 31 December 2018. | 7/03/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 — General requirements for labels for medicines. | The outer carton, inner carton and vial labels bear the former sponsor’s name and address. | The labels (outer carton, inner carton and vial labels) to which this consent applies are those previously approved for the former sponsor The Medicine Company (Australia) Pty Ltd. Arrangements are in place with the former sponsor The Medicine Company (Australia) Pty Ltd that correspondence concerning this product will be forwarded to the current sponsor Emerge Health Pty Ltd. | Supply | Prescription medicines | |
| oral typhoid vaccine (VIVOTIF ORAL) capsule blister pack | Seqirus Pty Ltd | 158130 | 3003182, 3003162 and 3003173 | CON-148 | The consent is effective from 10 March 2017 until 31 August 2018. | 10/03/2017 | Clause 3(2)(l) of Therapeutic Goods Order No. 69 – general requirements for medicines. | The carton and leaflet do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the former sponsor CSL Ltd, and arrangements are in place with the former sponsor CSL Ltd for the prompt referral or any queries or complaints concerning the products to Seqirus Pty Ltd. | Import and supply | Prescription medicines |
| oxymetazoline hydrochloride (PHARMACY ACTION NASAL DECONGESTANT) 0.5 mg/mL spray solution bottle | Generic Health Pty Ltd | 189039 | 48186 | CON-149 | The consent is effective from 15 March 2017 until batch number 48186 has expired. | 15/03/2017 | Paragraph 3(2)(g) of the Therapeutic Goods Order No. 69 - General requirements for medicines. | The product label does not include the advisory statement 'Frequent or prolonged use may cause nasal congestion to recur or worsen.' | Import and supply | Over-the-counter medicines | |
| QUADRACEL 0.5 mL injection vial | Sanofi Aventis Australia Pty Ltd | 91355 | C5020AA - expiry 28 February 2018 C5222AC - expiry 30 November 2018 | CON-150 | The consent is effective from the 16 March 2017 until the expiry date of the batches, on 28 February 2018 (batch C5020AA) and 30 November 2018 (batch C5222AC) | 16/03/2017 | The product does not conform to the requirements of the European Pharmacopoeia. | It is tested to the United States rather than Australian specifications. | 1. This consent applies only to 30000 doses from Quadracel batch C5020AA and 60000 doses from batch C5222AC 2. Non”compliance with the European Pharmacopoeia requirements is limited to the tests detailed in the application 3. The doses will be labelled in the Australian approved labels (carton, vial and package insert) 4. The company will provide TGA with a copy of the Release Certificate of the relevant bulk from US CBER 5. Normal TGA batch release processes will apply to this batch | Import and supply | Prescription medicines |
| mebeverine hydrochloride (COLOFAC) 135 mg tablet blister pack | Mylan EPD | 79335 | CON-153 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000) | Supply | Prescription medicines | |
| lercanidipine hydrochloride (ZANIDIP) 20 mg film coated tablet blister pack | Mylan EPD | 93733 | CON-153 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000) | Supply | Prescription medicines | |
| lercanidipine hydrochloride (ZANIDIP) 10 mg film coated tablet blister pack | Mylan EPD | 77506 | CON-153 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000) | Supply | Prescription medicines | |
| lercanidipine hydrochloride (LERCANIDIPINE SANDOZ) 20 mg film coated tablet blister pack | Mylan EPD | 165914 | CON-153 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000) | Supply | Prescription medicines | |
| lercanidipine hydrochloride (LERCANIDIPINE SANDOZ) 10 mg film coated tablet blister pack | Mylan EPD | 165913 | CON-153 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000) | Supply | Prescription medicines | |
| Omega-3-acid ethyl esters 90 (OMACOR) 1000 mg soft capsule bottle | Mylan EPD | 155717 | CON-153 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000) | Supply | Prescription medicines | |
| lercanidipine hydrochloride (LERCADIP) 20 mg tablet blister pack | Mylan EPD | 152710 | CON-153 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000) | Supply | Prescription medicines | |
| lercanidipine hydrochloride (LERCADIP) 10 mg tablet blister pack | Mylan EPD | 152709 | CON-153 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000) | Supply | Prescription medicines | |
| lercanidipine hydrochloride (LERCAN) 20 mg tablet blister pack | Mylan EPD | 152708 | CON-153 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000) | Supply | Prescription medicines | |
| lercanidipine hydrochloride (LERCAN) 10 mg tablet blister pack | Mylan EPD | 152707 | CON-153 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000) | Supply | Prescription medicines | |
| lercanidipine hydrochloride/enalapril maleate (ZAN-EXTRA 10/20) 10 mg/20 mg film coated tablets blister pack | Mylan EPD | 120961 | CON-153 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000) | Supply | Prescription medicines | |
| lercanidipine hydrochloride/enalapril maleate (ZAN-EXTRA 10/10) 10 mg/10 mg film coated tablets blister pack | Mylan EPD | 120955 | CON-153 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000) | Supply | Prescription medicines | |
| moxonidine (NORMATENS) 400 microgram tablet blister pack | Mylan EPD | 114124 | CON-153 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000) | Supply | Prescription medicines | |
| moxonidine (NORMATENS) 200 microgram tablet blister pack | Mylan EPD | 114122 | CON-153 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000) | Supply | Prescription medicines | |
| moxonidine (PHYSIOTENS) 400 microgram tablet blister pack | Mylan EPD | 114121 | CON-153 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000) | Supply | Prescription medicines | |
| moxonidine (PHYSIOTENS) 200 microgram tablet blister pack | Mylan EPD | 114119 | CON-153 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000) | Supply | Prescription medicines | |
| FEMOSTON-CONTI tablet blister pack | Mylan EPD | 78654 | CON-152 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| FEMOSTON 2/10 estradiol 2 mg and estradiol 2 mg with dydrogesterone 10 mg tablet blister pack composite pack | Mylan EPD | 75889 | CON-152 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| FEMOSTON 1/10 estradiol 1 mg and estradiol 1 mg with dydrogesterone 10 mg tablet blister pack composite pack | Mylan EPD | 219882 | CON-152 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| clarithromycin (KLACID) 250 mg/5 mL powder for oral liquid bottle | Mylan EPD | 56729 | CON-152 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| clarithromycin (KLACID) 250 mg tablet blister pack | Mylan EPD | 79564 | CON-152 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| clarithromycin (KLACID) 250 mg tablet bottle | Mylan EPD | 79576 | CON-152 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| clarithromycin (KLACID) 500 mg tablet blister pack | Mylan EPD | 52473 | CON-152 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| clarithromycin (KLACID) 500 mg tablet bottle | Mylan EPD | 50682 | CON-152 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| Betahistine dihydrochloride (SERC) 16 mg tablet blister pack | Mylan EPD | 61687 | CON-152 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| verapamil hydrochloride (ISOPTIN SR) 240 mg tablet blister pack | Mylan EPD | 12801 | CON-152 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| verapamil hydrochloride (ISOPTIN 180 SR) 180 mg tablet blister pack | Mylan EPD | 54032 | CON-152 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| verapamil hydrochloride (ISOPTIN) 80 mg tablet blister pack | Mylan EPD | 65503 | CON-152 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| verapamil hydrochloride (ISOPTIN) 40 mg tablet blister pack | Mylan EPD | 65502 | CON-152 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| verapamil hydrochloride (ISOPTIN) 5 mg/2 mL injection ampoule | Mylan EPD | 12796 | CON-152 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| verapamil hydrochloride (CORDILOX 180 SR) 180 mg tablet blister pack | Mylan EPD | 54033 | CON-152 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| verapamil hydrochloride (CORDILOX SR) 240 mg tablet blister pack | Mylan EPD | 10681 | CON-152 | The consent is effective from the 27 March 2017 until 10 October 2018. | 27/03/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| pancreatic extract (CREON 40,000) 400 mg capsules of enteric-coated minimicropsheres bottle | BGP Products Pty Ltd | 158451 | CON-154 | The consent is effective from 29 March 2017 until 10 October 2018. | 29/03/2017 | Paragraph 3(2)(l) of Therapeutics Goods Order No. 69 - General requirements for labels for medicines. | The current address of the sponsor or supplier of the goods is not on the labels. Instead the labels contain the former address of the sponsor (BGP Products Pty Ltd). | The labels to which this consent applies are those previously approved for CREON products listed above from the sponsor BGP Products Pty Ltd and arrangements are in place for any queries/requests to be redirected to the new address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| pancreatic extract (CREON 25,000) 300 mg capsule bottle | BGP Products Pty Ltd | 158452 | CON-154 | The consent is effective from 29 March 2017 until 10 October 2018. | 29/03/2017 | Paragraph 3(2)(l) of Therapeutics Goods Order No. 69 - General requirements for labels for medicines. | The current address of the sponsor or supplier of the goods is not on the labels. Instead the labels contain the former address of the sponsor (BGP Products Pty Ltd). | The labels to which this consent applies are those previously approved for CREON products listed above from the sponsor BGP Products Pty Ltd and arrangements are in place for any queries/requests to be redirected to the new address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| pancreatic extract (CREON 10,000) 150 mg capsules of enteric-coated minimicrospheres bottle | BGP Products Pty Ltd | 158453 | CON-154 | The consent is effective from 29 March 2017 until 10 October 2018. | 29/03/2017 | Paragraph 3(2)(l) of Therapeutics Goods Order No. 69 - General requirements for labels for medicines. | The current address of the sponsor or supplier of the goods is not on the labels. Instead the labels contain the former address of the sponsor (BGP Products Pty Ltd). | The labels to which this consent applies are those previously approved for CREON products listed above from the sponsor BGP Products Pty Ltd and arrangements are in place for any queries/requests to be redirected to the new address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| pancreatic extract (CREON MICRO) 20 g enteric coated granules bottle | BGP Products Pty Ltd | 166118 | CON-154 | The consent is effective from 29 March 2017 until 10 October 2018. | 29/03/2017 | Paragraph 3(2)(l) of Therapeutics Goods Order No. 69 - General requirements for labels for medicines. | The current address of the sponsor or supplier of the goods is not on the labels. Instead the labels contain the former address of the sponsor (BGP Products Pty Ltd). | The labels to which this consent applies are those previously approved for CREON products listed above from the sponsor BGP Products Pty Ltd and arrangements are in place for any queries/requests to be redirected to the new address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| tigecycline (TYGACYCLINE) 50 mg Powder for injection Glass vial | Neo Health (Australia) Pty Ltd | 275814 | CON-157 | This consent is effective from 7 April 2017 until 7 October 2018. | 7/04/2017 | The requirements of the United States Pharmacopeia monograph Tigecycline for Injection. | The goods do not need to comply with the limit applied to the specified impurity tigecycline epimer. | The expiry limit for the tigecycline epimer will be NMT 2.5%. | Import and supply | Prescription medicines | |
| tigecycline (TYGALINE) 50 mg Powder for injection Glass vial | Neo Health (Australia) Pty Ltd | 275813 | CON-157 | This consent is effective from 7 April 2017 until 7 October 2018. | 7/04/2017 | The requirements of the United States Pharmacopeia monograph Tigecycline for Injection. | The goods do not need to comply with the limit applied to the specified impurity tigecycline epimer. | The expiry limit for the tigecycline epimer will be NMT 2.5%. | Import and supply | Prescription medicines | |
| tigecycline (TIGECYCLE) 50 mg Powder for injection Glass vial | Neo Health (Australia) Pty Ltd | 275812 | CON-157 | This consent is effective from 7 April 2017 until 7 October 2018. | 7/04/2017 | The requirements of the United States Pharmacopeia monograph Tigecycline for Injection. | The goods do not need to comply with the limit applied to the specified impurity tigecycline epimer. | The expiry limit for the tigecycline epimer will be NMT 2.5%. | Import and supply | Prescription medicines | |
| tigecycline (TIGECYCLINE JUNO) 50 mg Powder for injection Glass vial | Neo Health (Australia) Pty Ltd | 275811 | CON-157 | This consent is effective from 7 April 2017 until 7 October 2018. | 7/04/2017 | The requirements of the United States Pharmacopeia monograph Tigecycline for Injection. | The goods do not need to comply with the limit applied to the specified impurity tigecycline epimer. | The expiry limit for the tigecycline epimer will be NMT 2.5%. | Import and supply | Prescription medicines | |
| ibuprofen (BRUFEN) 400 mg tablet blister pack | Mylan EPD | 80659 | CON-156 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| eprosartan (TEVETEN) 600 mg (as mesilate) tablet blister pack | Mylan EPD | 73779 | CON-156 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| eprosartan (TEVETEN) 400 mg (as mesilate) tablet blister pack | Mylan EPD | 64400 | CON-156 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| fluvoxamine maleate (LUVOX) 100 mg tablet blister pack | Mylan EPD | 57633 | CON-156 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| fluvoxamine maleate (LUVOX) 50 mg tablet blister pack | Mylan EPD | 57632 | CON-156 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| fenofibrate (TRICHODIL) 48 mg tablet blister pack | Mylan EPD | 233991 | CON-156 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| fenofibrate (TRICHODIL) 145 mg tablet blister pack | Mylan EPD | 233990 | CON-156 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| fenofibrate (FENOFIB) 48 mg tablet blister pack | Mylan EPD | 233989 | CON-156 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| fenofibrate (FENOFIB) 145 mg tablet blister pack | Mylan EPD | 233988 | CON-156 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| fenofibrate (FENOFIBRATE MYLAN) 48 mg tablet blister pack | Mylan EPD | 230444 | CON-156 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| fenofibrate (FENOFIBRATE MYLAN) 145 mg tablet blister pack | Mylan EPD | 230443 | CON-156 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| eprosartan/hydrochlorothiazide (TEVETEN PLUS 600/12.5) 600 mg/12.5 mg tablet blister pack | Mylan EPD | 143172 | CON-156 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| fenofibrate (LIPIDIL) 48 mg tablet blister pack | Mylan EPD | 118642 | CON-156 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| fenofibrate (LIPIDIL) 145 mg tablet blister pack | Mylan EPD | 118634 | CON-156 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| estradiol (as hemihydrate) (ZUMENON) 2 mg tablet blister pack | Mylan EPD | 75888 | CON-155 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| trandolapril (GOPTEN) 4 mg capsule blister pack | Mylan EPD | 96969 | CON-155 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| trandolapril (GOPTEN) 2 mg capsules blister pack | Mylan EPD | 45457 | CON-155 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| trandolapril (GOPTEN) 1 mg capsules blister pack | Mylan EPD | 45455 | CON-155 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| trandolapril (GOPTEN) 0.5 mg capsule blister pack | Mylan EPD | 45456 | CON-155 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| Terazosin (as hydrochloride dihydrate) (HYTRIN) 10 mg tablet blister pack | Mylan EPD | 121319 | CON-155 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| Terazosin (as hydrochloride dihydrate) (HYTRIN) 5 mg tablet blister pack | Mylan EPD | 121318 | CON-155 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| Terazosin (as hydrochloride dihydrate) (HYTRIN) 2 mg tablet blister pack | Mylan EPD | 121317 | CON-155 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| Terazosin (HYTRIN) 1 mg (as hydrochloride dihydrate) and Terazosin (HYTRIN) 2 mg (as hydrochloride dihydrate) tablet blister pack composite pack. | Mylan EPD | 121315 | CON-155 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| trandolapril/verapamil hydrochloride (TARKA 4/240) 4 mg/240 mg tablet blister pack | Mylan EPD | 104664 | CON-155 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| trandolapril/verapamil hydrochloride (TARKA 2/180) 2 mg/180 mg tablet blister pack | Mylan EPD | 104663 | CON-155 | The consent is effective from the 10 April 2017 until 10 October 2018. | 10/04/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines. | The product labels do not include the current address of the sponsor. | The labels to which this consent applies are those previously approved for the former address 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Supply | Prescription medicines | |
| pramipexole dihydrochloride monohydrate (PRAMIPEXOLE XR GP) 3 mg modified release tablet blister pack | Alphapharm Pty Ltd | 225631 | CON-158 | The consent is effective from 12 April 2017 until 12 April 2018 | 12/04/2017 | Paragraph 3(13)(a) of the Therapetuic Goods Order No. 69 General requirements for labels for medicines | On the blister foil labels of the products, the expiry date precedes the expiry date prefix ("Exp:"). | The blister foil label to be used for the products is the same as the sample blister foil label for the 3mg Pramipexole XR GP tablet submitted on 12 April 2017. For indicating the location of the expiry date, the foil label includes an arrow printed immediately to the left of the expiry date abbreviation "EXP:" while the location of the batch number is indicated by an arrow printed immediately to the right of the batch number abbreviation"Lot:" . During the 12 monthsexemption period, the company will take relevant corrective actions to enable the foil labels to be changed to ensure compliance with TGO No. 69. In this regard, in order to avoid confusion,the companyshould ensure that the batch number and expiry date prefixes printed on the carton and blister foil labels are the same. | Import and supply | Prescription medicines | |
| pramipexole dihydrochloride monohydrate (PRAMIPEXOLE XR GP) 4.5 mg modified release tablet blister pack | Alphapharm Pty Ltd | 225617 | CON-158 | The consent is effective from 12 April 2017 until 12 April 2018 | 12/04/2017 | Paragraph 3(13)(a) of the Therapetuic Goods Order No. 69 General requirements for labels for medicines | On the blister foil labels of the products, the expiry date precedes the expiry date prefix ("Exp:"). | The blister foil label to be used for the products is the same as the sample blister foil label for the 3mg Pramipexole XR GP tablet submitted on 12 April 2017. For indicating the location of the expiry date, the foil label includes an arrow printed immediately to the left of the expiry date abbreviation "EXP:" while the location of the batch number is indicated by an arrow printed immediately to the right of the batch number abbreviation"Lot:" . During the 12 monthsexemption period, the company will take relevant corrective actions to enable the foil labels to be changed to ensure compliance with TGO No. 69. In this regard, in order to avoid confusion,the companyshould ensure that the batch number and expiry date prefixes printed on the carton and blister foil labels are the same. | Import and supply | Prescription medicines | |
| pramipexole dihydrochloride monohydrate (PRAMIPEXOLE XR GP) 1.5 mg modified release tablet blister pack | Alphapharm Pty Ltd | 225600 | CON-158 | The consent is effective from 12 April 2017 until 12 April 2018 | 12/04/2017 | Paragraph 3(13)(a) of the Therapetuic Goods Order No. 69 General requirements for labels for medicines | On the blister foil labels of the products, the expiry date precedes the expiry date prefix ("Exp:"). | The blister foil label to be used for the products is the same as the sample blister foil label for the 3mg Pramipexole XR GP tablet submitted on 12 April 2017. For indicating the location of the expiry date, the foil label includes an arrow printed immediately to the left of the expiry date abbreviation "EXP:" while the location of the batch number is indicated by an arrow printed immediately to the right of the batch number abbreviation"Lot:" . During the 12 monthsexemption period, the company will take relevant corrective actions to enable the foil labels to be changed to ensure compliance with TGO No. 69. In this regard, in order to avoid confusion,the companyshould ensure that the batch number and expiry date prefixes printed on the carton and blister foil labels are the same. | Import and supply | Prescription medicines | |
| pramipexole dihydrochloride monohydrate (PRAMIPEXOLE XR GP) 3.75 mg modified release tablet blister pack | Alphapharm Pty Ltd | 225599 | CON-158 | The consent is effective from 12 April 2017 until 12 April 2018 | 12/04/2017 | Paragraph 3(13)(a) of the Therapetuic Goods Order No. 69 General requirements for labels for medicines | On the blister foil labels of the products, the expiry date precedes the expiry date prefix ("Exp:"). | The blister foil label to be used for the products is the same as the sample blister foil label for the 3mg Pramipexole XR GP tablet submitted on 12 April 2017. For indicating the location of the expiry date, the foil label includes an arrow printed immediately to the left of the expiry date abbreviation "EXP:" while the location of the batch number is indicated by an arrow printed immediately to the right of the batch number abbreviation"Lot:" . During the 12 monthsexemption period, the company will take relevant corrective actions to enable the foil labels to be changed to ensure compliance with TGO No. 69. In this regard, in order to avoid confusion,the companyshould ensure that the batch number and expiry date prefixes printed on the carton and blister foil labels are the same. | Import and supply | Prescription medicines | |
| pramipexole dihydrochloride monohydrate (PRAMIPEXOLE XR GP) 0.375 mg modified release tablet blister pack | Alphapharm Pty Ltd | 225591 | CON-158 | The consent is effective from 12 April 2017 until 12 April 2018 | 12/04/2017 | Paragraph 3(13)(a) of the Therapetuic Goods Order No. 69 General requirements for labels for medicines | On the blister foil labels of the products, the expiry date precedes the expiry date prefix ("Exp:"). | The blister foil label to be used for the products is the same as the sample blister foil label for the 3mg Pramipexole XR GP tablet submitted on 12 April 2017. For indicating the location of the expiry date, the foil label includes an arrow printed immediately to the left of the expiry date abbreviation "EXP:" while the location of the batch number is indicated by an arrow printed immediately to the right of the batch number abbreviation"Lot:" . During the 12 monthsexemption period, the company will take relevant corrective actions to enable the foil labels to be changed to ensure compliance with TGO No. 69. In this regard, in order to avoid confusion,the companyshould ensure that the batch number and expiry date prefixes printed on the carton and blister foil labels are the same. | Import and supply | Prescription medicines | |
| pramipexole dihydrochloride monohydrate (PRAMIPEXOLE XR GP) 2.25 mg modified release tablet blister pack | Alphapharm Pty Ltd | 225588 | CON-158 | The consent is effective from 12 April 2017 until 12 April 2018 | 12/04/2017 | Paragraph 3(13)(a) of the Therapetuic Goods Order No. 69 General requirements for labels for medicines | On the blister foil labels of the products, the expiry date precedes the expiry date prefix ("Exp:"). | The blister foil label to be used for the products is the same as the sample blister foil label for the 3mg Pramipexole XR GP tablet submitted on 12 April 2017. For indicating the location of the expiry date, the foil label includes an arrow printed immediately to the left of the expiry date abbreviation "EXP:" while the location of the batch number is indicated by an arrow printed immediately to the right of the batch number abbreviation"Lot:" . During the 12 monthsexemption period, the company will take relevant corrective actions to enable the foil labels to be changed to ensure compliance with TGO No. 69. In this regard, in order to avoid confusion,the companyshould ensure that the batch number and expiry date prefixes printed on the carton and blister foil labels are the same. | Import and supply | Prescription medicines | |
| pramipexole dihydrochloride monohydrate (PRAMIPEXOLE XR GP) 0.75 mg modified release tablet blister pack | Alphapharm Pty Ltd | 225585 | CON-158 | The consent is effective from 12 April 2017 until 12 April 2018 | 12/04/2017 | Paragraph 3(13)(a) of the Therapetuic Goods Order No. 69 General requirements for labels for medicines | On the blister foil labels of the products, the expiry date precedes the expiry date prefix ("Exp:"). | The blister foil label to be used for the products is the same as the sample blister foil label for the 3mg Pramipexole XR GP tablet submitted on 12 April 2017. For indicating the location of the expiry date, the foil label includes an arrow printed immediately to the left of the expiry date abbreviation "EXP:" while the location of the batch number is indicated by an arrow printed immediately to the right of the batch number abbreviation"Lot:" . During the 12 monthsexemption period, the company will take relevant corrective actions to enable the foil labels to be changed to ensure compliance with TGO No. 69. In this regard, in order to avoid confusion,the companyshould ensure that the batch number and expiry date prefixes printed on the carton and blister foil labels are the same. | Import and supply | Prescription medicines | |
| vandetanib (CAPRELSA) 100 mg film coated tablet blister pack | Sanofi-Aventis Australia Pty Ltd | 192496 | CON-159 | The consent is effective from 18 April 2017 until 31 January 2018. | 18/04/2017 | Paragraph 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels do not include the name and address details of the current sponsor. | The labels to which this consent applies are those previously approved for the former sponsor, AstraZeneca Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Sanofi-Aventis Australia Pty Ltd, the current sponsor. | Supply | Prescription medicines | |
| erythromycin (as ethylsuccinate) (EES) 200 mg/5 mL granules for oral liquid bottle | BNM Group | 173634 | CON-160 | The consent is effective from 19 April 2017 until 31 December 2018. | 19/04/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The product labels state the former Sponsor's name and contact details. | The labels to which this consent applies are those previously approved for the former sponsor Link Medical Products Pty Ltd (Link) and arrangements are in place with the former sponsor Link for the prompt referral of any queries or complaints concerning the products to Amdipharm Mercury Australia Pty Ltd (the current sponsor). | Supply | Prescription medicines | |
| azacitidine (CELAZADINE) 100 mg powder for injection vial | Celgene Pty Ltd | 216327 | CON-161 | The consent is effective from 21 April 2017 until 21 April 2019. | 21/04/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product label does not bear the current address of the sponsor. | The labels to which this consent applies are those previously approved with the old sponsor address and arrangements are in place with Australia Post to forward%23160;any mail concerning these products received at the old address (level 7/607 St Kilda Road, Melbourne VIC 3004) to the new address (Level 15/60 City Road Southbank VIC 3006). | Supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (PHARMACOR CANDESARTAN HCT 32/25) 32 mg/25 mg tablet blister pack | Generic Partners Pty Ltd | 204570 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (PHARMACOR CANDESARTAN HCT 32/12.5) 32 mg/12.5 mg tablet bottle | Generic Partners Pty Ltd | 196447 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (PHARMACOR CANDESARTAN HCT 16/12.5) 16 mg/12.5 mg tablet bottle | Generic Partners Pty Ltd | 196382 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (PHARMACOR CANDESARTAN HCT 32/12.5) 32 mg/12.5 mg tablet blister pack | Generic Partners Pty Ltd | 204569 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (PHARMACOR CANDESARTAN HCT 16/12.5) 16 mg/12.5 mg tablet blister pack | Generic Partners Pty Ltd | 204568 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (PHARMACOR CANDESARTAN HCT 32/25) 32 mg/25 mg tablet bottle | Generic Partners Pty Ltd | 196422 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CTAN HCTZ) 32 mg/25 mg tablet bottle | Generic Partners Pty Ltd | 253355 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CTAN HCTZ) 32 mg/12.5 mg tablet bottle | Generic Partners Pty Ltd | 262073 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CTAN HCTZ) 16 mg/12.5 mg tablet bottle | Generic Partners Pty Ltd | 253354 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CTAN HCTZ) 32 mg/25 mg tablet blister pack | Generic Partners Pty Ltd | 253353 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CTAN HCTZ) 32 mg/12.5 mg tablet blister pack | Generic Partners Pty Ltd | 253352 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CTAN HCTZ) 16 mg/12.5 mg tablet blister pack | Generic Partners Pty Ltd | 253332 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANSARTAN HCTZ) 32 mg/25 mg tablet bottle | Generic Partners Pty Ltd | 253377 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANSARTAN HCTZ) 32 mg/12.5 mg tablet bottle | Generic Partners Pty Ltd | 253376 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANSARTAN HCTZ) 32 mg/25 mg tablet blister pack | Generic Partners Pty Ltd | 253374 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANSARTAN HCTZ) 16 mg/12.5 mg tablet bottle | Generic Partners Pty Ltd | 253375 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANSARTAN HCTZ ) 32 mg/12.5 mg tablet blister pack | Generic Partners Pty Ltd | 253373 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANSARTAN HCTZ) 16 mg/12.5 mg tablet blister pack | Generic Partners Pty Ltd | 253372 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GXP) 32 mg/25 mg tablet bottle | Generic Partners Pty Ltd | 253593 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GXP) 32 mg/12.5 mg tablet bottle | Generic Partners Pty Ltd | 253592 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GXP) 16 mg/12.5 mg tablet bottle | Generic Partners Pty Ltd | 253573 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GXP) 32 mg/25 mg tablet blister pack | Generic Partners Pty Ltd | 253572 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GXP) 32 mg/12.5 mg tablet blister pack | Generic Partners Pty Ltd | 253552 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GXP) 16 mg/12.5 mg tablet blister pack | Generic Partners Pty Ltd | 253532 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GPPL) 32 mg/25 mg tablet bottle | Generic Partners Pty Ltd | 253513 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GPPL) 32 mg/12.5 mg tablet bottle | Generic Partners Pty Ltd | 253512 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GPPL) 16 mg/12.5 mg tablet bottle | Generic Partners Pty Ltd | 253495 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GPPL) 32 mg/25 mg tablet blister pack | Generic Partners Pty Ltd | 253494 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GPPL) 32 mg/12.5 mg tablet blister pack | Generic Partners Pty Ltd | 253493 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GPPL) 16 mg/12.5 mg tablet blister pack | Generic Partners Pty Ltd | 253492 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GENPAR) 32 mg/25 mg tablet bottle | Generic Partners Pty Ltd | 253632 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GENPAR) 32 mg/12.5 mg tablet bottle | Generic Partners Pty Ltd | 253616 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GENPAR) 16 mg/12.5 mg tablet bottle | Generic Partners Pty Ltd | 253615 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GENPAR ) 32 mg/25 mg tablet blister pack | Generic Partners Pty Ltd | 253614 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GENPAR) 32 mg/12.5 mg tablet blister pack | Generic Partners Pty Ltd | 253613 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GENPAR) 16 mg/12.5 mg tablet blister pack | Generic Partners Pty Ltd | 253612 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ ACTAVIS 32/25) 32 mg/25 mg tablet bottle | Generic Partners Pty Ltd | 196425 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ ACTAVIS 32/12.5) 32 mg/12.5 mg tablet bottle | Generic Partners Pty Ltd | 196388 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ ACTAVIS 16/12.5) 16 mg/12.5 mg tablet bottle | Generic Partners Pty Ltd | 196396 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ ACTAVIS 32/25) 32 mg/25 mg tablet blister pack | Generic Partners Pty Ltd | 204573 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ ACTAVIS 32/12.5) 32 mg/12.5 mg tablet blister pack | Generic Partners Pty Ltd | 204572 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ ACTAVIS 16/12.5) 16 mg/12.5 mg tablet blister pack | Generic Partners Pty Ltd | 204571 | CON-170 | The consent is effective from the 4 May 2017 until 5 May 2019 | 4/05/2017 | The products do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product) | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CTAN) 32 mg tablet bottle | Generic Partners Pty Ltd | 195446 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CTAN) 16 mg tablet bottle | Generic Partners Pty Ltd | 195494 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CTAN) 8 mg tablet bottle | Generic Partners Pty Ltd | 195476 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CTAN ) 4 mg tablet bottle | Generic Partners Pty Ltd | 195464 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CTAN) 32 mg tablet blister pack | Generic Partners Pty Ltd | 195477 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CTAN) 16 mg tablet blister pack | Generic Partners Pty Ltd | 195489 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CTAN) 8 mg tablet blister pack | Generic Partners Pty Ltd | 195475 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CTAN) 4 mg tablet blister pack | Generic Partners Pty Ltd | 195481 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (PHARMACOR CANDESARTAN 32) 32 mg tablet bottle | Generic Partners Pty Ltd | 195490 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (PHARMACOR CANDESARTAN 16) 16 mg tablet bottle | Generic Partners Pty Ltd | 195472 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (PHARMACOR CANDESARTAN 8) 8 mg tablet bottle | Generic Partners Pty Ltd | 195455 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (PHARMACOR CANDESARTAN 4) 4 mg tablet bottle | Generic Partners Pty Ltd | 195454 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (PHARMACOR CANDESARTAN 32) 32 mg tablet blister pack | Generic Partners Pty Ltd | 195469 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (PHARMACOR CANDESARTAN 16) 16 mg tablet blister pack | Generic Partners Pty Ltd | 195496 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (PHARMACOR CANDESARTAN 8) 8 mg tablet blister pack | Generic Partners Pty Ltd | 195500 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (PHARMACOR CANDESARTAN 4) 4 mg tablet blister pack | Generic Partners Pty Ltd | 195448 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CANDESARTAN GPPL) 32 mg tablet bottle | Generic Partners Pty Ltd | 195512 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CANDESARTAN GPPL) 16 mg tablet bottle | Generic Partners Pty Ltd | 195478 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CANDESARTAN GPPL) 8 mg tablet bottle | Generic Partners Pty Ltd | 195465 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CANDESARTAN GPPL) 4 mg tablet bottle | Generic Partners Pty Ltd | 195457 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CANDESARTAN GPPL) 32 mg tablet blister pack | Generic Partners Pty Ltd | 195462 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CANDESARTAN GPPL) 16 mg tablet blister pack | Generic Partners Pty Ltd | 195510 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CANDESARTAN GPPL) 8 mg tablet blister pack | Generic Partners Pty Ltd | 195499 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CANDESARTAN GPPL) 4 mg tablet blister pack | Generic Partners Pty Ltd | 195467 | CON-169 | The consent is effective from the 4 May 2017 until 5 May 2019. | 4/05/2017 | The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of not more than (NMT) 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| gliolan (aminolevulinic acid HCl) Powder for Oral Solution 30 mg/mL vial | Specialised Therapeutics Glio Pty Ltd | 202549 | CON-162 | The consent is effective from the 4 May 2017 until 4 May 2018. | 4/05/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The products do not state the name of the current sponsor. | The labels to which this consent applies are those previously approved for the former sponsor ‘Specialised Therapeutics Australia Pty Ltd’. Arrangements are in place with the former sponsor ‘Specialised Therapeutics Australia Pty Ltd’ for the prompt referral of any queries or complaints concerning the products to the current sponsor ‘Specialised Therapeutics Glio Pty Ltd’. | Import and supply | Prescription medicines | |
| lactulose (DUPHALAC) 667 mg/ mL oral liquid bottle | Mylan Health Pty Ltd | 13295 | CON-166 | The consent is effective from the5 May 2017 until 10 October 2018. | 5/05/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The product labels do not include the correct address of the sponsor | Supply | Over-the-counter medicines | ||
| ENLIVA | Mylan Health Pty Ltd | 232811 | CON-165 | The consent is effective from the 5 May 2017 until 10 October 2018. | 5/05/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The product labels do not include the correct address of the sponsor. | Supply | Listed complementary medicines | ||
| Ferrograd C tablet bottle | Mylan Health Pty Ltd | 66841 | CON-164 | The consent is effective from the 5 May 2017 until 10 October 2018. | 5/05/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The product labels do not include the correct address of the sponsor. | Supply | Registered complementary medicines | ||
| FGF tablet bottle | Mylan Health Pty Ltd | 77937 | CON-164 | The consent is effective from the 5 May 2017 until 10 October 2018. | 5/05/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The product labels do not include the correct address of the sponsor. | Supply | Registered complementary medicines | ||
| Ferro-grad iron tablet bottle | Mylan Health Pty Ltd | 59522 | CON-164 | The consent is effective from the 5 May 2017 until 10 October 2018. | 5/05/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The product labels do not include the correct address of the sponsor. | Supply | Registered complementary medicines | ||
| DONA Glucosamine | Meda Pharmaceuticals Pty Ltd | 161135 | CON-168 | The consent is effective from the 9 May 2017 until 9 May 2019. | 9/05/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicine. | The product labels do not include the correct address of the sponsor. | Import and supply | Listed complementary medicines | ||
| Dona Glucosamine Tablets | Meda Pharmaceuticals Pty Ltd | 119580 | CON-168 | The consent is effective from the 9 May 2017 until 9 May 2019. | 9/05/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicine. | The product labels do not include the correct address of the sponsor. | Import and supply | Listed complementary medicines | ||
| Elevit Breastfeeding | Bayer Australia Ltd | 282112 | CON-167 | The consent is effective from the 9 May 2017 until 9 May 2019. | 9/05/2017 | Parargraph 10 (b) of Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules. | The product does not comply with the upper limit of 120.0 per cent of the stated content for an active ingredient. | The content of the active ingredient, lutein, must not be less than 90.0 per cent and not more than 140.0 per cent of the stated content on the label. | Import and supply | Listed complementary medicines | |
| amoxicillin (as trihydrate) (CILAMOX) 500 mg capsule blister pack | Aspen Pharma Pty Ltd | 286258 | CON-163 | The consent is effective from the 9 May 2017 until 9 May 2019. | 9/05/2017 | Section 8(2) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines. | The carton labels do not include a minimum space of 70 x 30 millimetres for the dispensing label. | Import and supply | Prescription medicines | ||
| amoxicillin (as trihydrate) (CILAMOX) 250 mg capsule blister pack | Aspen Pharma Pty Ltd | 286257 | CON-163 | The consent is effective from the 9 May 2017 until 9 May 2019. | 9/05/2017 | Section 8(2) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines. | The carton labels do not include a minimum space of 70 x 30 millimetres for the dispensing label. | Import and supply | Prescription medicines | ||
| candesartan cilexetil/hydrochlorothiazide (CANDESAN COMBI 32/25) 32 mg/25 mg tablet blister pack | Arrow Pharma Pty Ltd | 204579 | CON-172 | The consent is effective from the 16 May 2017 until 15 May 2019. | 16/05/2017 | The products that do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product). | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESAN COMBI 32/12.5) 32 mg/12.5 mg tablet blister pack | Arrow Pharma Pty Ltd | 204578 | CON-172 | The consent is effective from the 16 May 2017 until 15 May 2019. | 16/05/2017 | The products that do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product). | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil/hydrochlorothiazide (CANDESAN COMBI 16/12.5) 16 mg/12.5 mg tablet blister pack | Arrow Pharma Pty Ltd | 204577 | CON-172 | The consent is effective from the 16 May 2017 until 15 May 2019. | 16/05/2017 | The products that do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product). | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CANDESAN) 8 mg tablet blister pack | Arrow Pharma Pty Ltd | 195509 | CON-171 | The consent is effective from the 16 May 2017 until 15 May 2019. | 16/05/2017 | Does not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CANDESAN) 4 mg tablet blister pack | Arrow Pharma Pty Ltd | 195483 | CON-171 | The consent is effective from the 16 May 2017 until 15 May 2019. | 16/05/2017 | Does not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CANDESAN) 32 mg tablet blister pack | Arrow Pharma Pty Ltd | 195459 | CON-171 | The consent is effective from the 16 May 2017 until 15 May 2019. | 16/05/2017 | Does not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| candesartan cilexetil (CANDESAN) 16 mg tablet blister pack | Arrow Pharma Pty Ltd | 195443 | CON-171 | The consent is effective from the 16 May 2017 until 15 May 2019. | 16/05/2017 | Does not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| Waxsol Ear Drops liquid bottle | MEDA Pharmaceuticals Pty Ltd | 18662 | CON-174 | The consent is effective from 22 May 2017 until 23 May 2019. | 22/05/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The products display the old address for the sponsor. | Import and supply | Registered complementary medicines | ||
| azelastine (as hydrochloride) (EYEZEP) 0.457 mg/mL eye drops bottle | MEDA Pharmaceuticals Pty Ltd | 97489 | CON-174 | The consent is effective from 22 May 2017 until 23 May 2019. | 22/05/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The products display the old address for the sponsor. | Import and supply | Registered complementary medicines | ||
| azelastine (as hydrochloride) (AZEP NASAL SPRAY) 125µg/actuation nasal spray aerosol, pump actuated-metered dose | MEDA Pharmaceuticals Pty Ltd | 104853 | CON-174 | The consent is effective from 22 May 2017 until 23 May 2019. | 22/05/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The products display the old address for the sponsor. | Import and supply | Registered complementary medicines | ||
| topotecan (as hydrochloride) (HYCAMTIN) 4 mg powder for injection vial | Novartis Pharmaceuticals Australia Pty Ltd | 58598 | CON-175 | The consent is effective from the 29 May 2017 until 29 November 2017 | 29/05/2017 | Paragraph 3(2)(l), 3(2)(n), 3(5)(b)(ii) and 3(14) of the Therapeutic Goods Order No.69 – General requirements for labels for medicines. | The products do not state the following The name and address of the current sponsor The registration number Use in one patient on one occasion only The directions for use are not stated in English on a leaflet inserted in the primary pack. | A 'Dear Healthcare Provider' letter identical to that provided to the Therapeutic Goods Administration on 24 May 2017 (TRIM reference D17-414385] will be supplied with each affected batch warning that there is a shortage of Australian registered Hycamtin (AUST R 58598) and that the Taiwanese Product Information is not in English and the Australian Product Information is included with each pack. | Import and supply | Prescription medicines | |
| acitretin (NEOTIGASON) 25 mg capsule blister pack | Teva Pharma Australia Pty Ltd | 52456 | CON-176 | The consent is effective from the 5 June 2017 until 5 June 2018. | 5/06/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | 1. The labels to which this consent applies are those previously approved for the former sponsor, Actavis Pty Limited and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Teva Pharma Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| acitretin (NEOTIGASON) 10 mg capsule blister pack | Teva Pharma Australia Pty Ltd | 52455 | CON-176 | The consent is effective from the 5 June 2017 until 5 June 2018. | 5/06/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels include the name and address of the previous sponsor of the products. | 1. The labels to which this consent applies are those previously approved for the former sponsor, Actavis Pty Limited and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Teva Pharma Australia Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| FEIBA-NF factor VIII inhibitor bypassing fraction 2500U powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 172236 | VNF2Q098AA -Exp 31-10-2017-Quantity 165 VNF2R036AA- Exp 31-03-2018-Quantity 232 VNF2R036AG -Exp 31-03-2018-Quantity 160 VNF2R069AC -Exp 31-07-2018-Quantity 168 | CON-177 | The consent is effective from the 7 June 2017 until 1July 2018. | 7/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. Baxalta is the sponsor of the above products but Baxter's details (name, address etc) and livery will appear on the labels from 1 July 2015. | 1. There will be minimal or no disruption to product supply. 2. Processes/measures have been implemented for the proposed duration of this consent to ensure there are no gaps in communication of medical information to patients and safety reporting. 3. The labels to which this consent applies are those previously approved for the former sponsor, Baxter Healthcare Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Baxalta Australia Pty Ltd. | Supply | Prescription medicines |
| protein c (CEPROTIN) 500 IU powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 104537 | VNC2Q008AK -Exp 31-07-2018 - Quantity 5 | CON-177 | The consent is effective from the 7 June 2017 until 1July 2018. | 7/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. Baxalta is the sponsor of the above products but Baxter's details (name, address etc) and livery will appear on the labels from 1 July 2015. | 1. There will be minimal or no disruption to product supply. 2. Processes/measures have been implemented for the proposed duration of this consent to ensure there are no gaps in communication of medical information to patients and safety reporting. 3. The labels to which this consent applies are those previously approved for the former sponsor, Baxter Healthcare Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Baxalta Australia Pty Ltd. | Supply | Prescription medicines |
| normal immunoglobulin (human) (KIOVIG) 20 g/200 mL solution for injection vial | Baxalta Australia Pty Ltd | 131973 | LE12Q379AJ-Exp 30-11-2018-Quantity 61 | CON-177 | The consent is effective from the 7 June 2017 until 1July 2018. | 7/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. Baxalta is the sponsor of the above products but Baxter's details (name, address etc) and livery will appear on the labels from 1 July 2015. | 1. There will be minimal or no disruption to product supply. 2. Processes/measures have been implemented for the proposed duration of this consent to ensure there are no gaps in communication of medical information to patients and safety reporting. 3. The labels to which this consent applies are those previously approved for the former sponsor, Baxter Healthcare Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Baxalta Australia Pty Ltd. | Supply | Prescription medicines |
| normal immunoglobulin (human) (KIOVIG) 2.5 g/25 mL solution for injection vial | Baxalta Australia Pty Ltd | 131966 | LE12Q355AE-Exp 31-10-2018 -Quantity 39 | CON-177 | The consent is effective from the 7 June 2017 until 1July 2018. | 7/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. Baxalta is the sponsor of the above products but Baxter's details (name, address etc) and livery will appear on the labels from 1 July 2015. | 1. There will be minimal or no disruption to product supply. 2. Processes/measures have been implemented for the proposed duration of this consent to ensure there are no gaps in communication of medical information to patients and safety reporting. 3. The labels to which this consent applies are those previously approved for the former sponsor, Baxter Healthcare Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Baxalta Australia Pty Ltd. | Supply | Prescription medicines |
| normal immunoglobulin (human) (KIOVIG) 10 g/100 mL solution for injection vial | Baxalta Australia Pty Ltd | 131969 | LE12Q340AG-Exp 31-10-2018-Quantity 58 LE12Q340AM-Exp 31-10-2018-Quantity 99 | CON-177 | The consent is effective from the 7 June 2017 until 1July 2018. | 7/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. Baxalta is the sponsor of the above products but Baxter's details (name, address etc) and livery will appear on the labels from 1 July 2015. | 1. There will be minimal or no disruption to product supply. 2. Processes/measures have been implemented for the proposed duration of this consent to ensure there are no gaps in communication of medical information to patients and safety reporting. 3. The labels to which this consent applies are those previously approved for the former sponsor, Baxter Healthcare Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Baxalta Australia Pty Ltd. | Supply | Prescription medicines |
| normal immunoglobulin (human) (KIOVIG) 1 g/10 mL solution for injection vial | Baxalta Australia Pty Ltd | 131953 | LE12Q344AC-Exp 31-10-2018-Quantity 69 LE12Q330AG-Exp 30-9-2018 - Quantity 36 | CON-177 | The consent is effective from the 7 June 2017 until 1July 2018. | 7/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. Baxalta is the sponsor of the above products but Baxter's details (name, address etc) and livery will appear on the labels from 1 July 2015. | 1. There will be minimal or no disruption to product supply. 2. Processes/measures have been implemented for the proposed duration of this consent to ensure there are no gaps in communication of medical information to patients and safety reporting. 3. The labels to which this consent applies are those previously approved for the former sponsor, Baxter Healthcare Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Baxalta Australia Pty Ltd. | Supply | Prescription medicines |
| octocog alfa (rch) (ADVATE) 2000 IU powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 136204 | LE17R029AC- Exp 30-6-2018- Quantity 52 LE17R029AD -Exp 30-6-2018- Quantity 73 | CON-177 | The consent is effective from the 7 June 2017 until 1July 2018. | 7/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. Baxalta is the sponsor of the above products but Baxter's details (name, address etc) and livery will appear on the labels from 1 July 2015. | 1. There will be minimal or no disruption to product supply. 2. Processes/measures have been implemented for the proposed duration of this consent to ensure there are no gaps in communication of medical information to patients and safety reporting. 3. The labels to which this consent applies are those previously approved for the former sponsor, Baxter Healthcare Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Baxalta Australia Pty Ltd. | Supply | Prescription medicines |
| octocog alfa (rch) (ADVATE) 1500 IU powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 100387 | LE01R532AD - Exp 30-6-2018 - Quantity 13 | CON-177 | The consent is effective from the 7 June 2017 until 1July 2018. | 7/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. Baxalta is the sponsor of the above products but Baxter's details (name, address etc) and livery will appear on the labels from 1 July 2015. | 1. There will be minimal or no disruption to product supply. 2. Processes/measures have been implemented for the proposed duration of this consent to ensure there are no gaps in communication of medical information to patients and safety reporting. 3. The labels to which this consent applies are those previously approved for the former sponsor, Baxter Healthcare Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Baxalta Australia Pty Ltd. | Supply | Prescription medicines |
| octocog alfa (rch) (ADVATE) 500 IU powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 100385 | LE01R026BE - Exp 30-6-2018 - Quantity 81 | CON-177 | The consent is effective from the 7 June 2017 until 1July 2018. | 7/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. Baxalta is the sponsor of the above products but Baxter's details (name, address etc) and livery will appear on the labels from 1 July 2015. | 1. There will be minimal or no disruption to product supply. 2. Processes/measures have been implemented for the proposed duration of this consent to ensure there are no gaps in communication of medical information to patients and safety reporting. 3. The labels to which this consent applies are those previously approved for the former sponsor, Baxter Healthcare Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Baxalta Australia Pty Ltd. | Supply | Prescription medicines |
| octocog alfa (rch) (ADVATE) 250 IU powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 100384 | LE01Q597AJ - Exp 30-11-2017 - Quantity 215 LE01R517AJ - Exp 28-2-2018 - Quantity 29 LE01R519AB - Exp 28-2-2018 - Quantity 14 LE01R550AB - Exp 31-7-2018 - Quantity 10 | CON-177 | The consent is effective from the 7 June 2017 until 1July 2018. | 7/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. Baxalta is the sponsor of the above products but Baxter's details (name, address etc) and livery will appear on the labels from 1 July 2015. | 1. There will be minimal or no disruption to product supply. 2. Processes/measures have been implemented for the proposed duration of this consent to ensure there are no gaps in communication of medical information to patients and safety reporting. 3. The labels to which this consent applies are those previously approved for the former sponsor, Baxter Healthcare Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Baxalta Australia Pty Ltd. | Supply | Prescription medicines |
| octocog alfa (rch) (ADVATE) 3000 IU powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 150366 | LE01Q595AJ - Exp 30-11-2017 - Quantity 13 LE01Q595AM -Exp 30-11-2017- Quantity 10 | CON-177 | The consent is effective from the 7 June 2017 until 1July 2018. | 7/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. Baxalta is the sponsor of the above products but Baxter's details (name, address etc) and livery will appear on the labels from 1 July 2015. | 1. There will be minimal or no disruption to product supply. 2. Processes/measures have been implemented for the proposed duration of this consent to ensure there are no gaps in communication of medical information to patients and safety reporting. 3. The labels to which this consent applies are those previously approved for the former sponsor, Baxter Healthcare Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Baxalta Australia Pty Ltd. | Supply | Prescription medicines |
| testosterone (ANDRODERM) 24.3 mg per day patch transdermal drug delivery system sachet | Teva Pharma Australia Pty Ltd | 82398 | Batch no. 1200952 | CON-179 | The consent is effective from 14 June 2017 until the batch is exhausted. | 14/06/2017 | Paragraph 3(2)(h), (i) (l) if the Therapuetic Goods Order No. 69 – General requirements for labels for medicines. | The individual product sachets do not have the batch number and expiry date prefixes on them and the labels state the previous sponsor's name. | 1.The batch and expiry details are easily distinguishable and the sachets are packed in cartons that comply with%23160;paragraph 3(2)(h) and (i) of TGO 69; 2. Arrangements are in place for the prompt referral of any queries or complaints concerning the products from Actavis [former sponsor] to Teva Pharma [the current sponsor]. | Import, supply and export | Prescription medicines |
| bisoprolol fumarate (BICOR ) 10 mg tablet blister pack | Alphapharm Pty Ltd | 81608 | CON-178 | The consent is effective from the 14 June 2017 until 14 June 2019. | 14/06/2017 | Parargraph 8 of the Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules. | The drug product release and expiry limits of the products do not comply with the individual monograph of the British Pharmacopoeia for Bisoprolol Fumarate Tablets, particularly for the assay, dissolution and related substance requirements. | 1. The drug product release and expiry limits for the products to which this consent applies are those currently approved (on 30 April 2007 under submission PM-2007-0479-3). | Import and supply | Prescription medicines | |
| bisoprolol Fumarate (BICOR) 7.5 mg tablet blister pack | Alphapharm Pty Ltd | 81607 | CON-178 | The consent is effective from the 14 June 2017 until 14 June 2019. | 14/06/2017 | Parargraph 8 of the Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules. | The drug product release and expiry limits of the products do not comply with the individual monograph of the British Pharmacopoeia for Bisoprolol Fumarate Tablets, particularly for the assay, dissolution and related substance requirements. | 1. The drug product release and expiry limits for the products to which this consent applies are those currently approved (on 30 April 2007 under submission PM-2007-0479-3). | Import and supply | Prescription medicines | |
| bisoprolol fumarate ( BICOR) 5 mg tablet blister pack | Alphapharm Pty Ltd | 81606 | CON-178 | The consent is effective from the 14 June 2017 until 14 June 2019. | 14/06/2017 | Parargraph 8 of the Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules. | The drug product release and expiry limits of the products do not comply with the individual monograph of the British Pharmacopoeia for Bisoprolol Fumarate Tablets, particularly for the assay, dissolution and related substance requirements. | 1. The drug product release and expiry limits for the products to which this consent applies are those currently approved (on 30 April 2007 under submission PM-2007-0479-3). | Import and supply | Prescription medicines | |
| bisoprolol fumarate (BICOR) 3.75 mg tablet blister pack | Alphapharm Pty Ltd | 81605 | CON-178 | The consent is effective from the 14 June 2017 until 14 June 2019. | 14/06/2017 | Parargraph 8 of the Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules. | The drug product release and expiry limits of the products do not comply with the individual monograph of the British Pharmacopoeia for Bisoprolol Fumarate Tablets, particularly for the assay, dissolution and related substance requirements. | 1. The drug product release and expiry limits for the products to which this consent applies are those currently approved (on 30 April 2007 under submission PM-2007-0479-3). | Import and supply | Prescription medicines | |
| bisoprolol fumarate (BICOR) 2.5 mg tablet blister pack | Alphapharm Pty Ltd | 81604 | CON-178 | The consent is effective from the 14 June 2017 until 14 June 2019. | 14/06/2017 | Parargraph 8 of the Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules. | The drug product release and expiry limits of the products do not comply with the individual monograph of the British Pharmacopoeia for Bisoprolol Fumarate Tablets, particularly for the assay, dissolution and related substance requirements. | 1. The drug product release and expiry limits for the products to which this consent applies are those currently approved (on 30 April 2007 under submission PM-2007-0479-3). | Import and supply | Prescription medicines | |
| bisoprolol fumarate (BICOR) 1.25 mg tablet blister pack | Alphapharm Pty Ltd | 81603 | CON-178 | The consent is effective from the 14 June 2017 until 14 June 2019. | 14/06/2017 | Parargraph 8 of the Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules. | The drug product release and expiry limits of the products do not comply with the individual monograph of the British Pharmacopoeia for Bisoprolol Fumarate Tablets, particularly for the assay, dissolution and related substance requirements. | 1. The drug product release and expiry limits for the products to which this consent applies are those currently approved (on 30 April 2007 under submission PM-2007-0479-3). | Import and supply | Prescription medicines | |
| bisoprolol fumarate (BISPRO) 10 mg tablet blister pack | Alphapharm Pty Ltd | 130182 | CON-178 | The consent is effective from the 14 June 2017 until 14 June 2019. | 14/06/2017 | Parargraph 8 of the Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules. | The drug product release and expiry limits of the products do not comply with the individual monograph of the British Pharmacopoeia for Bisoprolol Fumarate Tablets, particularly for the assay, dissolution and related substance requirements. | 1. The drug product release and expiry limits for the products to which this consent applies are those currently approved (on 30 April 2007 under submission PM-2007-0479-3). | Import and supply | Prescription medicines | |
| bisoprolol fumarate (BISPRO) 7.5 mg tablet blister pack | Alphapharm Pty Ltd | 130181 | CON-178 | The consent is effective from the 14 June 2017 until 14 June 2019. | 14/06/2017 | Parargraph 8 of the Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules. | The drug product release and expiry limits of the products do not comply with the individual monograph of the British Pharmacopoeia for Bisoprolol Fumarate Tablets, particularly for the assay, dissolution and related substance requirements. | 1. The drug product release and expiry limits for the products to which this consent applies are those currently approved (on 30 April 2007 under submission PM-2007-0479-3). | Import and supply | Prescription medicines | |
| bisoprolol fumarate (BISPRO) 5 mg tablet blister pack | Alphapharm Pty Ltd | 130180 | CON-178 | The consent is effective from the 14 June 2017 until 14 June 2019. | 14/06/2017 | Parargraph 8 of the Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules. | The drug product release and expiry limits of the products do not comply with the individual monograph of the British Pharmacopoeia for Bisoprolol Fumarate Tablets, particularly for the assay, dissolution and related substance requirements. | 1. The drug product release and expiry limits for the products to which this consent applies are those currently approved (on 30 April 2007 under submission PM-2007-0479-3). | Import and supply | Prescription medicines | |
| bisoprolol fumarate (BISPRO) 3.75 mg tablet blister pack | Alphapharm Pty Ltd | 130179 | CON-178 | The consent is effective from the 14 June 2017 until 14 June 2019. | 14/06/2017 | Parargraph 8 of the Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules. | The drug product release and expiry limits of the products do not comply with the individual monograph of the British Pharmacopoeia for Bisoprolol Fumarate Tablets, particularly for the assay, dissolution and related substance requirements. | 1. The drug product release and expiry limits for the products to which this consent applies are those currently approved (on 30 April 2007 under submission PM-2007-0479-3). | Import and supply | Prescription medicines | |
| bisoprolol fumarate (BISPRO) 2.5 mg tablet blister pack | Alphapharm Pty Ltd | 130178 | CON-178 | The consent is effective from the 14 June 2017 until 14 June 2019. | 14/06/2017 | Parargraph 8 of the Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules. | The drug product release and expiry limits of the products do not comply with the individual monograph of the British Pharmacopoeia for Bisoprolol Fumarate Tablets, particularly for the assay, dissolution and related substance requirements. | 1. The drug product release and expiry limits for the products to which this consent applies are those currently approved (on 30 April 2007 under submission PM-2007-0479-3). | Import and supply | Prescription medicines | |
| bisoprolol fumarate (BISPRO) 1.25 mg tablet blister pack | Alphapharm Pty Ltd | 130177 | CON-178 | The consent is effective from the 14 June 2017 until 14 June 2019. | 14/06/2017 | Parargraph 8 of the Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules. | The drug product release and expiry limits of the products do not comply with the individual monograph of the British Pharmacopoeia for Bisoprolol Fumarate Tablets, particularly for the assay, dissolution and related substance requirements. | 1. The drug product release and expiry limits for the products to which this consent applies are those currently approved (on 30 April 2007 under submission PM-2007-0479-3). | Import and supply | Prescription medicines | |
| estradiol (ZUMENON) (as hemihydrate) 2 mg tablet blister pack | Mylan Health Pty Ltd | 75888 | CON-180 | The consent is effective from the 15 June 2017 until 14 April 2019. | 15/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. | 1.The labels to which this consent applies are those previously approved for the former sponsor, BGP Products Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Mylan Health Pty Ltd. | Import and supply | Prescription medicines | |
| TARKA 4/240 trandolapril 4 mg verapamil hydrochloride 240 mg tablet blister pack | Mylan Health Pty Ltd | 104664 | CON-180 | The consent is effective from the 15 June 2017 until 14 April 2019. | 15/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. | 1.The labels to which this consent applies are those previously approved for the former sponsor, BGP Products Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Mylan Health Pty Ltd. | Import and supply | Prescription medicines | |
| TARKA 2/180 trandolapril 2 mg verapamil hydrochloride 180 mg tablet blister pack | Mylan Health Pty Ltd | 104663 | CON-180 | The consent is effective from the 15 June 2017 until 14 April 2019. | 15/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. | 1.The labels to which this consent applies are those previously approved for the former sponsor, BGP Products Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Mylan Health Pty Ltd. | Import and supply | Prescription medicines | |
| trandolapril (GOPTEN) 2 mg capsules blister pack | Mylan Health Pty Ltd | 45457 | CON-180 | The consent is effective from the 15 June 2017 until 14 April 2019. | 15/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. | 1.The labels to which this consent applies are those previously approved for the former sponsor, BGP Products Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Mylan Health Pty Ltd. | Import and supply | Prescription medicines | |
| trandolapril (GOPTEN) 0.5 mg capsule blister pack | Mylan Health Pty Ltd | 45456 | CON-180 | The consent is effective from the 15 June 2017 until 14 April 2019. | 15/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. | 1.The labels to which this consent applies are those previously approved for the former sponsor, BGP Products Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Mylan Health Pty Ltd. | Import and supply | Prescription medicines | |
| trandolapril (GOPTEN) 4 mg capsule blister pack | Mylan Health Pty Ltd | 96969 | CON-180 | The consent is effective from the 15 June 2017 until 14 April 2019. | 15/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. | 1.The labels to which this consent applies are those previously approved for the former sponsor, BGP Products Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Mylan Health Pty Ltd. | Import and supply | Prescription medicines | |
| trandolapril (GOPTEN) 1 mg capsules blister pack | Mylan Health Pty Ltd | 45455 | CON-180 | The consent is effective from the 15 June 2017 until 14 April 2019. | 15/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. | 1.The labels to which this consent applies are those previously approved for the former sponsor, BGP Products Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Mylan Health Pty Ltd. | Import and supply | Prescription medicines | |
| Terazosin (HYTRIN ) 5 mg (as hydrochloride dihydrate) tablet blister pack | Mylan Health Pty Ltd | 121318 | CON-180 | The consent is effective from the 15 June 2017 until 14 April 2019. | 15/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. | 1.The labels to which this consent applies are those previously approved for the former sponsor, BGP Products Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Mylan Health Pty Ltd. | Import and supply | Prescription medicines | |
| Terazosin (HYTRIN) 10 mg (as hydrochloride dihydrate) tablet blister pack | Mylan Health Pty Ltd | 121319 | CON-180 | The consent is effective from the 15 June 2017 until 14 April 2019. | 15/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. | 1.The labels to which this consent applies are those previously approved for the former sponsor, BGP Products Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Mylan Health Pty Ltd. | Import and supply | Prescription medicines | |
| Terazosin (HYTRIN) 2 mg (as hydrochloride dihydrate) tablet blister pack | Mylan Health Pty Ltd | 121317 | CON-180 | The consent is effective from the 15 June 2017 until 14 April 2019. | 15/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. | 1.The labels to which this consent applies are those previously approved for the former sponsor, BGP Products Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Mylan Health Pty Ltd. | Import and supply | Prescription medicines | |
| HYTRIN Terazosin 1mg (as hydrochloride dihydrate) and HYTRIN Terazosin 2mg (as hydrochloride dihydrate) tablet blister pack composite pack | Mylan Health Pty Ltd | 121315 | CON-180 | The consent is effective from the 15 June 2017 until 14 April 2019. | 15/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. | 1.The labels to which this consent applies are those previously approved for the former sponsor, BGP Products Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Mylan Health Pty Ltd. | Import and supply | Prescription medicines | |
| CREON MICRO pancreatic extract 20 g enteric coated granules bottle | Mylan Health Pty Ltd | 166118 | CON-180 | The consent is effective from the 15 June 2017 until 14 April 2019. | 15/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. | 1.The labels to which this consent applies are those previously approved for the former sponsor, BGP Products Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Mylan Health Pty Ltd. | Import and supply | Prescription medicines | |
| CREON 25,000 pancreatic extract 300 mg capsule bottle | Mylan Health Pty Ltd | 158452 | CON-180 | The consent is effective from the 15 June 2017 until 14 April 2019. | 15/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. | 1.The labels to which this consent applies are those previously approved for the former sponsor, BGP Products Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Mylan Health Pty Ltd. | Import and supply | Prescription medicines | |
| CREON 40,000 pancreatic extract 400 mg capsules of enteric-coated minimicropsheres bottle | Mylan Health Pty Ltd | 158451 | CON-180 | The consent is effective from the 15 June 2017 until 14 April 2019. | 15/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. | 1.The labels to which this consent applies are those previously approved for the former sponsor, BGP Products Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Mylan Health Pty Ltd. | Import and supply | Prescription medicines | |
| CREON 10,000 capsule bottle (reformulation) | Mylan Health Pty Ltd | 158453 | CON-180 | The consent is effective from the 15 June 2017 until 14 April 2019. | 15/06/2017 | Paragraph (3)(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products labels do not include the name and address of the current sponsor of the goods. | 1.The labels to which this consent applies are those previously approved for the former sponsor, BGP Products Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Mylan Health Pty Ltd. | Import and supply | Prescription medicines | |
| PINETARSOL GEL tar 16mg/g bottle | Ego Pharmaceuticals Pty Ltd | 49103 | CON-181 | The consent is effective from the 22 June 2017 until 30 June 2019. | 22/06/2017 | Section 8 of Therapeutic Goods Order No. 77 Microbiological Standards for Medicines | The product does not meet the preservative efficacy requirements for Aspergillus brasiliensis specified in the British Pharmacopoeia, Appendix XVI C. Efficacy of Antimicrobial Preservation or the European Pharmacopoeia, Efficacy of Antimicrobial Preservation (5.1.3). | The efficacy of antimicrobial preservation of the medicine against Aspergillus brasiliensis must meet the requirement specified in the United States Pharmacopoeia - National Formulary Chapter 51 Antimicrobial Effectiveness Testing. | Supply | Over-the-counter medicines | |
| PINETARSOL GEL tar 16mg/g tube | Ego Pharmaceuticals Pty Ltd | 49249 | CON-181 | The consent is effective from the 22 June 2017 until 30 June 2019. | 22/06/2017 | Section 8 of Therapeutic Goods Order No. 77 Microbiological Standards for Medicines | The product does not meet the preservative efficacy requirements for Aspergillus brasiliensis specified in the British Pharmacopoeia, Appendix XVI C. Efficacy of Antimicrobial Preservation or the European Pharmacopoeia, Efficacy of Antimicrobial Preservation (5.1.3). | The efficacy of antimicrobial preservation of the medicine against Aspergillus brasiliensis must meet the requirement specified in the United States Pharmacopoeia - National Formulary Chapter 51 Antimicrobial Effectiveness Testing. | Supply | Over-the-counter medicines | |
| ZADITEN ketotifen 250 microgram/mL eye drops ampoule | Novartis Pharmaceuticals Australia Pty Ltd | 113770 | CON-182 | The consent is effective from 23 June 2017 until 23 June 2019. | 23/06/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products display the name and contact details of the previous sponsor (Alcon Laboratories Australia Pty Ltd) instead of displaying name and contact details for the current sponsor (Novartis Pharmaceuticals Australia Pty Ltd). | Import and supply | Over-the-counter medicines | ||
| ZADITEN ketotifen 250 microgram/mL eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 99979 | CON-182 | The consent is effective from 23 June 2017 until 23 June 2019. | 23/06/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products display the name and contact details of the previous sponsor (Alcon Laboratories Australia Pty Ltd) instead of displaying name and contact details for the current sponsor (Novartis Pharmaceuticals Australia Pty Ltd). | Import and supply | Over-the-counter medicines | ||
| SYSTANE RED EYES naphazoline hydrochloride 1 mg/mL eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 286697 | CON-182 | The consent is effective from 23 June 2017 until 23 June 2019. | 23/06/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products display the name and contact details of the previous sponsor (Alcon Laboratories Australia Pty Ltd) instead of displaying name and contact details for the current sponsor (Novartis Pharmaceuticals Australia Pty Ltd). | Import and supply | Over-the-counter medicines | ||
| NAPHCON FORTE naphazoline hydrochloride 1 mg/mL eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 10231 | CON-182 | The consent is effective from 23 June 2017 until 23 June 2019. | 23/06/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products display the name and contact details of the previous sponsor (Alcon Laboratories Australia Pty Ltd) instead of displaying name and contact details for the current sponsor (Novartis Pharmaceuticals Australia Pty Ltd). | Import and supply | Over-the-counter medicines | ||
| NAPHCON A eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 47652 | CON-182 | The consent is effective from 23 June 2017 until 23 June 2019. | 23/06/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products display the name and contact details of the previous sponsor (Alcon Laboratories Australia Pty Ltd) instead of displaying name and contact details for the current sponsor (Novartis Pharmaceuticals Australia Pty Ltd). | Import and supply | Over-the-counter medicines | ||
| LOMIDE Lodoxamide 1.0 mg/mL (as trometamol) eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 54275 | CON-182 | The consent is effective from 23 June 2017 until 23 June 2019. | 23/06/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products display the name and contact details of the previous sponsor (Alcon Laboratories Australia Pty Ltd) instead of displaying name and contact details for the current sponsor (Novartis Pharmaceuticals Australia Pty Ltd). | Import and supply | Over-the-counter medicines | ||
| Eye Stream Solution for Irrigation Bottle | Novartis Pharmaceuticals Australia Pty Ltd | 19322 | CON-182 | The consent is effective from 23 June 2017 until 23 June 2019. | 23/06/2017 | Paragraph 3(2)(l) of the Therapeutic Goods Order No 69 – General requirements for labels for medicines. | The products display the name and contact details of the previous sponsor (Alcon Laboratories Australia Pty Ltd) instead of displaying name and contact details for the current sponsor (Novartis Pharmaceuticals Australia Pty Ltd). | Import and supply | Over-the-counter medicines | ||
| HEPATOLITE kit for production of Technetium(99mTc) disofenin powder for injection multidose vial | Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific | 19146 | 230054 | CON-183 | The consent is effective from the 28 June 2017 until batch 230054 is exhausted. | 28/06/2017 | Paragraph 7 of the Therapeutic Goods Order No. 69- General requirements for labels for medicines. | The storage condition is not described as permitted byparagraph 7 of TGO69. | 1. A 'Dear Healthcare Provider' letter identical to that provided to the Therapeutic Goods Administration with the application letter, stating the differences between the US and Australian-registered products, and that the Australian approved storage conditions should continue to be applied, is provided with each batch. 2. A copy of the Australian package insert will be supplied. 3. The carton labels are those used for the USA market and will be over-stickered with the Australian sponsor and AUST R number. | Import and supply | Prescription medicines |
| DUPHALAC Lactulose 667 mg/mL oral liquid bottle | Mylan Health Pty Ltd | 13295 | CON-185 | The consent is effective from the 14 July 2017 until 14 April 2019. | 14/07/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The label displays the name and address of the previous sponsor. | Arrangements are in place to forward the contacts made to the old sponsor address to the new sponsor. | Import and supply | Over-the-counter medicines | |
| METARAMINOL MONTROSE metaraminol (as tartrate) 10 mg/1 mL injection ampoule | Biotech Regulatory Solutions Pty Ltd | 99402 | 6M0081C29 6M0091C29 B6M0101C29 | CON-184 | The consent is effective from 14 July 2017 until 13 July 2018. | 14/07/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The carton and ampoule labels bear the former sponsor's name and address. | 1. The labels (carton and ampoule labels) to which this consent applies are those previously approved for the former sponsor Montrose Pharma Pty Ltd and arrangements are in place with the former sponsor Montrose Pharma Pty Ltd for the prompt referral of any complaints or safety related enquires concerning the products to the Global Harvest Pharmaceuticals Pty Ltd (current sponsor). | Import and supply | Prescription medicines |
| Elevit Film Coated Tablet | Bayer Australia Ltd | 291221 | CON-186 | Until further notice | 17/07/2017 | Sections 11(a), 11(b) and 11(c) of the Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules (TGO78) | Section 11(a) of the (TGO 78) requires that a registered tablet or capsule without an individual British Pharmacopoeia (BP) monograph must comply with the test for Uniformity of Dosage Units of the BP, in the general monographs ‘Tablets’ or ‘Capsules’, respectively. With respect to a registered tablet or capsule without an individual BP monograph, section 11(b), TGO 78 requires that the average content of each active ingredient in a pooled sample of not fewer than 20 tablets or capsules must be not less than 92.5% and not more than 107.5% of the stated content of that active ingredient. With respect to section 11(c), TGO 78 requires that a registered tablet or capsule without an individual BP monograph must comply with a suitable test for dissolution that demonstrates the appropriate release of each active ingredient for which the BP or United States Pharmacopeia-National Formulary (USP-NF) includes an individual monograph for a tablet or capsule and requires a test for dissolution. | 1. The goods are not required to comply with TGO 78 section 11(a) but must comply with the requirements of the British Pharmacopoeia Appendix XII C Uniformity of Weight (Mass).2. The goods are not required to comply with TGO 78 section 11(b) but the average content of each active ingredient in the goods must comply with the relevant acceptance criteria included in Attachment 2.3. The goods are not required to comply with TGO 78 section 11(c) but must comply with the dissolution requirements of the United States Pharmacopeia-National Formulary, Dietary Supplement Chapter 2040 ‘Disintegration and Dissolution of Dietary Supplements’ for riboflavine (Vitamin B2) and iron as set out in Attachment 2. | Supply | Over-the-counter medicines | |
| BLOOMS THE CHEMIST CANDESARTAN candesartan cilexetil 4 mg tablet blister pack | Apotex Pty Ltd | 260096 | CON-189 | The consent is effective from the 21 July 2017 until 21 July 2019. | 21/07/2017 | USP monograph for Candesartan Cilexetil Tablets (the default standard). | Theproductcandesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| BLOOMS THE CHEMIST CANDESARTAN candesartan cilexetil 8 mg tablet blister pack | Apotex Pty Ltd | 260095 | CON-189 | The consent is effective from the 21 July 2017 until 21 July 2019. | 21/07/2017 | USP monograph for Candesartan Cilexetil Tablets (the default standard). | Theproductcandesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| BLOOMS THE CHEMIST CANDESARTAN candesartan cilexetil 16 mg tablet blister pack | Apotex Pty Ltd | 260094 | CON-189 | The consent is effective from the 21 July 2017 until 21 July 2019. | 21/07/2017 | USP monograph for Candesartan Cilexetil Tablets (the default standard). | Theproductcandesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| BLOOMS THE CHEMIST CANDESARTAN candesartan cilexetil 32 mg tablet blister pack | Apotex Pty Ltd | 260093 | CON-189 | The consent is effective from the 21 July 2017 until 21 July 2019. | 21/07/2017 | USP monograph for Candesartan Cilexetil Tablets (the default standard). | Theproductcandesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CHEMMART CANDESARTAN candesartan cilexetil 8 mg tablet blister pack | Apotex Pty Ltd | 210563 | CON-189 | The consent is effective from the 21 July 2017 until 21 July 2019. | 21/07/2017 | USP monograph for Candesartan Cilexetil Tablets (the default standard). | Theproductcandesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CHEMMART CANDESARTAN candesartan cilexetil 32 mg tablet blister pack | Apotex Pty Ltd | 210549 | CON-189 | The consent is effective from the 21 July 2017 until 21 July 2019. | 21/07/2017 | USP monograph for Candesartan Cilexetil Tablets (the default standard). | Theproductcandesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CHEMMART CANDESARTAN candesartan cilexetil 16 mg tablet blister pack | Apotex Pty Ltd | 210548 | CON-189 | The consent is effective from the 21 July 2017 until 21 July 2019. | 21/07/2017 | USP monograph for Candesartan Cilexetil Tablets (the default standard). | Theproductcandesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CHEMMART CANDESARTAN candesartan cilexetil 4 mg tablet blister pack | Apotex Pty Ltd | 210547 | CON-189 | The consent is effective from the 21 July 2017 until 21 July 2019. | 21/07/2017 | USP monograph for Candesartan Cilexetil Tablets (the default standard). | Theproductcandesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| TERRY WHITE CHEMISTS CANDESARTAN candesartan cilexetil 32 mg tablet blister pack | Apotex Pty Ltd | 210536 | CON-189 | The consent is effective from the 21 July 2017 until 21 July 2019. | 21/07/2017 | USP monograph for Candesartan Cilexetil Tablets (the default standard). | Theproductcandesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| TERRY WHITE CHEMISTS CANDESARTAN candesartan cilexetil 16 mg tablet blister pack | Apotex Pty Ltd | 210535 | CON-189 | The consent is effective from the 21 July 2017 until 21 July 2019. | 21/07/2017 | USP monograph for Candesartan Cilexetil Tablets (the default standard). | Theproductcandesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| TERRY WHITE CHEMISTS CANDESARTAN candesartan cilexetil 8 mg tablet blister pack | Apotex Pty Ltd | 210534 | CON-189 | The consent is effective from the 21 July 2017 until 21 July 2019. | 21/07/2017 | USP monograph for Candesartan Cilexetil Tablets (the default standard). | Theproductcandesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| TERRY WHITE CHEMISTS CANDESARTAN candesartan cilexetil 4 mg tablet blister pack | Apotex Pty Ltd | 210533 | CON-189 | The consent is effective from the 21 July 2017 until 21 July 2019. | 21/07/2017 | USP monograph for Candesartan Cilexetil Tablets (the default standard). | Theproductcandesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| APO-CANDESARTAN candesartan cilexetil 32 mg tablet blister pack | Apotex Pty Ltd | 210532 | CON-189 | The consent is effective from the 21 July 2017 until 21 July 2019. | 21/07/2017 | USP monograph for Candesartan Cilexetil Tablets (the default standard). | Theproductcandesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| APO-CANDESARTAN candesartan cilexetil 16 mg tablet blister pack | Apotex Pty Ltd | 210531 | CON-189 | The consent is effective from the 21 July 2017 until 21 July 2019. | 21/07/2017 | USP monograph for Candesartan Cilexetil Tablets (the default standard). | Theproductcandesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| APO-CANDESARTAN candesartan cilexetil 8 mg tablet blister pack | Apotex Pty Ltd | 210530 | CON-189 | The consent is effective from the 21 July 2017 until 21 July 2019. | 21/07/2017 | USP monograph for Candesartan Cilexetil Tablets (the default standard). | Theproductcandesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| APO-CANDESARTAN candesartan cilexetil 4 mg tablet blister pack | Apotex Pty Ltd | 210529 | CON-189 | The consent is effective from the 21 July 2017 until 21 July 2019. | 21/07/2017 | USP monograph for Candesartan Cilexetil Tablets (the default standard). | Theproductcandesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| BLOOMS THE CHEMIST CANDESARTAN HCTZ 32/25 candesartan cilexetil 32 mg hydrochlorothiazide 25 mg tablet blister pack | Apotex Pty Ltd | 260000 | CON-188 | The consent is effective from 21 July 2017 until 21 July 2019 | 21/07/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| BLOOMS THE CHEMIST CANDESARTAN HCTZ 16/12.5 candesartan cilexetil 16 mg hydrochlorothiazide 12.5 mg tablet blister pack | Apotex Pty Ltd | 259999 | CON-188 | The consent is effective from 21 July 2017 until 21 July 2019 | 21/07/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| BLOOMS THE CHEMIST CANDESARTAN HCTZ 32/12.5 candesartan cilexetil 32 mg hydrochlorothiazide 12.5 mg tablet blister pack | Apotex Pty Ltd | 259998 | CON-188 | The consent is effective from 21 July 2017 until 21 July 2019 | 21/07/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| TERRY WHITE CHEMISTS CANDESARTAN HCTZ 32/25 candesartan cilexetil 32 mg hydrochlorothiazide 25 mg tablet blister pack | Apotex Pty Ltd | 210573 | CON-188 | The consent is effective from 21 July 2017 until 21 July 2019 | 21/07/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| TERRY WHITE CHEMISTS CANDESARTAN HCTZ 32/12.5 candesartan cilexetil 32 mg hydrochlorothiazide 12.5 mg tablet blister pack | Apotex Pty Ltd | 210572 | CON-188 | The consent is effective from 21 July 2017 until 21 July 2019 | 21/07/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| TERRY WHITE CHEMISTS CANDESARTAN HCTZ 16/12.5 candesartan cilexetil 16 mg hydrochlorothiazide 12.5 mg tablet blister pack | Apotex Pty Ltd | 210571 | CON-188 | The consent is effective from 21 July 2017 until 21 July 2019 | 21/07/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CHEMMART CANDESARTAN HCTZ 32/25 candesartan cilexetil 32 mg hydrochlorothiazide 25 mg tablet blister pack | Apotex Pty Ltd | 210570 | CON-188 | The consent is effective from 21 July 2017 until 21 July 2019 | 21/07/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CHEMMART CANDESARTAN HCTZ 32/12.5 candesartan cilexetil 32 mg hydrochlorothiazide 12.5 mg tablet blister pack | Apotex Pty Ltd | 210569 | CON-188 | The consent is effective from 21 July 2017 until 21 July 2019 | 21/07/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CHEMMART CANDESARTAN HCTZ 16/12.5 candesartan cilexetil 16 mg hydrochlorothiazide 12.5 mg tablet blister pack | Apotex Pty Ltd | 210568 | CON-188 | The consent is effective from 21 July 2017 until 21 July 2019 | 21/07/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| APO-CANDESARTAN HCTZ 32/25 candesartan cilexetil 32 mg hydrochlorothiazide 25 mg tablet blister pack | Apotex Pty Ltd | 210567 | CON-188 | The consent is effective from 21 July 2017 until 21 July 2019 | 21/07/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| APO- CANDESARTAN HCTZ 32/12.5 candesartan cilexetil 32 mg hydrochlorothiazide 12.5 mg tablet blister pack | Apotex Pty Ltd | 210566 | CON-188 | The consent is effective from 21 July 2017 until 21 July 2019 | 21/07/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| APO-CANDESARTAN HCTZ 16/12.5 candesartan cilexetil 16 mg hydrochlorothiazide 12.5 mg tablet blister pack | Apotex Pty Ltd | 210565 | CON-188 | The consent is effective from 21 July 2017 until 21 July 2019 | 21/07/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CSL FUNNEL WEB SPIDER ANTIVENOM (RABBIT) 125U powder for injection vial | Seqirus Pty Ltd | 31847 | 50410201 | CON-187 | The consent is effective from 21 July 2017 until the expiry date of the batch, on 30 March 2019 for batch 05041020. | 21/07/2017 | European Pharmacopoeia. | The product exceeds the test specification for water content. | 1. This consent applies only to CSL FUNNEL WEB SPIDER ANTIVENOM batch 050410201; 2. Non-compliance with the European Pharmacopoeia requirements is limited to the tests detailed in the application; 3. The shelf-life of the batch 050410201 will be reduced from 36 months to 24 months; and 4. A long term stability trial for batch 050410201 will be initiated to monitor the ongoing quality of the drug product. The Therapeutic Goods Administration should be notified in case of an adverse change in the quality of the product and appropriate actions should be taken to determine if recall of the product is necessary. | Supply | Prescription medicines |
| Bronchi-cough Pills (Qiguanyan Kesou Tanchuanwan) | Beijing Tong Ren Tang Australia Pty Ltd | 144659 | CON-196 | The consent is effective from 26 July 2017 until 6 January 2019. | 26/07/2017 | Clause 2 of TGO 69 or Section 6 of TGO 92. | The names ‘Cynomorium songaricum’ and ‘Baphicacanthus cusia’ used to describe the active ingredient on the label are not those which are accepted for inclusion in the Australian Approved Names List. | Import and supply | Listed complementary medicines | ||
| Jian Bu Qiang Shen Wan | Beijing Tong Ren Tang Australia Pty Ltd | 126978 | CON-196 | The consent is effective from 26 July 2017 until 6 January 2019. | 26/07/2017 | Clause 2 of TGO 69 or Section 6 of TGO 92. | The names ‘Cynomorium songaricum’ and ‘Baphicacanthus cusia’ used to describe the active ingredient on the label are not those which are accepted for inclusion in the Australian Approved Names List. | Import and supply | Listed complementary medicines | ||
| Zhuang Yang Yi Jing Wan a.k.a. Epimedium and Ginseng Formula | Sun Herbal Pty Ltd | 110583 | CON-195 | The consent is effective from the 26 July 2017 until 6 January 2019. | 26/07/2017 | Clause 2 of TGO 69 or Section 6 of TGO 92. | The name ‘Cynomorium songaricum’ used to describe the active ingredient on the label is not that which is accepted for inclusion in the Australian Approved Names List. | Import and supply | Listed complementary medicines | ||
| Nan Bao a.k.a. Men's Formula | Sun Herbal Pty Ltd | 148045 | CON-195 | The consent is effective from the 26 July 2017 until 6 January 2019. | 26/07/2017 | Clause 2 of TGO 69 or Section 6 of TGO 92. | The name ‘Cynomorium songaricum’ used to describe the active ingredient on the label is not that which is accepted for inclusion in the Australian Approved Names List. | Import and supply | Listed complementary medicines | ||
| G W Aust Age Reviver | G W Aust Pty Ltd | 201410 | CON-194 | The consent is effective from 26 July 2017 until 6 January 2019. | 26/07/2017 | Clause 2 of TGO 69 or Section 6 of TGO 92. | The name 'Cynomorium songaricum' used to describe the active ingredient on the label is not that which is accepted for inclusion in the Australian Approved Names List. | Import and supply | Listed complementary medicines | ||
| G W Aust MaxiBoost | G W Aust Pty Ltd | 168166 | CON-194 | The consent is effective from 26 July 2017 until 6 January 2019. | 26/07/2017 | Clause 2 of TGO 69 or Section 6 of TGO 92. | The name 'Cynomorium songaricum' used to describe the active ingredient on the label is not that which is accepted for inclusion in the Australian Approved Names List. | Import and supply | Listed complementary medicines | ||
| G W Aust MaxiBoost | G W Aust Pty Ltd | 232763 | CON-194 | The consent is effective from 26 July 2017 until 6 January 2019. | 26/07/2017 | Clause 2 of TGO 69 or Section 6 of TGO 92. | The name 'Cynomorium songaricum' used to describe the active ingredient on the label is not that which is accepted for inclusion in the Australian Approved Names List. | Import and supply | Listed complementary medicines | ||
| Pro Creation D | BlueSkyGreenEarth Herbs Pty Ltd | 100556 | CON-193 | The consent is effective from the 26 July 2017 until 6 January 2019. | 26/07/2017 | Clause 2 of TGO 69 or Section 6 of TGO 92. | The name ‘Cynomorium songaricum’ used to describe the active ingredient on the label is not that which is accepted for inclusion in the Australian Approved Names List. | Import and supply | Listed complementary medicines | ||
| %231 Body | BlueSkyGreenEarth Herbs Pty Ltd | 289148 | CON-193 | The consent is effective from the 26 July 2017 until 6 January 2019. | 26/07/2017 | Clause 2 of TGO 69 or Section 6 of TGO 92. | The name ‘Cynomorium songaricum’ used to describe the active ingredient on the label is not that which is accepted for inclusion in the Australian Approved Names List. | Import and supply | Listed complementary medicines | ||
| Shen Ye Jing | Wai Shun Pty Ltd | 131779 | CON-191 | The consent is effective from the 26 July 2017 until 6 January 2019. | 26/07/2017 | Clause 2 of TGO 69 or Section 6 of TGO 92. | The names ‘Cynomorium songaricum’ and ‘Baphicacanthus cusia’ used to describe the active ingredient on the label are not those which are accepted for inclusion in the Australian Approved Names List. | Import and supply | Listed complementary medicines | ||
| Shen Zhong Bu | Wai Shun Pty Ltd | 147282 | CON-191 | The consent is effective from the 26 July 2017 until 6 January 2019. | 26/07/2017 | Clause 2 of TGO 69 or Section 6 of TGO 92. | The names ‘Cynomorium songaricum’ and ‘Baphicacanthus cusia’ used to describe the active ingredient on the label are not those which are accepted for inclusion in the Australian Approved Names List. | Import and supply | Listed complementary medicines | ||
| SHEN NENG CONG RONG BU SHEN WAN | Shen Neng Herbal Medicines Group Pty Ltd | 150375 | CON-192 | The consent is effective from the 26 July 2017 until 6 January 2019. | 27/07/2017 | Clause 2 of TGO 69 or Section 6 of TGO 92. | The name 'Cynomorium songaricum' used to describe the active ingredient on the label is not that which is accepted for inclusion in the Australian Approved Names List. | Import and supply | Listed complementary medicines | ||
| ONDANSETRON SZ ODT ondansetron 8 mg orally disintegrating tablet blister pack | Dr Reddys Laboratories Australia Pty Ltd | 163654 | CON-219 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| ONDANSETRON SZ ODT ondansetron 4 mg orally disintegrating tablet blister pack | Dr Reddys Laboratories Australia Pty Ltd | 163653 | CON-219 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| PACLITAXEL EBEWE paclitaxel 300 mg/50 mL injection via | Sandoz Pty Ltd | 98551 | CON-218 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| VOXAM fluvoxamine maleate 100 mg tablet blister pack | Sandoz Pty Ltd | 111782 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| VOXAM fluvoxamine maleate 50 mg tablet blister pack | Sandoz Pty Ltd | 111781 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| VINORELBINE EBEWE 50 mg/5 mL (as tartrate) injection vial | Sandoz Pty Ltd | 99724 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| VINORELBINE EBEWE 10 mg/1 mL (as tartrate) injection vial | Sandoz Pty Ltd | 126693 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| VALACICLOVIR SANDOZ valaciclovir (as hydrochloride) 500 mg film-coated tablet blister pack | Sandoz Pty Ltd | 154464 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| TOPIRAMATE SANDOZ topiramate 50 mg tablet bottle | Sandoz Pty Ltd | 135779 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| TRAMADOL SANDOZ SR tramadol hydrochloride 200 mg modified release tablet blister pack | Sandoz Pty Ltd | 99258 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| TRAMADOL SANDOZ SR tramadol hydrochloride 150 mg modified release tablet blister pack | Sandoz Pty Ltd | 99252 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| TRAMADOL SANDOZ SR tramadol hydrochloride 100 mg modified release tablet blister pack | Sandoz Pty Ltd | 99239 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| TRAMADOL SANDOZ tramadol hydrochloride 100 mg/2 mL injection ampoule | Sandoz Pty Ltd | 102013 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| TEICOPLANIN SANDOZ teicoplanin 400 mg powder for injection vial with diluent ampoule | Sandoz Pty Ltd | 157812 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| TAMOXIFEN SANDOZ tamoxifen 20 mg (as citrate) tablet blister pack | Sandoz Pty Ltd | 80076 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| TACROLIMUS SANDOZ tacrolimus 5 mg capsule blister pack | Sandoz Pty Ltd | 153746 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| TACROLIMUS SANDOZ tacrolimus 1 mg capsule blister pack | Sandoz Pty Ltd | 153745 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| TACROLIMUS SANDOZ tacrolimus 0.5 mg capsule blister pack | Sandoz Pty Ltd | 153744 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| SERTRALINE SANDOZ sertraline hydrochloride 100 mg tablet blister pack | Sandoz Pty Ltd | 98698 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| SERTRALINE SANDOZ sertraline hydrochloride 50 mg tablet blister pack | Sandoz Pty Ltd | 98697 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| ROSUVASTATIN SANDOZ rosuvastatin (as calcium) 40 mg film-coated tablets blister pack | Sandoz Pty Ltd | 183599 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| ROSUVASTATIN SANDOZ rosuvastatin (as calcium) 20 mg film-coated tablets blister pack | Sandoz Pty Ltd | 183597 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| ROSUVASTATIN SANDOZ rosuvastatin (as calcium) 10 mg film-coated tablets blister pack | Sandoz Pty Ltd | 183595 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| ROSUVASTATIN SANDOZ rosuvastatin (as calcium) 5 mg film-coated tablets blister pack | Sandoz Pty Ltd | 183577 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| RILUZOLE SANDOZ riluzole 50 mg film-coated tablet blister pack | Sandoz Pty Ltd | 167717 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| RANITIDINE SANDOZ ranitidine 50 mg/5 mL (as hydrochloride) concentrated injection ampoules | Sandoz Pty Ltd | 75771 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| RAMIPRIL SANDOZ ramipril 10 mg tablet blister pack | Sandoz Pty Ltd | 127519 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| PROPOFOL SANDOZ propofol 1000 mg/100 mL emulsion for injection vial | Sandoz Pty Ltd | 148872 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| PROPOFOL SANDOZ propofol 500 mg/50 mL emulsion for injection vial | Sandoz Pty Ltd | 148871 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| PROPOFOL SANDOZ propofol 200 mg/20 mL emulsion for injection vial | Sandoz Pty Ltd | 148870 | CON-217 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| FLUOROURACIL EBEWE fluorouracil 5000 mg/100 mL solution for injection vial | Sandoz Pty Ltd | 166741 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| FLUDARABINE EBEWE fludarabine phosphate 50 mg / 2 mL concentrated injection vial | Sandoz Pty Ltd | 135540 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| FENTANYL SANDOZ fentanyl 100 micrograms/hour transdermal drug delivery system sachet | Sandoz Pty Ltd | 152576 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| FENTANYL SANDOZ fentanyl 12 micrograms/hour transdermal drug delivery system sachet | Sandoz Pty Ltd | 152572 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| FENTANYL SANDOZ fentanyl 50 micrograms/hour transdermal drug delivery system sachet | Sandoz Pty Ltd | 152571 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| FENTANYL SANDOZ fentanyl 25 micrograms/hour transdermal drug delivery system sachet | Sandoz Pty Ltd | 152569 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| FENTANYL SANDOZ fentanyl 75 micrograms/hour transdermal drug delivery system sachet | Sandoz Pty Ltd | 152568 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| EXEMESTANE SANDOZ exemestane 25 mg tablet blister pack | Sandoz Pty Ltd | 174337 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| ETOPOSIDE EBEWE etoposide 100 mg/5 mL injection vial | Sandoz Pty Ltd | 96641 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| EPIRUBICIN EBEWE epirubicin hydrochloride 100 mg/50 mL injection vial | Sandoz Pty Ltd | 131951 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| EPIRUBICIN EBEWE epirubicin hydrochloride 50 mg/25 mL injection vial | Sandoz Pty Ltd | 131950 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| EPIRUBICIN EBEWE epirubicin hydrochloride 10 mg/5 mL injection vial | Sandoz Pty Ltd | 131943 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| DOBUTAMINE SANDOZ dobutamine 250 mg/20 mL (as hydrochloride) injection ampoule | Sandoz Pty Ltd | 82994 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| DORZOLAMIDE/TIMOLOL SANDOZ 20/5 dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL eye drops solution bottle | Sandoz Pty Ltd | 211972 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| CURAM DUO FORTE 875/125 amoxicillin 875 mg (as trihydrate) and clavulanic acid 125 mg (as potassium) tablet strip pack | Sandoz Pty Ltd | 82829 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| CEFTAZIDIME SANDOZ ceftazidime 1 g (as pentahydrate) powder for injection vial | Sandoz Pty Ltd | 90915 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| CEFTRIAXONE SANDOZ ceftriaxone 1 g (as sodium) powder for injection via | Sandoz Pty Ltd | 75959 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| CEFALEXIN SANDOZ cefalexin monohydrate 250 mg capsules blister pack | Sandoz Pty Ltd | 150170 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| Capecitabine Sandoz capecitabine 500 mg film coated tablet blister pack | Sandoz Pty Ltd | 201800 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| BISOPROLOL SANDOZ bisoprolol fumarate 10 mg film-coated tablet blister pack | Sandoz Pty Ltd | 144888 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| BISOPROLOL SANDOZ bisoprolol fumarate 5 mg film-coated tablet blister pack | Sandoz Pty Ltd | 144884 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| BISOPROLOL SANDOZ bisoprolol fumarate 2.5 mg film-coated tablet blister pack | Sandoz Pty Ltd | 144867 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| ATORVASTATIN SZ atorvastatin (as calcium trihydrate) 10 mg tablets blister pack | Sandoz Pty Ltd | 179845 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| ATORVASTATIN SZ atorvastatin (as calcium trihydrate) 20 mg tablets blister pack | Sandoz Pty Ltd | 179842 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| ATORVASTATIN SZ atorvastatin (as calcium trihydrate) 80 mg tablets blister pack | Sandoz Pty Ltd | 179833 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| ATORVASTATIN SZ atorvastatin (as calcium trihydrate) 40 mg tablets blister pack | Sandoz Pty Ltd | 179823 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| ANASTROZOLE SANDOZ anastrozole 1 mg tablet blister pack | Sandoz Pty Ltd | 142746 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| AMOXYCILLIN SANDOZ amoxicillin trihydrate 125 mg/5 mL powder for oral suspension bottle | Sandoz Pty Ltd | 93721 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| AMOXYCILLIN SANDOZ amoxicillin 500 mg (as trihydrate) capsule blister pack | Sandoz Pty Ltd | 63333 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| ALENDRONATE SANDOZ alendronic acid 70 mg tablets blister pack | Sandoz Pty Ltd | 134981 | CON-216 | The consent is effective from the 31 July 2017 until the 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor’s former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| FLUCONAZOLE SANDOZ fluconazole 200 mg/100 mL injection vial | Sandoz Pty Ltd | 104302 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| PRAVASTATIN SANDOZ pravastatin sodium 10 mg tablet blister pack | Sandoz Pty Ltd | 152451 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| PRAVASTATIN SANDOZ pravastatin sodium 40 mg tablet blister pack | Sandoz Pty Ltd | 152450 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| PIOGLITAZONE SANDOZ pioglitazone (as hydrochloride) 45 mg tablet blister pack | Sandoz Pty Ltd | 162225 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| PIOGLITAZONE SANDOZ pioglitazone (as hydrochloride) 15 mg tablet blister pack | Sandoz Pty Ltd | 162223 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| PIOGLITAZONE SANDOZ pioglitazone (as hydrochloride) 30 mg tablet blister pack | Sandoz Pty Ltd | 162222 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| PAROXETINE SANDOZ paroxetine (as hydrochloride) 20 mg tablet blister pack | Sandoz Pty Ltd | 82551 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| PANTOPRAZOLE SANDOZ pantoprazole (as sodium) 40 mg powder for injection vial | Sandoz Pty Ltd | 147377 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| OXYTOCIN SANDOZ oxytocin 10 IU/1 mL injection ampoule | Sandoz Pty Ltd | 162499 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| OXYTOCIN SANDOZ oxytocin 5 IU/1 mL injection ampoule | Sandoz Pty Ltd | 162498 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| OMNITROPE somatropin (rbe) 10 mg/1.5 mL solution for injection cartridge with pre-assembled cartridge holder | Sandoz Pty Ltd | 224623 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| OMNITROPE somatropin (rbe) 10 mg/1.5 mL solution for injection cartridge | Sandoz Pty Ltd | 162522 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| OMNITROPE somatropin (rbe) 5 mg/1.5 mL injection cartridge with pre-assembled cartridge holder | Sandoz Pty Ltd | 224622 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| OMNITROPE somatropin (rbe) 15 mg/1.5 mL solution for injection cartridge | Sandoz Pty Ltd | 205625 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| MITOZANTRONE EBEWE mitozantrone (as hydrochloride) 20 mg/10 mL solution for injection vial | Sandoz Pty Ltd | 132327 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| MIRTAZAPINE SANDOZ mirtazapine 45 mg tablets blister pack | Sandoz Pty Ltd | 117157 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| MIRTAZAPINE SANDOZ mirtazapine 30 mg tablets blister pack | Sandoz Pty Ltd | 117156 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| MIRTAZAPINE SANDOZ ODT 45 mirtazapine 45 mg orally disintegrating tablets blister pack | Sandoz Pty Ltd | 183403 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| MIRTAZAPINE SANDOZ ODT 30 mirtazapine 30 mg orally disintegrating tablets blister pack | Sandoz Pty Ltd | 183402 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| MIRTAZAPINE SANDOZ ODT 15 mirtazapine 15 mg orally disintegrating tablets blister pack | Sandoz Pty Ltd | 183401 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| METHOTREXATE EBEWE methotrexate 5000 mg/50 mL concentrated injection vial | Sandoz Pty Ltd | 120618 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| METFORMIN SANDOZ metformin hydrochloride 1000 mg tablets bottle | Sandoz Pty Ltd | 123673 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| METFORMIN SANDOZ metformin hydrochloride 500 mg tablet bottle | Sandoz Pty Ltd | 148268 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| METFORMIN SANDOZ metformin hydrochloride 500 mg tablet blister pack | Sandoz Pty Ltd | 125661 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| METFORMIN SANDOZ metformin hydrochloride 850 mg tablet blister pack | Sandoz Pty Ltd | 125662 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| METFORMIN SANDOZ metformin hydrochloride 1000 mg tablets blister pack | Sandoz Pty Ltd | 123665 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| MELOXICAM SZ meloxicam 15 mg tablet blister pack | Sandoz Pty Ltd | 127718 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| MELOXICAM SANDOZ meloxicam 7.5 mg capsule blister pack | Sandoz Pty Ltd | 199661 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| LISINOPRIL SANDOZ lisinopril dihydrate 20 mg tablet blister pack | Sandoz Pty Ltd | 158108 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| LISINOPRIL SANDOZ lisinopril dihydrate 10 mg tablet blister pack | Sandoz Pty Ltd | 158101 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| LISINOPRIL SANDOZ lisinopril dihydrate 5 mg tablet blister pack | Sandoz Pty Ltd | 158100 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| LEVETIRACETAM SANDOZ levetiracetam 500 mg /5 mL concentrate solution for IV infusion vial | Sandoz Pty Ltd | 193204 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| LETROZOLE SANDOZ letrozole 2.5 mg tablet blister pack | Sandoz Pty Ltd | 172124 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| Latanoprost/Timolol Sandoz 50/5 latanoprost 50 microgram/mL timolol 5 mg/mL Eye Drops | Sandoz Pty Ltd | 204403 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| LATANOPROST SANDOZ latanoprost 50 micrograms/mL eye drop solution bottle | Sandoz Pty Ltd | 171691 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| IRBESARTAN SANDOZ irbesartan 150 mg film-coated tablet blister pack | Sandoz Pty Ltd | 167409 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| IRBESARTAN SANDOZ irbesartan 300 mg film-coated tablet blister pack | Sandoz Pty Ltd | 167407 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| IRBESARTAN SANDOZ irbesartan 75 mg film-coated tablet blister pack | Sandoz Pty Ltd | 167406 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| INDAPAMIDE SANDOZ indapamide hemihydrate 2.5 mg tablet blister pack | Sandoz Pty Ltd | 169291 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| IDARUBICIN EBEWE idarubicin hydrochloride 5 mg/5 mL concentrated injection vial | Sandoz Pty Ltd | 162933 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| IDARUBICIN EBEWE idarubicin hydrochloride 10 mg/10 mL concentrated injection vial | Sandoz Pty Ltd | 162931 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| GABAPENTIN SANDOZ gabapentin 300 mg capsule blister pack | Sandoz Pty Ltd | 157197 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| GABAPENTIN SANDOZ gabapentin 400 mg capsule blister pack | Sandoz Pty Ltd | 157195 | CON-215 | The consent is effective from the 31 July 2017 until 31 July 2018. | 31/07/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The labels of the products do not contain the current company address. | The labels to which this consent applies are those previously approved that contained the sponsor's former address at 19 Harris Street Pyrmont NSW 2009 and arrangements are in place to re-direct correspondence to the current sponsor address. | Import and supply | Prescription medicines | |
| ZINFORO ceftaroline fosamil 600 mg powder for injection vial | Pfizer Australia Pty Ltd | 192260 | CON-197 | The consent is effective from the 4 August 2017 until 1 August 2018. | 4/08/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69. | The product labelling does not bear the current sponsor’s name and address. | 1. The labels (carton and vial labels) to which this consent applies are those approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in place with the former sponsor (AstraZeneca Pty Ltd) that any correspondence concerning this product will be redirected to the current sponsor, Pfizer Australia Pty Ltd.2. A ‘Dear Healthcare Professional’ letter, as assured inthe letter of application, will be sent to relevant stakeholders explaining the sponsorship change and new contact for this product. | Import and supply | Prescription medicines | |
| CANDESARTAN HCT GH 32/25 candesartan cilexetil 32 mg hydrochlorothiazide 25 mg tablet bottle | Generic Health Pty Ltd | 196437 | CON-199 | The consent is effective from the 9 August 2017 until 8 August 2019. | 9/08/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CANDESARTAN HCT GH 32/12.5 candesartan cilexetil 32 mg hydrochlorothiazide 12.5 mg tablet bottle | Generic Health Pty Ltd | 196415 | CON-199 | The consent is effective from the 9 August 2017 until 8 August 2019. | 9/08/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CANDESARTAN HCT GH 16/12.5 candesartan cilexetil 16 mg hydrochlorothiazide 12.5 mg tablet bottle | Generic Health Pty Ltd | 196385 | CON-199 | The consent is effective from the 9 August 2017 until 8 August 2019. | 9/08/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CANDESARTAN HCT GH 32/25 candesartan cilexetil 32 mg hydrochlorothiazide 25 mg tablet blister pack | Generic Health Pty Ltd | 204582 | CON-199 | The consent is effective from the 9 August 2017 until 8 August 2019. | 9/08/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CANDESARTAN HCT GH 32/12.5 candesartan cilexetil 32 mg hydrochlorothiazide 12.5 mg tablet blister pack | Generic Health Pty Ltd | 204581 | CON-199 | The consent is effective from the 9 August 2017 until 8 August 2019. | 9/08/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CANDESARTAN HCT GH 16/12.5 candesartan cilexetil 16 mg hydrochlorothiazide 12.5 mg tablet blister pack | Generic Health Pty Ltd | 204580 | CON-199 | The consent is effective from the 9 August 2017 until 8 August 2019. | 9/08/2017 | USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CANDESARTAN GH candesartan cilexetil 32 mg tablet bottle | Generic Health Pty Ltd | 195488 | CON-198 | The consent is effective from the 9 August 2017 until 8 August 2019. | 9/08/2017 | USP monograph for Candesartan Cilexetil. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CANDESARTAN GH candesartan cilexetil 16 mg tablet bottle | Generic Health Pty Ltd | 195508 | CON-198 | The consent is effective from the 9 August 2017 until 8 August 2019. | 9/08/2017 | USP monograph for Candesartan Cilexetil. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CANDESARTAN GH candesartan cilexetil 8 mg tablet bottle | Generic Health Pty Ltd | 195474 | CON-198 | The consent is effective from the 9 August 2017 until 8 August 2019. | 9/08/2017 | USP monograph for Candesartan Cilexetil. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CANDESARTAN GH candesartan cilexetil 4 mg tablet bottle | Generic Health Pty Ltd | 195504 | CON-198 | The consent is effective from the 9 August 2017 until 8 August 2019. | 9/08/2017 | USP monograph for Candesartan Cilexetil. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CANDESARTAN GH candesartan cilexetil 32 mg tablet blister pack | Generic Health Pty Ltd | 195479 | CON-198 | The consent is effective from the 9 August 2017 until 8 August 2019. | 9/08/2017 | USP monograph for Candesartan Cilexetil. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CANDESARTAN GH candesartan cilexetil 16 mg tablet blister pack | Generic Health Pty Ltd | 195485 | CON-198 | The consent is effective from the 9 August 2017 until 8 August 2019. | 9/08/2017 | USP monograph for Candesartan Cilexetil. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CANDESARTAN GH candesartan cilexetil 8 mg tablet blister pack | Generic Health Pty Ltd | 195503 | CON-198 | The consent is effective from the 9 August 2017 until 8 August 2019. | 9/08/2017 | USP monograph for Candesartan Cilexetil. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| CANDESARTAN GH candesartan cilexetil 4 mg tablet blister pack | Generic Health Pty Ltd | 195447 | CON-198 | The consent is effective from the 9 August 2017 until 8 August 2019. | 9/08/2017 | USP monograph for Candesartan Cilexetil. | The candesartan impurity E content exceeds the USP monograph requirement of NMT 0.2%. | The candesartan impurity E expiry limit in drug product is the same as that currently approved (NMT 0.5%). | Import and supply | Prescription medicines | |
| Australian Red Cross Blood Service | N/A | CON-398 | The consentis effective from the 11th August 2017 until the following conditions no longer remain true. | 11/08/2017 | Section 11 subparagraph 3(a)(I) Table 3 in the Therapeutic Goods Order No. 88 - Standards for donor selection, testing, and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products | In that the products aremanufactured from donations obtained where only new donors or donors of leucocytecomponents are tested for antibodies to human T-cell lymphotrophic virus (HTLV). | 1.All donors must have a documented HTLV negative test,2. All new donors must be tested,3. Repeat donors who are donating leucocyte components must be tested,4. The prevalence of HTLV in Australia stays the same (no increase in HTLVincidence rate in repeat donors), and5. Leucodepletion retains high effectiveness and continues to be applied to all redcell and platelet components, as well as plasma collected by apheresis. | Supply | Blood, tissues, and biologicals | ||
| FERROGRAD C tablet bottle | Mylan Health Pty Ltd | 66841 | CON-201 | The consent is effective from the 14 August 2017 until 14 April 2019. | 14/08/2017 | Subclause 3(2)(l) of TGO 69. | The product labels do not include the correct name and address of the sponsor. | Import and supply | Registered complementary medicines | ||
| Ferro-grad F iron folic acid FGF tablet bottle | Mylan Health Pty Ltd | 77937 | CON-201 | The consent is effective from the 14 August 2017 until 14 April 2019. | 14/08/2017 | Subclause 3(2)(l) of TGO 69. | The product labels do not include the correct name and address of the sponsor. | Import and supply | Registered complementary medicines | ||
| Ferro-grad iron tablet bottle | Mylan Health Pty Ltd | 59522 | CON-201 | The consent is effective from the 14 August 2017 until 14 April 2019. | 14/08/2017 | Subclause 3(2)(l) of TGO 69. | The product labels do not include the correct name and address of the sponsor. | Import and supply | Registered complementary medicines | ||
| ENLIVA | Mylan Health Pty Ltd | 232811 | CON-200 | The consent is effective from the 14 August 2017 until 14 April 2019. | 14/08/2017 | Subclause 3(2)(l) of TGO 69 | The product labels do not include the correct name and address of the sponsor. | Import and supply | Listed complementary medicines | ||
| BOSENTAN SANDOZ bosentan (as monohydrate) 125 mg film coated tablet blister pack | Sandoz Pty Ltd | 242053 | 17B231, with expiry date 02/2020, 362 units 17B232, with expiry date 02/2020, 390 units. | CON-203 | The consent is effective from the 16 August 2017 until the batches have been supplied. | 16/08/2017 | Subclauses 3(2)(h) and (i) of Therapeutic Goods Order No. 69. | The foil labels lack the appropriate prefix for batch number and expiry date. | 1.A Dear Healthcare provider letter identical to that provided to the TherapeuticGoodsAdministrationon 15 August 2017, advising them to remind patients to keep the blister packs with the correctly labelled carton, must be provided with each of the affected batches; 2.The carton and foil labels to which this consent applies are those provided with the application. | Supply | Prescription medicines |
| BOSENTAN SANDOZ bosentan (as monohydrate) 62.5 mg film coated tablet blister pack | Sandoz Pty Ltd | 242052 | 17B233, with expiry date 02/2020, 215 units | CON-203 | The consent is effective from the 16 August 2017 until the batches have been supplied. | 16/08/2017 | Subclauses 3(2)(h) and (i) of Therapeutic Goods Order No. 69. | The foil labels lack the appropriate prefix for batch number and expiry date. | 1.A Dear Healthcare provider letter identical to that provided to the TherapeuticGoodsAdministrationon 15 August 2017, advising them to remind patients to keep the blister packs with the correctly labelled carton, must be provided with each of the affected batches; 2.The carton and foil labels to which this consent applies are those provided with the application. | Supply | Prescription medicines |
| PARACETAMOL KABI paracetamol 500 mg/50 mL solution for injection vial | Fresenius Kabi Australia Pty Ltd | 203625 | 16KE4439 | CON-202 | The consent is effective from the 16 August 2017 to: 31 October 2017 (for ARTG 29771) 31 August 2017 (for ARTG 29790) 31 December 2017 (for ARTG 29599) 30 November 2017 (for ARTG 198332) 31 January 2018 (for ARTG 197200) 31 August 2018 (for ARTG 211732) 31 August 2018 (for ARTG 213304) 31 January 2018 (for ARTG 191018) 30 November 2018 (for ARTG 188775) 31 August 2017 (for ARTG 203625) | 16/08/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69. | The products do not have the current sponsor address printed on the labels. | The labels to which this consent applies are those previously approved where the product labels bear the former sponsor address and that arrangements are in place to redirect all mail to the new sponsor address. | Supply | Prescription medicines |
| Ondansetron Kabi ondansetron hydrochloride dihydrate 8 mg/4 mL Solution for Injection glass ampoule | Fresenius Kabi Australia Pty Ltd | 188775 | 18M012404 | CON-202 | The consent is effective from the 16 August 2017 to: 31 October 2017 (for ARTG 29771) 31 August 2017 (for ARTG 29790) 31 December 2017 (for ARTG 29599) 30 November 2017 (for ARTG 198332) 31 January 2018 (for ARTG 197200) 31 August 2018 (for ARTG 211732) 31 August 2018 (for ARTG 213304) 31 January 2018 (for ARTG 191018) 30 November 2018 (for ARTG 188775) 31 August 2017 (for ARTG 203625) | 16/08/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69. | The products do not have the current sponsor address printed on the labels. | The labels to which this consent applies are those previously approved where the product labels bear the former sponsor address and that arrangements are in place to redirect all mail to the new sponsor address. | Supply | Prescription medicines |
| Ondansetron Kabi ondansetron hydrochloride dihydrate 4 mg/2 mL Solution for Injection glass ampoule | Fresenius Kabi Australia Pty Ltd | 191018 | 18H002503 | CON-202 | The consent is effective from the 16 August 2017 to: 31 October 2017 (for ARTG 29771) 31 August 2017 (for ARTG 29790) 31 December 2017 (for ARTG 29599) 30 November 2017 (for ARTG 198332) 31 January 2018 (for ARTG 197200) 31 August 2018 (for ARTG 211732) 31 August 2018 (for ARTG 213304) 31 January 2018 (for ARTG 191018) 30 November 2018 (for ARTG 188775) 31 August 2017 (for ARTG 203625) | 16/08/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69. | The products do not have the current sponsor address printed on the labels. | The labels to which this consent applies are those previously approved where the product labels bear the former sponsor address and that arrangements are in place to redirect all mail to the new sponsor address. | Supply | Prescription medicines |
| Ionolyte sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride, Injection for intravenous infusion 1000 mL Freeflex bag | Fresenius Kabi Australia Pty Ltd | 213304 | 13IIL214 | CON-202 | The consent is effective from the 16 August 2017 to: 31 October 2017 (for ARTG 29771) 31 August 2017 (for ARTG 29790) 31 December 2017 (for ARTG 29599) 30 November 2017 (for ARTG 198332) 31 January 2018 (for ARTG 197200) 31 August 2018 (for ARTG 211732) 31 August 2018 (for ARTG 213304) 31 January 2018 (for ARTG 191018) 30 November 2018 (for ARTG 188775) 31 August 2017 (for ARTG 203625) | 16/08/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69. | The products do not have the current sponsor address printed on the labels. | The labels to which this consent applies are those previously approved where the product labels bear the former sponsor address and that arrangements are in place to redirect all mail to the new sponsor address. | Supply | Prescription medicines |
| Ionolyte sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride, Injection for intravenous infusion 500 mL Freeflex bag | Fresenius Kabi Australia Pty Ltd | 211732 | 13IIL215 | CON-202 | The consent is effective from the 16 August 2017 to: 31 October 2017 (for ARTG 29771) 31 August 2017 (for ARTG 29790) 31 December 2017 (for ARTG 29599) 30 November 2017 (for ARTG 198332) 31 January 2018 (for ARTG 197200) 31 August 2018 (for ARTG 211732) 31 August 2018 (for ARTG 213304) 31 January 2018 (for ARTG 191018) 30 November 2018 (for ARTG 188775) 31 August 2017 (for ARTG 203625) | 16/08/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69. | The products do not have the current sponsor address printed on the labels. | The labels to which this consent applies are those previously approved where the product labels bear the former sponsor address and that arrangements are in place to redirect all mail to the new sponsor address. | Supply | Prescription medicines |
| SODIUM CHLORIDE INJECTION BP 0.9%, sodium chloride, 5 mL ampoule | Fresenius Kabi Australia Pty Ltd | 197200 | 20ILB007 | CON-202 | The consent is effective from the 16 August 2017 to: 31 October 2017 (for ARTG 29771) 31 August 2017 (for ARTG 29790) 31 December 2017 (for ARTG 29599) 30 November 2017 (for ARTG 198332) 31 January 2018 (for ARTG 197200) 31 August 2018 (for ARTG 211732) 31 August 2018 (for ARTG 213304) 31 January 2018 (for ARTG 191018) 30 November 2018 (for ARTG 188775) 31 August 2017 (for ARTG 203625) | 16/08/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69. | The products do not have the current sponsor address printed on the labels. | The labels to which this consent applies are those previously approved where the product labels bear the former sponsor address and that arrangements are in place to redirect all mail to the new sponsor address. | Supply | Prescription medicines |
| WATER FOR INJECTIONS BP, water for injections, 5 mL, solution for injection, ampoule | Fresenius Kabi Australia Pty Ltd | 198332 | 20KCB002 | CON-202 | The consent is effective from the 16 August 2017 to: 31 October 2017 (for ARTG 29771) 31 August 2017 (for ARTG 29790) 31 December 2017 (for ARTG 29599) 30 November 2017 (for ARTG 198332) 31 January 2018 (for ARTG 197200) 31 August 2018 (for ARTG 211732) 31 August 2018 (for ARTG 213304) 31 January 2018 (for ARTG 191018) 30 November 2018 (for ARTG 188775) 31 August 2017 (for ARTG 203625) | 16/08/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69. | The products do not have the current sponsor address printed on the labels. | The labels to which this consent applies are those previously approved where the product labels bear the former sponsor address and that arrangements are in place to redirect all mail to the new sponsor address. | Supply | Prescription medicines |
| GLUCOSE 5% 25 g/500 mL injection bag | Fresenius Kabi Australia Pty Ltd | 29599 | 14KD7329 | CON-202 | The consent is effective from the 16 August 2017 to: 31 October 2017 (for ARTG 29771) 31 August 2017 (for ARTG 29790) 31 December 2017 (for ARTG 29599) 30 November 2017 (for ARTG 198332) 31 January 2018 (for ARTG 197200) 31 August 2018 (for ARTG 211732) 31 August 2018 (for ARTG 213304) 31 January 2018 (for ARTG 191018) 30 November 2018 (for ARTG 188775) 31 August 2017 (for ARTG 203625) | 16/08/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69. | The products do not have the current sponsor address printed on the labels. | The labels to which this consent applies are those previously approved where the product labels bear the former sponsor address and that arrangements are in place to redirect all mail to the new sponsor address. | Supply | Prescription medicines |
| GLUCOSE 10% 50 g/500 mL injection bag | Fresenius Kabi Australia Pty Ltd | 29790 | 14KK7321 | CON-202 | The consent is effective from the 16 August 2017 to: 31 October 2017 (for ARTG 29771) 31 August 2017 (for ARTG 29790) 31 December 2017 (for ARTG 29599) 30 November 2017 (for ARTG 198332) 31 January 2018 (for ARTG 197200) 31 August 2018 (for ARTG 211732) 31 August 2018 (for ARTG 213304) 31 January 2018 (for ARTG 191018) 30 November 2018 (for ARTG 188775) 31 August 2017 (for ARTG 203625) | 16/08/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69. | The products do not have the current sponsor address printed on the labels. | The labels to which this consent applies are those previously approved where the product labels bear the former sponsor address and that arrangements are in place to redirect all mail to the new sponsor address. | Supply | Prescription medicines |
| COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) 500 mL injection bag | Fresenius Kabi Australia Pty Ltd | 29771 | 14KC7322 | CON-202 | The consent is effective from the 16 August 2017 to: 31 October 2017 (for ARTG 29771) 31 August 2017 (for ARTG 29790) 31 December 2017 (for ARTG 29599) 30 November 2017 (for ARTG 198332) 31 January 2018 (for ARTG 197200) 31 August 2018 (for ARTG 211732) 31 August 2018 (for ARTG 213304) 31 January 2018 (for ARTG 191018) 30 November 2018 (for ARTG 188775) 31 August 2017 (for ARTG 203625) | 16/08/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69. | The products do not have the current sponsor address printed on the labels. | The labels to which this consent applies are those previously approved where the product labels bear the former sponsor address and that arrangements are in place to redirect all mail to the new sponsor address. | Supply | Prescription medicines |
| MYAMBUTOL ethambutol hydrochloride 100 mg tablet bottle | Aspen Pharma Pty Ltd | 47887 | CON-204 | The consent is effective from the 18 August 2017 until 18 August 2019. | 18/08/2017 | Sections 8(1)(a), (h), (i), (j), (o); 8(2); 9(1)(a); 9(2) and 9(3) of the Therapeutic Goods Order No. 91. | The UK labelled product does not bear%2358; The Australian registered name of the medicine. The Australian approved storage condition. The name and contact details of the Australian sponsor or Australian distributor of the medicine on the bottle label only. A declaration of the presence of substances referred to in Schedule. The Australian registered name of the medicine on three non-opposing side of the carton. Space for a pharmacy dispensing label on the carton label. The name of the medicine and, the name and quantity of the active ingredient as a cohesive unit on the main label. | 1. The UK bottle and carton labels to which this consent applies are those provided withtheletter of application.2. The carton label will be over-labelled with a sticker stating the Australian sponsor’s name and address and, AUST R number.3. The ‘Dear Doctor’, ‘Dear Pharmacist’ and ‘Dear Wholesaler’ letters, identical to that provided withtheemail dated 4 August 2017, will be sent to the relevant stakeholders advising the reason for supplying UK-packaged stock in Australia and that this product must be stored under Australian approved storage condition, i.e. ‘store below 25°C’. | Import and supply | Prescription medicines | |
| QUADRACEL 0.5 mL injection vial | Sanofi Aventis Australia Pty Ltd | 91355 | C5324 - 150,000 doses only | CON-205 | The consent is effective from the 23 August 2017 until 8 November 2019. | 23/08/2017 | European Pharmacopoeia | The productis tested to the United States, rather than Australian specifications, as detailed in the application letter. | 1. This consent applies only to 150,000 doses from Quadracel C5324.2.Non”compliance with the European Pharmacopoeia requirements is limited to the tests detailed in the application;3. The doses will be labelled in the Australian approved labels (carton, vial and package insert);4. The company will provide TGA with a copy of the Release Certificate of the relevant bulk from US CBER;5. Normal TGA batch release processes will apply to this batch. | Import and supply | Prescription medicines |
| Beeotic Prebiotic Honey | Capilano Honey Ltd | 287980 | CON-206 | The consent is effective from the 24 August 2017 until 24 August 2019. | 24/08/2017 | Section 8 of the Therapeutic Goods Order No. 77 – Microbiological Standards for Medicines | The product does not comply with the prescribed requirements of the British Pharmacopoeia (BP) preservative efficacy test acceptance criteria (Appendix XVI C, Criteria B (Table 5.1.3.3)) for log10 reductions of ‘challenge organisms’ in particular Escherichia coli, and Aspergillus brasiliensis, as mandated by section 8 of the TGO77. | Supply and export | Listed complementary medicines | ||
| BRUFEN ibuprofen 400 mg tablet blister pack | Mylan Health Pty Ltd | 80659 | CON-208 | The consent is effective from the 4 September 2017 until 14 April 2019. | 4/09/2017 | Subsection 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The carton and blister foil labels do not bear the current sponsor's name and address. | The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address. | Import and supply | Prescription medicines | |
| LUVOX fluvoxamine maleate 100 mg tablet blister pack | Mylan Health Pty Ltd | 57633 | CON-208 | The consent is effective from the 4 September 2017 until 14 April 2019. | 4/09/2017 | Subsection 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The carton and blister foil labels do not bear the current sponsor's name and address. | The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address. | Import and supply | Prescription medicines | |
| LUVOX fluvoxamine maleate 50 mg tablet blister pack | Mylan Health Pty Ltd | 57632 | CON-208 | The consent is effective from the 4 September 2017 until 14 April 2019. | 4/09/2017 | Subsection 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The carton and blister foil labels do not bear the current sponsor's name and address. | The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address. | Import and supply | Prescription medicines | |
| FENOFIBRATE MYLAN fenofibrate 48 mg tablet blister pack | Mylan Health Pty Ltd | 230444 | CON-208 | The consent is effective from the 4 September 2017 until 14 April 2019. | 4/09/2017 | Subsection 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The carton and blister foil labels do not bear the current sponsor's name and address. | The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address. | Import and supply | Prescription medicines | |
| FENOFIBRATE MYLAN fenofibrate 145 mg tablet blister pack | Mylan Health Pty Ltd | 230443 | CON-208 | The consent is effective from the 4 September 2017 until 14 April 2019. | 4/09/2017 | Subsection 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The carton and blister foil labels do not bear the current sponsor's name and address. | The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address. | Import and supply | Prescription medicines | |
| LIPIDIL fenofibrate 48 mg tablet blister pack | Mylan Health Pty Ltd | 118642 | CON-208 | The consent is effective from the 4 September 2017 until 14 April 2019. | 4/09/2017 | Subsection 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The carton and blister foil labels do not bear the current sponsor's name and address. | The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address. | Import and supply | Prescription medicines | |
| LIPIDIL fenofibrate 145 mg tablet blister pack | Mylan Health Pty Ltd | 118634 | CON-208 | The consent is effective from the 4 September 2017 until 14 April 2019. | 4/09/2017 | Subsection 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The carton and blister foil labels do not bear the current sponsor's name and address. | The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address. | Import and supply | Prescription medicines | |
| TRICHODIL fenofibrate 48 mg tablet blister pack | Mylan Health Pty Ltd | 233991 | CON-208 | The consent is effective from the 4 September 2017 until 14 April 2019. | 4/09/2017 | Subsection 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The carton and blister foil labels do not bear the current sponsor's name and address. | The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address. | Import and supply | Prescription medicines | |
| TRICHODIL fenofibrate 145 mg tablet blister pack | Mylan Health Pty Ltd | 233990 | CON-208 | The consent is effective from the 4 September 2017 until 14 April 2019. | 4/09/2017 | Subsection 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The carton and blister foil labels do not bear the current sponsor's name and address. | The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address. | Import and supply | Prescription medicines | |
| FENOFIB fenofibrate 48 mg tablet blister pack | Mylan Health Pty Ltd | 233989 | CON-208 | The consent is effective from the 4 September 2017 until 14 April 2019. | 4/09/2017 | Subsection 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The carton and blister foil labels do not bear the current sponsor's name and address. | The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address. | Import and supply | Prescription medicines | |
| FENOFIB fenofibrate 145 mg tablet blister pack | Mylan Health Pty Ltd | 233988 | CON-208 | The consent is effective from the 4 September 2017 until 14 April 2019. | 4/09/2017 | Subsection 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The carton and blister foil labels do not bear the current sponsor's name and address. | The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address. | Import and supply | Prescription medicines | |
| TEVETEN eprosartan 600 mg (as mesilate) tablet blister pack | Mylan Health Pty Ltd | 73779 | CON-208 | The consent is effective from the 4 September 2017 until 14 April 2019. | 4/09/2017 | Subsection 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The carton and blister foil labels do not bear the current sponsor's name and address. | The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address. | Import and supply | Prescription medicines | |
| TEVETEN eprosartan 400 mg (as mesilate) tablet blister pack | Mylan Health Pty Ltd | 64400 | CON-208 | The consent is effective from the 4 September 2017 until 14 April 2019. | 4/09/2017 | Subsection 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The carton and blister foil labels do not bear the current sponsor's name and address. | The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address. | Import and supply | Prescription medicines | |
| TEVETEN PLUS 600/12.5 eprosartan 600 mg/hydrochlorothiazide 12.5 mg tablet blister pack | Mylan Health Pty Ltd | 143172 | CON-208 | The consent is effective from the 4 September 2017 until 14 April 2019. | 4/09/2017 | Subsection 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The carton and blister foil labels do not bear the current sponsor's name and address. | The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address. | Import and supply | Prescription medicines | |
| Necessity Fixaderm Lotion | Toowoomba Maranatha Foundation | 179095 | CON-207 | The consent is effective from the 4 September 2017 until 04 September 2019. | 4/09/2017 | Sections 7(1) and 8(1)(i) of the Therapeutic Goods Order No. 92 – (TGO 92)-Standard for labels of non prescription medicines | Section 7(1) requires the labels on the containerand primary pack to comply with the requirements of the Order. Section 8(1)(i) requires the name and contact details of the sponsor or distributor on the labels. | Supply | Listed complementary medicines | ||
| CURAM DUO FORTE 875/125 amoxicillin 875 mg (as trihydrate) and clavulanic acid 125 mg (as potassium) tablet strip pack | Sandoz Pty Ltd | 82829 | HB8086 and HB8087 | CON-209 | The consent is effective from the 5 September 2017 until the batches HB8086 and HB8087 are depleted. | 5/09/2017 | Subclauses 3(2)(h) and (i) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The foil strip label does not include batch number and expiry date prefixes immediately followed by the batch number and expiry date. | A ‘Dear Healthcare Professional’ letter identical to that provided to the TGA in your s31 response will be supplied with each affected batch to individual pharmacy to ensure that the patients are instructed to keep the foil strips in the product pack for these affected batches. | Import and supply | Prescription medicines |
| HYDRALAZINE LINK hydralazine hydrochloride 20 mg/1 mL solution for injection vial | Link Medical Products Pty Ltd | 272644 | CON-210 | The consent is effective from 21 September 2017 until 5 June 2019. | 21/09/2017 | Non- compliant with the requirements of TGO 89 Standard for Water for Injections for Parenteral Materials. | The water is notproduced by the method of manufacture stated in the British Pharmacopoeia or the European Pharmacopoeia. | The products conform with the agreed method of manufacture of water for injections at the agreed manufacturing site and that the water for injections conform with the agreed tests and limits. | Supply | Prescription medicines | |
| IOPIDINE apraclonidine 5 mg/mL (as hydrochloride) eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 51190 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| ILEVRO nepafenac 0.3% eye drops, suspension, bottle | Novartis Pharmaceuticals Australia Pty Ltd | 230200 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| FLUORESCITE fluorescein 10% 500 mg/5 mL (as sodium) injection vial | Novartis Pharmaceuticals Australia Pty Ltd | 124267 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| FLUCON fluorometholone 1 mg/mL Eye Drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 25275 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| FLAREX fluorometholone acetate 1 mg/mL eye drops suspension bottle | Novartis Pharmaceuticals Australia Pty Ltd | 25278 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| DUOTRAV travoprost 0.004% and timolol 0.5% (as maleate) eye drop solution bottle | Novartis Pharmaceuticals Australia Pty Ltd | 177772 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| CYCLOGYL cyclopentolate hydrochloride 1% eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 25273 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| CIPROXIN HC EAR DROPS 0.2% ciprofloxacin (as hydrochloride) and 1% hydrocortisone ear drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 136662 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| CILOXAN ciprofloxacin 3 mg/mL (as hydrochloride) ear drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 121897 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| CILOQUIN ciprofloxacin 3 mg/mL (as hydrochloride) ear drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 121898 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| CILOXAN ciprofloxacin 3 mg/mL (as hydrochloride) eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 42899 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| BRINZOQUIN 1.0% brinzolamide 10 mg/mL eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 99179 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| BRINZOLAMIDE SANDOZ 1.0% brinzolamide 10 mg/mL eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 218986 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| BETOQUIN betaxolol 5.0 mg/mL (as hydrochloride) eye drops solution bottle | Novartis Pharmaceuticals Australia Pty Ltd | 55618 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| BETOPTIC S betaxolol 0.25% 2.5 mg/mL (as hydrochloride) eye drops suspension bottle | Novartis Pharmaceuticals Australia Pty Ltd | 42900 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| BETOPTIC betaxolol 5 mg/ mL (as hydrochloride) eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 25272 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| AZOPT 1.0% brinzolamide 10 mg/mL eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 72750 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| AZARGA brinzolamide 1% and timolol 0.5% eye drops | Novartis Pharmaceuticals Australia Pty Ltd | 156500 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| ALCAINE proxymetacaine hydrochloride 0.5% eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 24299 | CON-212 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 | The product labels do not bear current sponsors name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No .69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| VOLTAREN OPHTHA diclofenac sodium 1 mg/mL eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 96654 | CON-211 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 ” General requirements for labels for medicines. | The product labels do not bear current sponsor’s name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No.69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| TRAVOPROST SANDOZ 0.004% travoprost 40 microgram/mL eye drop solution bottle | Novartis Pharmaceuticals Australia Pty Ltd | 278721 | CON-211 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 ” General requirements for labels for medicines. | The product labels do not bear current sponsor’s name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No.69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| TRAVOPROST/TIMOLOL SANDOZ 40/5 travoprost 40 microgram/mL and timolol (as maleate) 5 mg/mL eye drop solution bottle | Novartis Pharmaceuticals Australia Pty Ltd | 277959 | CON-211 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 ” General requirements for labels for medicines. | The product labels do not bear current sponsor’s name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No.69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| TRAVATAN 0.004% travoprost 40 microgram/mL eye drop solution bottle | Novartis Pharmaceuticals Australia Pty Ltd | 173354 | CON-211 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 ” General requirements for labels for medicines. | The product labels do not bear current sponsor’s name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No.69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| TOBREX tobramycin 3 mg/g eye ointment tube | Novartis Pharmaceuticals Australia Pty Ltd | 25364 | CON-211 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 ” General requirements for labels for medicines. | The product labels do not bear current sponsor’s name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No.69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| TOBREX tobramycin 3 mg/mL eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 25365 | CON-211 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 ” General requirements for labels for medicines. | The product labels do not bear current sponsor’s name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No.69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| SIMBRINZA 1%/0.2% brinzolamide 1% and brimonidine tartrate 0.2% eye drops suspension bottle | Novartis Pharmaceuticals Australia Pty Ltd | 219839 | CON-211 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 ” General requirements for labels for medicines. | The product labels do not bear current sponsor’s name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No.69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| RetAAne anecortave acetate 15 mg/0.5 mL injection suspension vial | Novartis Pharmaceuticals Australia Pty Ltd | 115599 | CON-211 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 ” General requirements for labels for medicines. | The product labels do not bear current sponsor’s name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No.69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| PATANOL 0.1% olopatadine hydrochloride 1.11 mg/1 mL eye drop bottle | Novartis Pharmaceuticals Australia Pty Ltd | 82000 | CON-211 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 ” General requirements for labels for medicines. | The product labels do not bear current sponsor’s name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No.69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| MYDRIACYL tropicamide 1% eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 25357 | CON-211 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 ” General requirements for labels for medicines. | The product labels do not bear current sponsor’s name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No.69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| MYDRIACYL tropicamide 0.5% eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 25356 | CON-211 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 ” General requirements for labels for medicines. | The product labels do not bear current sponsor’s name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No.69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| MAXIDEX dexamethasone 0.1% eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 25354 | CON-211 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 ” General requirements for labels for medicines. | The product labels do not bear current sponsor’s name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No.69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| IZBA travoprost 30 microgram/ mL eye drops solution bottle | Novartis Pharmaceuticals Australia Pty Ltd | 263496 | CON-211 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 ” General requirements for labels for medicines. | The product labels do not bear current sponsor’s name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No.69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| ISOPTO CARPINE pilocarpine hydrochloride 4% eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 25297 | CON-211 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 ” General requirements for labels for medicines. | The product labels do not bear current sponsor’s name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No.69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| ISOPTO CARPINE pilocarpine hydrochloride 2% eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 25295 | CON-211 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 ” General requirements for labels for medicines. | The product labels do not bear current sponsor’s name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No.69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| ISOPTO CARPINE pilocarpine hydrochloride 1% eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 25294 | CON-211 | The consent is effective from the 4 October 2017 until 4 October 2019. | 4/10/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 ” General requirements for labels for medicines. | The product labels do not bear current sponsor’s name and address. | The labels to which this consent applies are those approved under Therapeutic Goods Order No.69 for the former sponsor Alcon Laboratories (Australia) Pty Ltd and arrangements are in place to redirect any correspondence to current sponsor Novartis Pharmaceuticals Australia Pty Ltd. | Import and supply | Prescription medicines | |
| HYQVIA - Normal Immunoglobulin Infusion 10% (Human) with Vorhyaluronidase alfa, Injection solution for subcutaneous use | Baxalta Australia Pty Ltd | 235178 | CON-214 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| FEIBA-NF factor eight inhibitor bypassing fraction 1000 U powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 104911 | CON-214 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| FEIBA-NF factor VIII inhibitor bypassing fraction 2500 U powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 172236 | CON-214 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| FEIBA-NF factor eight inhibitor bypassing fraction 500 U powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 104896 | CON-214 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| CEPROTIN protein c 500 IU powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 104537 | CON-214 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| CEPROTIN protein c 1000 IU powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 104538 | CON-214 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| ADYNOVATE rurioctocog alfa pegol 500 IU powder for injection vial | Baxalta Australia Pty Ltd | 278727 | CON-214 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| ADYNOVATE rurioctocog alfa pegol 250 IU powder for injection vial | Baxalta Australia Pty Ltd | 273517 | CON-214 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| ADYNOVATE rurioctocog alfa pegol 2000 IU powder for injection vial | Baxalta Australia Pty Ltd | 278729 | CON-214 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| ADYNOVATE rurioctocog alfa pegol 1000 IU powder for injection vial | Baxalta Australia Pty Ltd | 278728 | CON-214 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| ADVATE octocog alfa (rch) 500 IU powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 100385 | CON-214 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| ADVATE octocog alfa (rch) 4000 IU powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 214709 | CON-214 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| ADVATE octocog alfa (rch) 3000 IU powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 150366 | CON-214 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| ADVATE octocog alfa (rch) 250 IU powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 100384 | CON-214 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| ADVATE octocog alfa (rch) 2000 IU powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 136204 | CON-214 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| ADVATE octocog alfa (rch) 1500 IU powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 100387 | CON-214 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| ADVATE octocog alfa (rch) 1000 IU powder for injection vial with diluent vial | Baxalta Australia Pty Ltd | 100386 | CON-214 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines. | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| RECOMBINATE octocog alfa (rch) 1000 IU powder for injection vial and diluent vial | Baxalta Australia Pty Ltd | 65858 | CON-213 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| ONIVYDE irinotecan (as sucrosofate) 43 mg/10 mL nanoliposomal concentrated injection for infusion | Baxalta Australia Pty Ltd | 263184 | CON-213 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| RIXUBIS nonacog gamma (rch) 2000 IU powder and solvent for solution for injection glass vials | Baxalta Australia Pty Ltd | 204768 | CON-213 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| RIXUBIS nonacog gamma (rch) 1000 IU powder and solvent for solution for injection glass vials | Baxalta Australia Pty Ltd | 204766 | CON-213 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| RIXUBIS nonacog gamma (rch) 3000 IU powder and solvent for solution for injection glass vials | Baxalta Australia Pty Ltd | 204765 | CON-213 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| RIXUBIS nonacog gamma (rch) 500 IU powder and solvent for solution for injection glass vials | Baxalta Australia Pty Ltd | 204769 | CON-213 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| RIXUBIS nonacog gamma (rch) 250 IU powder and solvent for solution for injection glass vials | Baxalta Australia Pty Ltd | 204767 | CON-213 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| RECOMBINATE octocog alfa (rch) 500 IU powder for injection vial and diluent vial | Baxalta Australia Pty Ltd | 65857 | CON-213 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| RECOMBINATE octocog alfa (rch) 250 IU powder for injection vial and diluent vial | Baxalta Australia Pty Ltd | 65814 | CON-213 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| OBIZUR susoctocog alfa (bhk) 500U antihemophilic factor (recombinant), porcine sequence powder for injection vial with water for injection syringe | Baxalta Australia Pty Ltd | 236475 | CON-213 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| KIOVIG normal immunoglobulin (human) 30 g/300 mL solution for injection vial | Baxalta Australia Pty Ltd | 198488 | CON-213 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| KIOVIG normal immunoglobulin (human) 2.5 g/25 mL solution for injection vial | Baxalta Australia Pty Ltd | 131966 | CON-213 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| KIOVIG normal immunoglobulin (human) 5 g/50 mL solution for injection vial | Baxalta Australia Pty Ltd | 131968 | CON-213 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| KIOVIG normal immunoglobulin (human) 1 g/10 mL solution for injection vial | Baxalta Australia Pty Ltd | 131953 | CON-213 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| KIOVIG normal immunoglobulin (human) 10 g/100 mL solution for injection vial | Baxalta Australia Pty Ltd | 131969 | CON-213 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| KIOVIG normal immunoglobulin (human) 20 g/200 mL solution for injection vial | Baxalta Australia Pty Ltd | 131973 | CON-213 | The consent is effective from the 18 October 2017 until 31 October 2019. | 18/10/2017 | Subclause 3(2)(l) of Therapeutic Goods Order No 69-General requirements for labels for medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| ADRENALINE-LINK 1:10,000 1 mg/10 mL adrenaline (epinephrine) acid tartrate injection BP pre filled syringe | Link Pharmaceuticals | 210672 | CON-220 | The consent is effective from the 30 October 2017 until 31 January 2018. | 30/10/2017 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines. | Do not bear the Australian name of the medicine (paragraphs 8(1)(a), 9(1)(a) and 10(4)(c) of TGO 91). Do not have the name of the medicine and the name and quantity of the active ingredient displayed as a 'cohesive unit' on the main label as detailed in subections 9(2) and 9(3) of TGO 91. Do not bear the approved route of administration (paragraphs 8(1)(m), 9(1)(f) and 10(4)(k) of TGO 91). Do not bear the statements 'Use in one patient on one occasion only. Contains no antimicrobial preservative' (paragraph 10(3)(b) of TGO 91). Do not have the name of the medicine displayed on at least three non-opposing sides of the carton (paragraph 8(1)(o) of TGO 91). The UK carton label does not express the name and quantity of each excipient in the medicine (paragraph 10(3)(a) of TGO 91). The label for the prefilled syringe does not bear the name or registered trademark of the Australian sponsor or the Australian distributor (paragraph 10(4)(j) of TGO 91). | A 'Dear Healthcare Professional letter identical to that provided to the Therapeutic Goods Administration on 25 October 2017 will be supplied with the affected product, informing that the product is packaged with UK labelling and advising the Healthcare Professionals of the differences between the UK labelling, including packaging insert, and the Australian approved product. In particular, that this product is for intravenous use only. The labels (i.e. UK carton, carton closure and prefilled syringe labels) to which this consent applies are those provided with the letter of application, where the carton label includes an over-sticker that details the Australian sponsor's name and contact details (address, phone, fax and email), and the AUST R number. | Import and supply | Prescription medicines | |
| TERRY WHITE CHEMISTS ANTI-INFLAMMATORY PAIN RELIEF TABLETS diclofenac sodium 25 mg enteric coated tablet blister pack | Apotex Pty Ltd | 287706 | 370561A | CON-222 | The consent is effective from the 8 November 2017 until 1 September 2019. | 8/11/2017 | Paragraph 10(9)(c) of the Therapeutic Goods Order No. 92 – Standards for labels of non-prescription medicines (TGO 92) | The name of the medicine, the name of the active ingredient and the quantity of the active ingredient do not appear in relation to the two tablets located at the end of the right hand side of the blister strip. | Import and supply | Over-the-counter medicines | |
| BLOOMS THE CHEMIST ANTI-INFLAMMATORY PAIN RELIEF TABLETS diclofenac sodium 25 mg enteric coated tablet blister pack | Apotex Pty Ltd | 287705 | 370559 | CON-222 | The consent is effective from the 8 November 2017 until 1 September 2019. | 8/11/2017 | Paragraph 10(9)(c) of the Therapeutic Goods Order No. 92 – Standards for labels of non-prescription medicines (TGO 92) | The name of the medicine, the name of the active ingredient and the quantity of the active ingredient do not appear in relation to the two tablets located at the end of the right hand side of the blister strip. | Import and supply | Over-the-counter medicines | |
| ZANIDIP lercanidipine hydrochloride 20 mg film coated tablet blister pack | Mylan Health Pty Ltd | 93733 | CON-226 | The consent is effective from the 10 November 2017 until 14 April 2019. | 10/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not display current sponsor's name and address. | 1. The sponsor has set-up re-direction of all mails addressed to BGP Products Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Abbott and Mylan Health Pty Ltd is in place to ensure all email and/or telephone contact inadvertently made to Abbott regarding a product of Mylan Health is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| COLOFAC mebeverine hydrochloride 135 mg tablet blister pack | Mylan Health Pty Ltd | 79335 | CON-226 | The consent is effective from the 10 November 2017 until 14 April 2019. | 10/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not display current sponsor's name and address. | 1. The sponsor has set-up re-direction of all mails addressed to BGP Products Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Abbott and Mylan Health Pty Ltd is in place to ensure all email and/or telephone contact inadvertently made to Abbott regarding a product of Mylan Health is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| ZANIDIP lercanidipine hydrochloride 10 mg film coated tablet blister pack | Mylan Health Pty Ltd | 77506 | CON-226 | The consent is effective from the 10 November 2017 until 14 April 2019. | 10/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not display current sponsor's name and address. | 1. The sponsor has set-up re-direction of all mails addressed to BGP Products Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Abbott and Mylan Health Pty Ltd is in place to ensure all email and/or telephone contact inadvertently made to Abbott regarding a product of Mylan Health is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| LERCANIDIPINE SANDOZ lercanidipine hydrochloride 20 mg film coated tablet blister pack | Mylan Health Pty Ltd | 165914 | CON-226 | The consent is effective from the 10 November 2017 until 14 April 2019. | 10/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not display current sponsor's name and address. | 1. The sponsor has set-up re-direction of all mails addressed to BGP Products Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Abbott and Mylan Health Pty Ltd is in place to ensure all email and/or telephone contact inadvertently made to Abbott regarding a product of Mylan Health is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| LERCANIDIPINE SANDOZ lercanidipine hydrochloride 10 mg film coated tablet blister pack | Mylan Health Pty Ltd | 165913 | CON-226 | The consent is effective from the 10 November 2017 until 14 April 2019. | 10/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not display current sponsor's name and address. | 1. The sponsor has set-up re-direction of all mails addressed to BGP Products Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Abbott and Mylan Health Pty Ltd is in place to ensure all email and/or telephone contact inadvertently made to Abbott regarding a product of Mylan Health is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| OMACOR (omega-3-acid ethyl esters 90) 1000 mg soft capsule bottle | Mylan Health Pty Ltd | 155717 | CON-226 | The consent is effective from the 10 November 2017 until 14 April 2019. | 10/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not display current sponsor's name and address. | 1. The sponsor has set-up re-direction of all mails addressed to BGP Products Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Abbott and Mylan Health Pty Ltd is in place to ensure all email and/or telephone contact inadvertently made to Abbott regarding a product of Mylan Health is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| LERCADIP lercanidipine hydrochloride 20 mg tablet blister pack | Mylan Health Pty Ltd | 152710 | CON-226 | The consent is effective from the 10 November 2017 until 14 April 2019. | 10/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not display current sponsor's name and address. | 1. The sponsor has set-up re-direction of all mails addressed to BGP Products Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Abbott and Mylan Health Pty Ltd is in place to ensure all email and/or telephone contact inadvertently made to Abbott regarding a product of Mylan Health is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| LERCADIP lercanidipine hydrochloride 10 mg tablet blister pack | Mylan Health Pty Ltd | 152709 | CON-226 | The consent is effective from the 10 November 2017 until 14 April 2019. | 10/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not display current sponsor's name and address. | 1. The sponsor has set-up re-direction of all mails addressed to BGP Products Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Abbott and Mylan Health Pty Ltd is in place to ensure all email and/or telephone contact inadvertently made to Abbott regarding a product of Mylan Health is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| LERCAN lercanidipine hydrochloride 20 mg tablet blister pack | Mylan Health Pty Ltd | 152708 | CON-226 | The consent is effective from the 10 November 2017 until 14 April 2019. | 10/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not display current sponsor's name and address. | 1. The sponsor has set-up re-direction of all mails addressed to BGP Products Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Abbott and Mylan Health Pty Ltd is in place to ensure all email and/or telephone contact inadvertently made to Abbott regarding a product of Mylan Health is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| LERCAN lercanidipine hydrochloride 10 mg tablet blister pack | Mylan Health Pty Ltd | 152707 | CON-226 | The consent is effective from the 10 November 2017 until 14 April 2019. | 10/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not display current sponsor's name and address. | 1. The sponsor has set-up re-direction of all mails addressed to BGP Products Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Abbott and Mylan Health Pty Ltd is in place to ensure all email and/or telephone contact inadvertently made to Abbott regarding a product of Mylan Health is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| ZAN-EXTRA 10/20 lercanidipine hydrochloride 10 mg and enalapril maleate 20 mg film coated tablets blister pack | Mylan Health Pty Ltd | 120961 | CON-226 | The consent is effective from the 10 November 2017 until 14 April 2019. | 10/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not display current sponsor's name and address. | 1. The sponsor has set-up re-direction of all mails addressed to BGP Products Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Abbott and Mylan Health Pty Ltd is in place to ensure all email and/or telephone contact inadvertently made to Abbott regarding a product of Mylan Health is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| ZAN-EXTRA 10/10 lercanidipine hydrochloride 10 mg and enalapril maleate 10 mg film coated tablets blister pack | Mylan Health Pty Ltd | 120955 | CON-226 | The consent is effective from the 10 November 2017 until 14 April 2019. | 10/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not display current sponsor's name and address. | 1. The sponsor has set-up re-direction of all mails addressed to BGP Products Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Abbott and Mylan Health Pty Ltd is in place to ensure all email and/or telephone contact inadvertently made to Abbott regarding a product of Mylan Health is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| NORMATENS moxonidine 400 microgram tablet blister pack | Mylan Health Pty Ltd | 114124 | CON-226 | The consent is effective from the 10 November 2017 until 14 April 2019. | 10/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not display current sponsor's name and address. | 1. The sponsor has set-up re-direction of all mails addressed to BGP Products Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Abbott and Mylan Health Pty Ltd is in place to ensure all email and/or telephone contact inadvertently made to Abbott regarding a product of Mylan Health is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| NORMATENS moxonidine 200 microgram tablet blister pack | Mylan Health Pty Ltd | 114122 | CON-226 | The consent is effective from the 10 November 2017 until 14 April 2019. | 10/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not display current sponsor's name and address. | 1. The sponsor has set-up re-direction of all mails addressed to BGP Products Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Abbott and Mylan Health Pty Ltd is in place to ensure all email and/or telephone contact inadvertently made to Abbott regarding a product of Mylan Health is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| PHYSIOTENS moxonidine 400 microgram tablet blister pack | Mylan Health Pty Ltd | 114121 | CON-226 | The consent is effective from the 10 November 2017 until 14 April 2019. | 10/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not display current sponsor's name and address. | 1. The sponsor has set-up re-direction of all mails addressed to BGP Products Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Abbott and Mylan Health Pty Ltd is in place to ensure all email and/or telephone contact inadvertently made to Abbott regarding a product of Mylan Health is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| PHYSIOTENS moxonidine 200 microgram tablet blister pack | Mylan Health Pty Ltd | 114119 | CON-226 | The consent is effective from the 10 November 2017 until 14 April 2019. | 10/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product labels do not display current sponsor's name and address. | 1. The sponsor has set-up re-direction of all mails addressed to BGP Products Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Abbott and Mylan Health Pty Ltd is in place to ensure all email and/or telephone contact inadvertently made to Abbott regarding a product of Mylan Health is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| KLACID clarithromycin 250 mg tablet bottle | Mylan Health Pty Ltd | 79576 | CON-227 | The consent is effective from the the 15 November 2017 until 14 April 2019. | 15/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former name and address BGP products Pty Ltd, 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Import and supply | Prescription medicines | |
| KLACID clarithromycin 250 mg tablet blister pack | Mylan Health Pty Ltd | 79564 | CON-227 | The consent is effective from the the 15 November 2017 until 14 April 2019. | 15/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former name and address BGP products Pty Ltd, 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Import and supply | Prescription medicines | |
| FEMOSTON-CONTI tablet blister pack | Mylan Health Pty Ltd | 78654 | CON-227 | The consent is effective from the the 15 November 2017 until 14 April 2019. | 15/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former name and address BGP products Pty Ltd, 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Import and supply | Prescription medicines | |
| FEMOSTON 2/10 estradiol 2 mg and estradiol 2 mg with dydrogesterone 10 mg tablet blister pack composite pack | Mylan Health Pty Ltd | 75889 | CON-227 | The consent is effective from the the 15 November 2017 until 14 April 2019. | 15/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former name and address BGP products Pty Ltd, 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Import and supply | Prescription medicines | |
| ISOPTIN verapamil hydrochloride 80 mg tablet blister pack | Mylan Health Pty Ltd | 65503 | CON-227 | The consent is effective from the the 15 November 2017 until 14 April 2019. | 15/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former name and address BGP products Pty Ltd, 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Import and supply | Prescription medicines | |
| ISOPTIN verapamil hydrochloride 40 mg tablet blister pack | Mylan Health Pty Ltd | 65502 | CON-227 | The consent is effective from the the 15 November 2017 until 14 April 2019. | 15/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former name and address BGP products Pty Ltd, 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Import and supply | Prescription medicines | |
| SERC Betahistine dihydrochloride 16 mg tablet blister pack | Mylan Health Pty Ltd | 61687 | CON-227 | The consent is effective from the the 15 November 2017 until 14 April 2019. | 15/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former name and address BGP products Pty Ltd, 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Import and supply | Prescription medicines | |
| KLACID clarithromycin 250 mg/5 mL powder for oral liquid bottle | Mylan Health Pty Ltd | 56729 | CON-227 | The consent is effective from the the 15 November 2017 until 14 April 2019. | 15/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former name and address BGP products Pty Ltd, 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Import and supply | Prescription medicines | |
| CORDILOX 180 SR verapamil hydrochloride 180 mg tablet blister pack | Mylan Health Pty Ltd | 54033 | CON-227 | The consent is effective from the the 15 November 2017 until 14 April 2019. | 15/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former name and address BGP products Pty Ltd, 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Import and supply | Prescription medicines | |
| ISOPTIN 180 SR 180 mg verapamil hydrochloride tablet blister pack | Mylan Health Pty Ltd | 54032 | CON-227 | The consent is effective from the the 15 November 2017 until 14 April 2019. | 15/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former name and address BGP products Pty Ltd, 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Import and supply | Prescription medicines | |
| KLACID clarithromycin 500 mg tablet blister pack | Mylan Health Pty Ltd | 52473 | CON-227 | The consent is effective from the the 15 November 2017 until 14 April 2019. | 15/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former name and address BGP products Pty Ltd, 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Import and supply | Prescription medicines | |
| KLACID clarithromycin 500 mg tablet bottle | Mylan Health Pty Ltd | 50682 | CON-227 | The consent is effective from the the 15 November 2017 until 14 April 2019. | 15/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former name and address BGP products Pty Ltd, 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Import and supply | Prescription medicines | |
| FEMOSTON 1/10 estradiol 1 mg and estradiol 1 mg with dydrogesterone 10 mg tablet blister pack composite pack | Mylan Health Pty Ltd | 219882 | CON-227 | The consent is effective from the the 15 November 2017 until 14 April 2019. | 15/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former name and address BGP products Pty Ltd, 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Import and supply | Prescription medicines | |
| ISOPTIN SR 240 mg verapamil hydrochloride tablet blister pack | Mylan Health Pty Ltd | 12801 | CON-227 | The consent is effective from the the 15 November 2017 until 14 April 2019. | 15/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former name and address BGP products Pty Ltd, 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Import and supply | Prescription medicines | |
| ISOPTIN verapamil hydrochloride 5 mg/2 mL injection | Mylan Health Pty Ltd | 12796 | CON-227 | The consent is effective from the the 15 November 2017 until 14 April 2019. | 15/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former name and address BGP products Pty Ltd, 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Import and supply | Prescription medicines | |
| CORDILOX SR verapamil hydrochloride 240 mg tablet | Mylan Health Pty Ltd | 10681 | CON-227 | The consent is effective from the the 15 November 2017 until 14 April 2019. | 15/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | The labels to which this consent applies are those previously approved for the former name and address BGP products Pty Ltd, 299 Lane Cove Road, Macquarie Park NSW 2113. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW 2000). | Import and supply | Prescription medicines | |
| CUVITRU normal immunoglobulin (human) infusion 20% for subcutaneous use in glass vial | Shire Australia Pty Ltd | 282579 | CON-223 | The consent is effective from 17 November 2017 until 31 October 2019. | 17/11/2017 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91-Standard for labels of prescription and related medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| ONCASPAR pegaspargase 3750 units/5 mL injection solution vial | Shire Australia Pty Ltd | 279831 | CON-223 | The consent is effective from 17 November 2017 until 31 October 2019. | 17/11/2017 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91-Standard for labels of prescription and related medicines | The labels do not include the name and address of the current sponsor or supplier of the goods. | The labels to which this consent applies are those previously approved for the outgoing sponsor Baxalta and arrangements are in place for the prompt referral of any queries or complaints concerning the products to Shire. | Import and supply | Prescription medicines | |
| ULTIVA Remifentanil (as hydrochloride) 5 mg powder for injection vial | Aspen Pharmacare Pty Ltd | 58690 | CON-228 | The consent is effective from the 20 November 2017 until 1 June 2018. | 20/11/2017 | Subsection 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | Arrangements are in place with the former sponsor GSK for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Pty Ltd | Import, supply and export | Prescription medicines | |
| ULTIVA Remifentanil (as hydrochloride) 2 mg powder for injection vial | Aspen Pharmacare Pty Ltd | 58689 | CON-228 | The consent is effective from the 20 November 2017 until 1 June 2018. | 20/11/2017 | Subsection 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | Arrangements are in place with the former sponsor GSK for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Pty Ltd | Import, supply and export | Prescription medicines | |
| ULTIVA Remifentanil (as hydrochloride) 1 mg powder for injection vial | Aspen Pharmacare Pty Ltd | 58688 | CON-228 | The consent is effective from the 20 November 2017 until 1 June 2018. | 20/11/2017 | Subsection 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The labels do not bear the current sponsor’s name and address. | Arrangements are in place with the former sponsor GSK for the prompt referral of any queries or complaints concerning the products to Aspen Pharmacare Pty Ltd | Import, supply and export | Prescription medicines | |
| SOLAVERT sotalol hydrochloride 160 mg tablet blister pack | Arrow Pharma Pty Ltd | 79918 | CON-224 | The consent is effective from the 20 November 2017 until 20 November 2018. | 20/11/2017 | Paragraph 8(1)(j) of the Therapeutic Goods Order No. 91 - Requirements for labels of prescription and related medicines | The product carton labels do not include a statement in relation to the declarable substance sugars, as set out in Column 2 of Schedule 1 of TGO 91. | Supply | Prescription medicines | ||
| SOLAVERT sotalol hydrochloride 80 mg tablet blister pack | Arrow Pharma Pty Ltd | 79916 | CON-224 | The consent is effective from the 20 November 2017 until 20 November 2018. | 20/11/2017 | Paragraph 8(1)(j) of the Therapeutic Goods Order No. 91 - Requirements for labels of prescription and related medicines | The product carton labels do not include a statement in relation to the declarable substance sugars, as set out in Column 2 of Schedule 1 of TGO 91. | Supply | Prescription medicines | ||
| SOTACOR sotalol hydrochloride 160 mg tablet blister pack | Arrow Pharma Pty Ltd | 68966 | CON-224 | The consent is effective from the 20 November 2017 until 20 November 2018. | 20/11/2017 | Paragraph 8(1)(j) of the Therapeutic Goods Order No. 91 - Requirements for labels of prescription and related medicines | The product carton labels do not include a statement in relation to the declarable substance sugars, as set out in Column 2 of Schedule 1 of TGO 91. | Supply | Prescription medicines | ||
| SOTACOR sotalol hydrochloride 80 mg tablet blister pack | Arrow Pharma Pty Ltd | 68964 | CON-224 | The consent is effective from the 20 November 2017 until 20 November 2018. | 20/11/2017 | Paragraph 8(1)(j) of the Therapeutic Goods Order No. 91 - Requirements for labels of prescription and related medicines | The product carton labels do not include a statement in relation to the declarable substance sugars, as set out in Column 2 of Schedule 1 of TGO 91. | Supply | Prescription medicines | ||
| Pharmacy Action Cold Sore Cream aciclovir 5% tube | Generic Health Pty Ltd | 194405 | CON-229 | The consent is effective from the 21 November 2017 until 23 November 2019. | 21/11/2017 | Subclauses 3(2)(c) and 4(10) of Therapeutic Goods Order No. 69 - General requirements for labels for medicines with regards to the expression of the quantity of the active ingredient | The active ingredient has been incorrectly expressed as 5% instead of 5% w/w in both the primary and secondary packaging. | Import and supply | Over-the-counter medicines | ||
| KETALAR ketamine 200 mg/2 mL (as hydrochloride) injection vial | Hospira Australia Pty Ltd | 70073 | CON-225 | The consent is effective from 21 November 2017 until 15 January 2018. | 21/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product carton labels do not bear the current Australian sponsor’s name and address. | A 'Dear Healthcare Provider' letter identical to that provided to the TGA in the correspondence dated 16 November 2017 will be supplied with each affected batch advising that as the ARTG product is out of stock, NZ stock has been used and the AUST R number and Australian sponsor details have been over stickered on these carton labels. | Supply | Prescription medicines | |
| REPLAGAL agalsidase alfa ghu 3.5 mg/3.5 mL concentrated injection vial | Shire Australia Pty Limited | 82818 | CON-231 | The consent is effective from the 23 November 2017 until 31 October 2019. | 23/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The product labels do not bear the current sponsor’s address. | The labels to which this consent applies are those previously approved for the former address Level 6, 123 Epping Road, North Ryde NSW 2113. Arrangements are in place for the prompt referral of any queries or complaints concerning the products to the current address (Level 39, 225 George Street, Sydney NSW 2000). | Import and supply | Prescription medicines | |
| AGRYLIN anagrelide hydrochloride 0.5 mg capsule bottle | Shire Australia Pty Limited | 71752 | CON-231 | The consent is effective from the 23 November 2017 until 31 October 2019. | 23/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The product labels do not bear the current sponsor’s address. | The labels to which this consent applies are those previously approved for the former address Level 6, 123 Epping Road, North Ryde NSW 2113. Arrangements are in place for the prompt referral of any queries or complaints concerning the products to the current address (Level 39, 225 George Street, Sydney NSW 2000). | Import and supply | Prescription medicines | |
| VYVANSE lisdexamfetamine dimesilate 70 mg capsule bottle | Shire Australia Pty Limited | 199228 | CON-231 | The consent is effective from the 23 November 2017 until 31 October 2019. | 23/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The product labels do not bear the current sponsor’s address. | The labels to which this consent applies are those previously approved for the former address Level 6, 123 Epping Road, North Ryde NSW 2113. Arrangements are in place for the prompt referral of any queries or complaints concerning the products to the current address (Level 39, 225 George Street, Sydney NSW 2000). | Import and supply | Prescription medicines | |
| VYVANSE lisdexamfetamine dimesilate 30 mg capsule bottle | Shire Australia Pty Limited | 199227 | CON-231 | The consent is effective from the 23 November 2017 until 31 October 2019. | 23/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The product labels do not bear the current sponsor’s address. | The labels to which this consent applies are those previously approved for the former address Level 6, 123 Epping Road, North Ryde NSW 2113. Arrangements are in place for the prompt referral of any queries or complaints concerning the products to the current address (Level 39, 225 George Street, Sydney NSW 2000). | Import and supply | Prescription medicines | |
| VYVANSE lisdexamfetamine dimesilate 50 mg capsule bottle | Shire Australia Pty Limited | 199226 | CON-231 | The consent is effective from the 23 November 2017 until 31 October 2019. | 23/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The product labels do not bear the current sponsor’s address. | The labels to which this consent applies are those previously approved for the former address Level 6, 123 Epping Road, North Ryde NSW 2113. Arrangements are in place for the prompt referral of any queries or complaints concerning the products to the current address (Level 39, 225 George Street, Sydney NSW 2000). | Import and supply | Prescription medicines | |
| VPRIV velaglucerase alfa (ghu) 400 Units powder for solution for infusion, glass vial | Shire Australia Pty Limited | 180965 | CON-231 | The consent is effective from the 23 November 2017 until 31 October 2019. | 23/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The product labels do not bear the current sponsor’s address. | The labels to which this consent applies are those previously approved for the former address Level 6, 123 Epping Road, North Ryde NSW 2113. Arrangements are in place for the prompt referral of any queries or complaints concerning the products to the current address (Level 39, 225 George Street, Sydney NSW 2000). | Import and supply | Prescription medicines | |
| CINRYZE C1 esterase inhibitor 500 units powder for solution for injection vial with diluent vial | Shire Australia Pty Limited | 177513 | CON-231 | The consent is effective from the 23 November 2017 until 31 October 2019. | 23/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The product labels do not bear the current sponsor’s address. | The labels to which this consent applies are those previously approved for the former address Level 6, 123 Epping Road, North Ryde NSW 2113. Arrangements are in place for the prompt referral of any queries or complaints concerning the products to the current address (Level 39, 225 George Street, Sydney NSW 2000). | Import and supply | Prescription medicines | |
| FIRAZYR icatibant (as acetate) 30 mg/3 mL injection pre-filled syringe | Shire Australia Pty Limited | 160313 | CON-231 | The consent is effective from the 23 November 2017 until 31 October 2019. | 23/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The product labels do not bear the current sponsor’s address. | The labels to which this consent applies are those previously approved for the former address Level 6, 123 Epping Road, North Ryde NSW 2113. Arrangements are in place for the prompt referral of any queries or complaints concerning the products to the current address (Level 39, 225 George Street, Sydney NSW 2000). | Import and supply | Prescription medicines | |
| MEZAVANT mesalazine 1.2 g gastro-resistant, prolonged release tablet blister pack | Shire Australia Pty Limited | 155172 | CON-231 | The consent is effective from the 23 November 2017 until 31 October 2019. | 23/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The product labels do not bear the current sponsor’s address. | The labels to which this consent applies are those previously approved for the former address Level 6, 123 Epping Road, North Ryde NSW 2113. Arrangements are in place for the prompt referral of any queries or complaints concerning the products to the current address (Level 39, 225 George Street, Sydney NSW 2000). | Import and supply | Prescription medicines | |
| FOSRENOL lanthanum 1000 mg (as lanthanum carbonate hydrate) chewable tablet bottle | Shire Australia Pty Limited | 106964 | CON-231 | The consent is effective from the 23 November 2017 until 31 October 2019. | 23/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The product labels do not bear the current sponsor’s address. | The labels to which this consent applies are those previously approved for the former address Level 6, 123 Epping Road, North Ryde NSW 2113. Arrangements are in place for the prompt referral of any queries or complaints concerning the products to the current address (Level 39, 225 George Street, Sydney NSW 2000). | Import and supply | Prescription medicines | |
| FOSRENOL lanthanum 750 mg (as lanthanum carbonate hydrate) chewable tablet bottle | Shire Australia Pty Limited | 106962 | CON-231 | The consent is effective from the 23 November 2017 until 31 October 2019. | 23/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The product labels do not bear the current sponsor’s address. | The labels to which this consent applies are those previously approved for the former address Level 6, 123 Epping Road, North Ryde NSW 2113. Arrangements are in place for the prompt referral of any queries or complaints concerning the products to the current address (Level 39, 225 George Street, Sydney NSW 2000). | Import and supply | Prescription medicines | |
| FOSRENOL lanthanum 500 mg (as lanthanum carbonate hydrate) chewable tablet bottle | Shire Australia Pty Limited | 106960 | CON-231 | The consent is effective from the 23 November 2017 until 31 October 2019. | 23/11/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The product labels do not bear the current sponsor’s address. | The labels to which this consent applies are those previously approved for the former address Level 6, 123 Epping Road, North Ryde NSW 2113. Arrangements are in place for the prompt referral of any queries or complaints concerning the products to the current address (Level 39, 225 George Street, Sydney NSW 2000). | Import and supply | Prescription medicines | |
| KALYDECO ivacaftor 75 mg granules sachet | Vertex Pharmaceuticals Australia Pty Ltd | 269661 | CON-230 | The consent is effective from the 23 November 2017 until 23 February 2018. | 23/11/2017 | Subclause 3(2)(l) and 3(12)(b) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines | The product carton, wallet and sachet labels do not bear the name or registered trademark of the Australian sponsor or supplier of the goods. | The labels (UK carton, wallet and sachet labels) will be over-stickered with the information in relation to the name and address of sponsor, ARTG number and statements 'Prescription Only Medicine' and 'Keep out of reach of children'. | Import and supply | Prescription medicines | |
| ENOXAPARIN WINTHROP enoxaparin sodium 100 mg/1 mL injection syringe | Sanofi–Aventis Australia Pty Ltd | 293891 | CON-232 | The consent is effective from the 28 November 2017 until further notice. | 28/11/2017 | Paragraph 10(5)(c) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines. | The letter height for the name of the medicine is not the correct height. | Import and supply | Prescription medicines | ||
| ENOXAPARIN WINTHROP enoxaparin sodium 80 mg/0.8 mL injection syringe | Sanofi–Aventis Australia Pty Ltd | 293890 | CON-232 | The consent is effective from the 28 November 2017 until further notice. | 28/11/2017 | Paragraph 10(5)(c) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines. | The letter height for the name of the medicine is not the correct height. | Import and supply | Prescription medicines | ||
| ENOXAPARIN WINTHROP enoxaparin sodium 60 mg/0.6 mL injection syringe | Sanofi–Aventis Australia Pty Ltd | 293889 | CON-232 | The consent is effective from the 28 November 2017 until further notice. | 28/11/2017 | Paragraph 10(5)(c) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines. | The letter height for the name of the medicine is not the correct height. | Import and supply | Prescription medicines | ||
| CREON MICRO pancreatic extract 20 g enteric coated granules bottle | Mylan Health Pty Ltd | 166118 | CON-233 | The consent is effective from the 11 December 2017 until further notice. | 11/12/2017 | Subections 9(1)(c), 9(3), 9(5) and/or 9(7) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | - The main label does not specify the quantity of the active ingredient in mg (as listed on the ARTG), although the quantity is clearly specified in Ph. Eur.units. - The name of the medicine and the active ingredient and quantity are not expressed as a cohesive unit on separate lines of text. - The active ingredient and quantity of the active ingredient is not displayed in a text height of not less than 3mm in height. | Labels to which this consent applies are those specified in the request submitted. | Supply | Prescription medicines | |
| CREON 40,000 pancreatic extract 400 mg capsules of enteric-coated minimicropsheres bottle | Mylan Health Pty Ltd | 158451 | CON-233 | The consent is effective from the 11 December 2017 until further notice. | 11/12/2017 | Subections 9(1)(c), 9(3), 9(5) and/or 9(7) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | - The main label does not specify the quantity of the active ingredient in mg (as listed on the ARTG), although the quantity is clearly specified in Ph. Eur.units. - The name of the medicine and the active ingredient and quantity are not expressed as a cohesive unit on separate lines of text. - The active ingredient and quantity of the active ingredient is not displayed in a text height of not less than 3mm in height. | Labels to which this consent applies are those specified in the request submitted. | Supply | Prescription medicines | |
| CREON 25,000 pancreatic extract 300 mg capsule bottle | Mylan Health Pty Ltd | 158452 | CON-233 | The consent is effective from the 11 December 2017 until further notice. | 11/12/2017 | Subections 9(1)(c), 9(3), 9(5) and/or 9(7) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | - The main label does not specify the quantity of the active ingredient in mg (as listed on the ARTG), although the quantity is clearly specified in Ph. Eur.units. - The name of the medicine and the active ingredient and quantity are not expressed as a cohesive unit on separate lines of text. - The active ingredient and quantity of the active ingredient is not displayed in a text height of not less than 3mm in height. | Labels to which this consent applies are those specified in the request submitted. | Supply | Prescription medicines | |
| CREON 10,000 capsule bottle (reformulation) | Mylan Health Pty Ltd | 158453 | CON-233 | The consent is effective from the 11 December 2017 until further notice. | 11/12/2017 | Subections 9(1)(c), 9(3), 9(5) and/or 9(7) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | - The main label does not specify the quantity of the active ingredient in mg (as listed on the ARTG), although the quantity is clearly specified in Ph. Eur.units. - The name of the medicine and the active ingredient and quantity are not expressed as a cohesive unit on separate lines of text. - The active ingredient and quantity of the active ingredient is not displayed in a text height of not less than 3mm in height. | Labels to which this consent applies are those specified in the request submitted. | Supply | Prescription medicines | |
| DILATREND carvedilol 25 mg tablet blister pack | Pharmaco Australia Ltd | 61108 | CON-234 | The consent is effective from the 14 December 2017 until 14 December 2018. | 14/12/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The product carton labels do not bear the current Australian sponsor’s name and address. | The labels to which this consent applies are those previously approved for Roche Products Pty Ltd. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Locked Bag 1009 GORDON NSW 2072). | Supply | Prescription medicines | |
| DILATREND carvedilol 12.5 mg tablet blister pack | Pharmaco Australia Ltd | 61107 | CON-234 | The consent is effective from the 14 December 2017 until 14 December 2018. | 14/12/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The product carton labels do not bear the current Australian sponsor’s name and address. | The labels to which this consent applies are those previously approved for Roche Products Pty Ltd. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Locked Bag 1009 GORDON NSW 2072). | Supply | Prescription medicines | |
| DILATREND carvedilol 6.25 mg tablet blister pack | Pharmaco Australia Ltd | 61106 | CON-234 | The consent is effective from the 14 December 2017 until 14 December 2018. | 14/12/2017 | Subclause 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for the labels for medicines | The product carton labels do not bear the current Australian sponsor’s name and address. | The labels to which this consent applies are those previously approved for Roche Products Pty Ltd. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Locked Bag 1009 GORDON NSW 2072). | Supply | Prescription medicines | |
| LATANOPROST SANDOZ latanoprost 50 micrograms/mL eye drop solution bottle | Sandoz Pty Ltd | 290733 | CON-235 | The consent is effective from the 15 December 2017 until 15 December 2019. | 15/12/2017 | Paragraphs 8(1)(f) and 8(1)(g) of the Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines. | The product eye drop bottle label batch and expiry details are not preceded by the appropriate prefixes. | A 'Dear Pharmacist' letter identical to that provided to the TGA on 14 December 2017 will be supplied to pharmacists instructing them to remind patients to keep the affected bottles in the correctly labelled outer cartons. | Import and supply | Prescription medicines | |
| WOMEN'S REGAINE minoxidil 5% w/w spray aerosol can | Johnson Johnson Pacific Pty Ltd | 240952 | CON-237 | The consent is effective from the 18 December 2017 until further notice. | 18/12/2017 | Paragraph 8(1)(j)(iv)(B) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines. | The medicine label declares the ethanol concentration as % w/w instead of % v/v. | Import and supply | Over-the-counter medicines | ||
| MEN'S REGAINE EXTRA STRENGTH FOAM (new formula) minoxidil 5% w/w aerosol can | Johnson Johnson Pacific Pty Ltd | 277919 | CON-237 | The consent is effective from the 18 December 2017 until further notice. | 18/12/2017 | Paragraph 8(1)(j)(iv)(B) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines. | The medicine label declares the ethanol concentration as % w/w instead of % v/v. | Import and supply | Over-the-counter medicines | ||
| TRUST COLD SORE CREAM aciclovir 5% cream tube | Pharmacor Pty Ltd | 205114 | W7130 | CON-236 | The consent is effective from the 18 December 2017 until 30 June 2018. | 18/12/2017 | Subclauses 3(2)(c) and 4(10) of Therapeutics Goods Order No. 69 - General requirements for labels for medicines. | In regards to the expression of the quantity of the active ingredient. The active ingredient has been incorrectly expressed as 5% instead of 5% w/w in both the primary and secondary packaging. | Supply | Over-the-counter medicines | |
| PULMICORT Respules budesonide 0.125 mg/mL nebuliser suspension | AstraZeneca Pty Ltd | 297787 | CON-239 | The consent is effective from 21 December 2017 until further notice. | 21/12/2017 | Does not conform to the requirements of the British Pharmacopoeia monograph Budesonide Nebuliser Suspension. | The product specification does not include all the tests required by this monograph. Specifically, the tests for related substances with regard to mobile phase, system suitability and limits were not carried out and the assay performed to determine the amount of product available at ‘shelf life’ stage is outside of the range specified in the British Pharmacopoeia monograph of 92.5 to 105.0% of the stated amount. | Export | Other therapeutic goods listed | ||
| PULMICORT Respules budesonide 0.5 mg/mL suspension for inhalation ampoule | AstraZeneca Pty Ltd | 297786 | CON-239 | The consent is effective from 21 December 2017 until further notice. | 21/12/2017 | Does not conform to the requirements of the British Pharmacopoeia monograph Budesonide Nebuliser Suspension. | The product specification does not include all the tests required by this monograph. Specifically, the tests for related substances with regard to mobile phase, system suitability and limits were not carried out and the assay performed to determine the amount of product available at ‘shelf life’ stage is outside of the range specified in the British Pharmacopoeia monograph of 92.5 to 105.0% of the stated amount. | Export | Other therapeutic goods listed | ||
| PULMICORT Respules budesonide 0.25 mg/mL suspension for inhalation ampoule | AstraZeneca Pty Ltd | 297785 | CON-239 | The consent is effective from 21 December 2017 until further notice. | 21/12/2017 | Does not conform to the requirements of the British Pharmacopoeia monograph Budesonide Nebuliser Suspension. | The product specification does not include all the tests required by this monograph. Specifically, the tests for related substances with regard to mobile phase, system suitability and limits were not carried out and the assay performed to determine the amount of product available at ‘shelf life’ stage is outside of the range specified in the British Pharmacopoeia monograph of 92.5 to 105.0% of the stated amount. | Export | Other therapeutic goods listed | ||
| PULMICORT Respules budesonide 0.125 mg/mL suspension for inhalation ampoule | AstraZeneca Pty Ltd | 297784 | CON-239 | The consent is effective from 21 December 2017 until further notice. | 21/12/2017 | Does not conform to the requirements of the British Pharmacopoeia monograph Budesonide Nebuliser Suspension. | The product specification does not include all the tests required by this monograph. Specifically, the tests for related substances with regard to mobile phase, system suitability and limits were not carried out and the assay performed to determine the amount of product available at ‘shelf life’ stage is outside of the range specified in the British Pharmacopoeia monograph of 92.5 to 105.0% of the stated amount. | Export | Other therapeutic goods listed | ||
| MENVEO meningococcal (Groups A, C, W-135 and Y) oligosaccharide CRM197 conjugate vaccine | GlaxoSmithKline Australia Pty Ltd | 192696 | CON-238 | The consent is effective from the 21 December 2017 until 31 December 2018. | 21/12/2017 | Subclauses 3(1)(b)(ii), 3(2)(e), 3(2)(g), 3(2)(n), 3(3), 3(2)(j), 3(2)(l), and 3(11)(c) of the Therapeutic Goods Order No. 69. | The product is supplied in Canadian packaging. | 1. GlaxoSmithKline puts in place communication and educational material as outlined in the application and in the email correspondence provided to Therapeutic Goods Administration on 14, 15, 18 and 19 December 2017 . 2. The batches supplied will only be provided to the Western Australian (WA) Government ACWY immunisation program and that the WA government has agreed to accept product labelled in Canadian packaging for this purpose. | Import and supply | Prescription medicines | |
| SOOTHERS berry flavour | Nestlé Australia Ltd | 295809 | CON-241 | The consent is effective from the 11 January 2018 until 30 May 2020. | 11/01/2018 | Paragraph 3(12)(a) for ‘individually wrapped goods’ of the Therapeutic Goods Order No. 69– General requirements for labels for medicines. | The product name, the names of the active ingredients or the quantities of the active ingredients in the goods do not appear on each individual unsealed wrapper. | The lozenges which are individually wrapped in an unsealed, protective cover are enclosed in a primary pack that includes the particulars referred to in sections 3(2) and 3(3) of the TGO 69. | Supply | Listed complementary medicines | |
| ASPEN PATENT BLUE V 50 mg/2 mL injection ampoule | Guerbet Australia Pty Ltd | 27539 | CON-245 | The consent is effective from the 12 January 2018 until 9 January 2019 | 12/01/2018 | Subclause 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines | The product labels do not display the name and contact details of the current sponsor in Australia. | 1. The sponsor has set-up re-direction of all mails addressed to Aspen Pharmacare Australia Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Aspen Pharmacare Australia and Guerbet Australia is in place to ensure all email and/or telephone contact inadvertently made to Aspen Pharmacare Australia regarding a product of Guerbet Australia is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| LIPIODOL ultra fluid iodised oil 10 mL injection BP ampoule | Guerbet Australia Pty Ltd | 34371 | CON-245 | The consent is effective from the 12 January 2018 until 9 January 2019 | 12/01/2018 | Subclause 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines | The product labels do not display the name and contact details of the current sponsor in Australia. | 1. The sponsor has set-up re-direction of all mails addressed to Aspen Pharmacare Australia Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Aspen Pharmacare Australia and Guerbet Australia is in place to ensure all email and/or telephone contact inadvertently made to Aspen Pharmacare Australia regarding a product of Guerbet Australia is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| DOTAREM gadoteric acid 279.32 mg/mL injection 20 mL pre-filled syringe | Guerbet Australia Pty Ltd | 160800 | CON-244 | The consent is effective from the 12 January 2018 until 30 November 2018. | 12/01/2018 | Subclause 7(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines 2017. | The product labels do not display the name and contact details of the current sponsor in Australia. | 1. The sponsor has set-up re-direction of all mails addressed to Apollo Imaging Solutions Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Apollo Imaging Solutions and Guerbet Australia Pty Ltd is in place to ensure all email and/or telephone contact made to Apollo Imaging Solutions regarding a product of Guerbet Australia is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| DOTAREM gadoteric acid 279.32 mg/mL injection 15 mL pre-filled syringe | Guerbet Australia Pty Ltd | 160799 | CON-244 | The consent is effective from the 12 January 2018 until 30 November 2018. | 12/01/2018 | Subclause 7(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines 2017. | The product labels do not display the name and contact details of the current sponsor in Australia. | 1. The sponsor has set-up re-direction of all mails addressed to Apollo Imaging Solutions Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Apollo Imaging Solutions and Guerbet Australia Pty Ltd is in place to ensure all email and/or telephone contact made to Apollo Imaging Solutions regarding a product of Guerbet Australia is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| DOTAREM gadoteric acid 279.32 mg/mL injection 10 mL pre-filled syringe | Guerbet Australia Pty Ltd | 160798 | CON-244 | The consent is effective from the 12 January 2018 until 30 November 2018. | 12/01/2018 | Subclause 7(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines 2017. | The product labels do not display the name and contact details of the current sponsor in Australia. | 1. The sponsor has set-up re-direction of all mails addressed to Apollo Imaging Solutions Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Apollo Imaging Solutions and Guerbet Australia Pty Ltd is in place to ensure all email and/or telephone contact made to Apollo Imaging Solutions regarding a product of Guerbet Australia is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| DOTAREM gadoteric acid 279.32 mg/mL injection 20 mL vial | Guerbet Australia Pty Ltd | 76923 | CON-244 | The consent is effective from the 12 January 2018 until 30 November 2018. | 12/01/2018 | Subclause 7(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines 2017. | The product labels do not display the name and contact details of the current sponsor in Australia. | 1. The sponsor has set-up re-direction of all mails addressed to Apollo Imaging Solutions Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Apollo Imaging Solutions and Guerbet Australia Pty Ltd is in place to ensure all email and/or telephone contact made to Apollo Imaging Solutions regarding a product of Guerbet Australia is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| DOTAREM gadoteric acid 279.32 mg/mL injection 15 mL vial | Guerbet Australia Pty Ltd | 76924 | CON-244 | The consent is effective from the 12 January 2018 until 30 November 2018. | 12/01/2018 | Subclause 7(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines 2017. | The product labels do not display the name and contact details of the current sponsor in Australia. | 1. The sponsor has set-up re-direction of all mails addressed to Apollo Imaging Solutions Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Apollo Imaging Solutions and Guerbet Australia Pty Ltd is in place to ensure all email and/or telephone contact made to Apollo Imaging Solutions regarding a product of Guerbet Australia is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| DOTAREM gadoteric acid 279.32 mg/mL injection 10 mL vial | Guerbet Australia Pty Ltd | 76925 | CON-244 | The consent is effective from the 12 January 2018 until 30 November 2018. | 12/01/2018 | Subclause 7(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines 2017. | The product labels do not display the name and contact details of the current sponsor in Australia. | 1. The sponsor has set-up re-direction of all mails addressed to Apollo Imaging Solutions Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Apollo Imaging Solutions and Guerbet Australia Pty Ltd is in place to ensure all email and/or telephone contact made to Apollo Imaging Solutions regarding a product of Guerbet Australia is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| DOTAREM gadoteric acid 279.32 mg/mL injection 5 mL vial | Guerbet Australia Pty Ltd | 76926 | CON-244 | The consent is effective from the 12 January 2018 until 30 November 2018. | 12/01/2018 | Subclause 7(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines 2017. | The product labels do not display the name and contact details of the current sponsor in Australia. | 1. The sponsor has set-up re-direction of all mails addressed to Apollo Imaging Solutions Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address. 2. An agreement between Apollo Imaging Solutions and Guerbet Australia Pty Ltd is in place to ensure all email and/or telephone contact made to Apollo Imaging Solutions regarding a product of Guerbet Australia is and will be redirected appropriately. | Import and supply | Prescription medicines | |
| ADVIL RAPID RELEASE ibuprofen sodium dihydrate 256 mg tablet bottle | Pfizer Australia | 288707 | W24301, W31815, W22477 | CON-242 | The consent is effective from the 17 January 2018 until 17 January 2020. | 17/01/2018 | Subclause 3(2)(h) of the Therapeutic Goods Order No. 69– General requirements for labels for medicines. | The bottle labels do not include the batch number prefix. | Import and supply | Over-the-counter medicines | |
| CABOMETYX cabozantinib (as (S)-malate) 60 mg film-coated tablet bottle | Ipsen Pty Ltd | 283799 | CON-243 | The consent is effective from the 22 January 2018 until 1 June 2018. | 22/01/2018 | Subclauses 3(2)(j) and 3(2)(l), of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels do not include the storage conditions, nor the name and address of the Australian sponsor or supplier. | 1. The tablets are otherwise the same as those registered; and 2. The tablets are labelled as detailed in the email from dr Whittaker on 30 November 2017; and 3. The carton is overstickered or otherwise marked with information identifying the Australian sponsor and the ARTG number on one panel. | Import and supply | Prescription medicines | |
| CABOMETYX cabozantinib (as (S)-malate) 40 mg film-coated tablet bottle | Ipsen Pty Ltd | 283801 | CON-243 | The consent is effective from the 22 January 2018 until 1 June 2018. | 22/01/2018 | Subclauses 3(2)(j) and 3(2)(l), of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels do not include the storage conditions, nor the name and address of the Australian sponsor or supplier. | 1. The tablets are otherwise the same as those registered; and 2. The tablets are labelled as detailed in the email from dr Whittaker on 30 November 2017; and 3. The carton is overstickered or otherwise marked with information identifying the Australian sponsor and the ARTG number on one panel. | Import and supply | Prescription medicines | |
| CABOMETYX cabozantinib (as (S)-malate) 20 mg film-coated tablet bottle | Ipsen Pty Ltd | 283800 | CON-243 | The consent is effective from the 22 January 2018 until 1 June 2018. | 22/01/2018 | Subclauses 3(2)(j) and 3(2)(l), of the Therapeutic Goods Order No. 69 General requirements for labels for medicines. | The labels do not include the storage conditions, nor the name and address of the Australian sponsor or supplier. | 1. The tablets are otherwise the same as those registered; and 2. The tablets are labelled as detailed in the email from dr Whittaker on 30 November 2017; and 3. The carton is overstickered or otherwise marked with information identifying the Australian sponsor and the ARTG number on one panel. | Import and supply | Prescription medicines | |
| Pandemic Influenza Vaccine H5N1 BAXTER (whole virion, vero cell derived, inactivated) suspension for injection 0.5 ml dose syringe | AU Pharma Pty Ltd | 204051 | CON-246 | The consent is effective from the 30 January 2018 until 30 January 2023. | 30/01/2018 | Subsections 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(c), 9(1)(e), 9(1)(f)(i), 9(3)(a), 9(3)(b), 9(5), 10(3)(a), 10(4)(c), 10(4), 10(4)(e) and 10(4)(j) of the Therapeutic Goods Order No. 91 (TGO 91) - Standard for labels of prescription and related medicines. | The products are proposed to be supplied with the European product labels, in a pandemic situation. | 1. This consent applies only to batches supplied in case of a pandemic situation. 2. A ‘Dear Healthcare Provider’ letter will be supplied with each affected batch and a copy of this letter will be provided to the Therpeutic Goods Administation (TGA) for review and approval, prior to release. 3. Australian patients and healthcare professionals will be advised of the appropriate contact details and use of the product, as outlined in the application form.4. Non-compliance with TGO 91 is limited to specifications detailed in the application form submitted to the TGA on 10 January 2018. | Import and supply | Prescription medicines | |
| Pandemic Influenza Vaccine H5N1 BAXTER (whole virion, vero cell derived, inactivated) suspension for injection 0.5 ml dose vial | AU Pharma Pty Ltd | 153381 | CON-246 | The consent is effective from the 30 January 2018 until 30 January 2023. | 30/01/2018 | Subsections 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(c), 9(1)(e), 9(1)(f)(i), 9(3)(a), 9(3)(b), 9(5), 10(3)(a), 10(4)(c), 10(4), 10(4)(e) and 10(4)(j) of the Therapeutic Goods Order No. 91 (TGO 91) - Standard for labels of prescription and related medicines. | The products are proposed to be supplied with the European product labels, in a pandemic situation. | 1. This consent applies only to batches supplied in case of a pandemic situation. 2. A ‘Dear Healthcare Provider’ letter will be supplied with each affected batch and a copy of this letter will be provided to the Therpeutic Goods Administation (TGA) for review and approval, prior to release. 3. Australian patients and healthcare professionals will be advised of the appropriate contact details and use of the product, as outlined in the application form.4. Non-compliance with TGO 91 is limited to specifications detailed in the application form submitted to the TGA on 10 January 2018. | Import and supply | Prescription medicines | |
| KETALAR ketamine 200 mg/2 mL (as hydrochloride) injection vial | Hospira Australia Pty Ltd | 70073 | CON-247 | The consent is effective from the 6 February 2018 until 30 April 2018. | 6/02/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines 2017. | The product carton labels do not bear the current Australian sponsor’s name and address. | A 'Dear Healthcare Provider' letter identical to that provided to the TGA in the correspondence dated 19 January 2018 will be supplied with each affected batch advising that as the ARTG product is out of stock, NZ stock has been used and the AUST R number and Australian sponsor details have been over stickered on these carton labels. | Supply | Prescription medicines | |
| Boundary Bend Wellness Olive Leaf Extract Solution Natural Flavour 4000 | Boundary Bend Ltd | 297141 | CON-249 | The consent is effective from 8 February 2018 until 8 February 2020. | 8/02/2018 | Section 8 of Therapeutic Goods Order No. 77 - Microbiological standards for medicines (TGO 77). | The product does not comply with the prescribed requirements of the British Pharmacopoeia (BP) preservative efficacy test acceptance criteria [Appendix XVI C, Criteria B (Table 5.1.3.3)] as mandated by section 8 of the TGO 77. The non-compliance is only applicable for the fungi Aspergillus brasiliensis where1 log reduction at 14 days was not observed with no increase at 28 days. | Supply | Listed complementary medicines | ||
| ACETEC 20 enalapril maleate 20 mg tablet blister pack | Alphapharm Pty Ltd | 75499 | CON-250 | The consent is effective from the 21 February 2018 until 21 February 2020. | 21/02/2018 | The British Pharmacopoeia monograph for Enalapril Tablets. | The content of the impurity ‘enalaprilat’ (aka Impurity C) must be NMT 1.5% w/w. As requested, the allowable limit for this impurity is NMT 2.0% w/w. | No other changes have been made to the product. | Supply | Prescription medicines | |
| ACETEC 10 enalapril maleate 10 mg tablet blister pack | Alphapharm Pty Ltd | 75498 | CON-250 | The consent is effective from the 21 February 2018 until 21 February 2020. | 21/02/2018 | The British Pharmacopoeia monograph for Enalapril Tablets. | The content of the impurity ‘enalaprilat’ (aka Impurity C) must be NMT 1.5% w/w. As requested, the allowable limit for this impurity is NMT 2.0% w/w. | No other changes have been made to the product. | Supply | Prescription medicines | |
| ACETEC 5 enalapril maleate 5 mg tablet blister pac | Alphapharm Pty Ltd | 75497 | CON-250 | The consent is effective from the 21 February 2018 until 21 February 2020. | 21/02/2018 | The British Pharmacopoeia monograph for Enalapril Tablets. | The content of the impurity ‘enalaprilat’ (aka Impurity C) must be NMT 1.5% w/w. As requested, the allowable limit for this impurity is NMT 2.0% w/w. | No other changes have been made to the product. | Supply | Prescription medicines | |
| ACETEC 2.5 enalapril maleate 2.5 mg tablet blister pack | Alphapharm Pty Ltd | 75457 | CON-250 | The consent is effective from the 21 February 2018 until 21 February 2020. | 21/02/2018 | The British Pharmacopoeia monograph for Enalapril Tablets. | The content of the impurity ‘enalaprilat’ (aka Impurity C) must be NMT 1.5% w/w. As requested, the allowable limit for this impurity is NMT 2.0% w/w. | No other changes have been made to the product. | Supply | Prescription medicines | |
| Swisse Ultiboost Super Strength Deep Sea Krill Oil | Swisse Wellness Pty Ltd | 292915 | CON-240 | The consent is effective from the 21 February 2017 until 31 January 2019. | 21/02/2018 | The United States Pharmacopeia-National Formulary (USP40-NF35) monograph for Krill Oil. | Non-compliance with The United States Pharmacopeia-National Formulary (USP40-NF35) monograph for Krill Oil, the default standard for Krill Oil in Australia. The raw material complies with the USP40-NF35 monograph, with the exception of%2358; 1. The concentrations of the fatty acids myristic acid (C14%2358;0), oleic acid (C18%2358;1 n-9), and eicosapentoenoic acid (C20%2358;5 n-3) in the acceptance criteria for ‘Identification Test A-Fatty Acid Profile’ 2. The ratio between palmitic acid (C16%2358;0) and myristic acid (C14%2358;0) in the acceptance criteria for ‘Identification Test A-Fatty Acid Profile’ 3. The acceptance criteria ‘Content of Astaxanthin’ | That the raw material meets the limits as set out in the table below%2358;Imposed limits for exempt Krill oil%2358; Test Limits 1. Identification Test A-Fatty Acid Profile Myristic acid 5.0-13.0% Oleic acid 6.0-14.5% Eicosapentoenoic acid 14.0-28.0% Ratio between palmitic and myristic acids 1.6-3.6% 2. Content of Astaxanthin NLT 0.005% NLT = Not less than The raw material in relation to which the consent is given must comply with all other applicable parts of the USP40-NF35 and all other applicable standards. | Import, supply and export | Listed complementary medicines | |
| Swisse Ultiboost High Strength Deep Sea Krill Oil | Swisse Wellness Pty Ltd | 292914 | CON-240 | The consent is effective from the 21 February 2017 until 31 January 2019. | 21/02/2018 | The United States Pharmacopeia-National Formulary (USP40-NF35) monograph for Krill Oil. | Non-compliance with The United States Pharmacopeia-National Formulary (USP40-NF35) monograph for Krill Oil, the default standard for Krill Oil in Australia. The raw material complies with the USP40-NF35 monograph, with the exception of%2358; 1. The concentrations of the fatty acids myristic acid (C14%2358;0), oleic acid (C18%2358;1 n-9), and eicosapentoenoic acid (C20%2358;5 n-3) in the acceptance criteria for ‘Identification Test A-Fatty Acid Profile’ 2. The ratio between palmitic acid (C16%2358;0) and myristic acid (C14%2358;0) in the acceptance criteria for ‘Identification Test A-Fatty Acid Profile’ 3. The acceptance criteria ‘Content of Astaxanthin’ | That the raw material meets the limits as set out in the table below%2358;Imposed limits for exempt Krill oil%2358; Test Limits 1. Identification Test A-Fatty Acid Profile Myristic acid 5.0-13.0% Oleic acid 6.0-14.5% Eicosapentoenoic acid 14.0-28.0% Ratio between palmitic and myristic acids 1.6-3.6% 2. Content of Astaxanthin NLT 0.005% NLT = Not less than The raw material in relation to which the consent is given must comply with all other applicable parts of the USP40-NF35 and all other applicable standards. | Import, supply and export | Listed complementary medicines | |
| Swisse Ultiboost Deep Sea Krill Oil | Swisse Wellness Pty Ltd | 292919 | CON-240 | The consent is effective from the 21 February 2017 until 31 January 2019. | 21/02/2018 | The United States Pharmacopeia-National Formulary (USP40-NF35) monograph for Krill Oil. | Non-compliance with The United States Pharmacopeia-National Formulary (USP40-NF35) monograph for Krill Oil, the default standard for Krill Oil in Australia. The raw material complies with the USP40-NF35 monograph, with the exception of%2358; 1. The concentrations of the fatty acids myristic acid (C14%2358;0), oleic acid (C18%2358;1 n-9), and eicosapentoenoic acid (C20%2358;5 n-3) in the acceptance criteria for ‘Identification Test A-Fatty Acid Profile’ 2. The ratio between palmitic acid (C16%2358;0) and myristic acid (C14%2358;0) in the acceptance criteria for ‘Identification Test A-Fatty Acid Profile’ 3. The acceptance criteria ‘Content of Astaxanthin’ | That the raw material meets the limits as set out in the table below%2358;Imposed limits for exempt Krill oil%2358; Test Limits 1. Identification Test A-Fatty Acid Profile Myristic acid 5.0-13.0% Oleic acid 6.0-14.5% Eicosapentoenoic acid 14.0-28.0% Ratio between palmitic and myristic acids 1.6-3.6% 2. Content of Astaxanthin NLT 0.005% NLT = Not less than The raw material in relation to which the consent is given must comply with all other applicable parts of the USP40-NF35 and all other applicable standards. | Import, supply and export | Listed complementary medicines | |
| ACETYLCYSTEINE-LINK INJECTION acetylcysteine 2 g/10 mL concentrated injection ampoule | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | 170803 | 70707 | CON-251 | The consent is effective from 2 March 2018 until 2 July 2018. | 2/03/2018 | Therapeutic Goods Order No.69 - General requirements for labels for medicines 2017 (TGO 69), paragraphs 7(2)(a), 7(2)(j), 7(5)(b)(i), 7(5)(b)(ii) and subsection 7(11). | The UK carton and ampoule labels%2358;•Do not bear the Australian product name (paragraph 7(2)(a)).•Do not bear the registered storage condition (paragraph 7(2)(j)) •The UK carton label does not express the quantity of each excipient in the medicine (paragraph 7(5)(b)(i)).•The UK carton label does not bear the statements ‘Use in one patient on one occasion only. Contains no antimicrobial preservative’ (paragraph 7(5)(b)(ii)).•The ampoule label does not bear the correct sponsor name or registered trade mark (subsection 7(11)). | 1. Dear Healthcare Professional letter identical to that provided to the Therapeutic Goods Administration with the letter of application dated 15 February 2018 will be supplied to all affected customers that the UK product will be supplied and referring the Healthcare Professionals to the Australia PI rather than the UK packaging insert supplied with the UK product.2. The UK carton and ampoule labels to which this consent applies are those provided with the letter of application, where the carton will be over-stickered with details of the Australian sponsor name and contact details (address, phone, fax and email), and the AUST R number. | Import and supply | Prescription medicines |
| ZYVOX linezolid 600 mg/300 mL injection infusion bag | Pfizer Australia Pty Ltd | 79690 | CON-253 | The consent is effective from the 8 March 2018 until 1 July 2019. | 8/03/2018 | Parapgrahs 7(2)(a), 7(2)(c), 7(2)(e), 7(2)(j), 7(2)(l), 7(6)(c), 7(6)(d), 7(6)(h), 7(6)(i), 7(6)(j) and 7(6)(k) of the Therapeutic Goods Order No.69 – General requirements for labels for medicines 2017 (TGO 69) | The European and Middle Eastern flexibag and aluminium overwrap labels do not comply with the labelling requirements stipulated in the TGO 69 for the following reasons%2358; Paragraph 7(2)(a) – Does not bear the Australian product name Paragraph 7(2)(c) – Does not express the quantity of the active ingredient as required Paragraph 7(2)(e) - Does not bear the correct name of the dosage form Paragraph 7(2)(j) - Does not bear the registered storage conditions Paragraph 7(2)(l) –Does not bear the name and address of the sponsor Paragraph 7(6)(c) – The product name does not include a statement of the proportion of that active ingredient expressed in terms of weight in the stated volume of injection in the container Paragraph 7(6)(d) – Does not bear the quantities of all excipients in the stated volume of injection in the container. Paragraph 7(6)(h), (i) and (j) – Does not bear a statement specifying the isotonicity, pH and osmolality. Paragraph 7(6)(k) – Does not bear the words, quot;single usequot; or quot;single dosequot; | 1. A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 6 March 2018 will be supplied with each affected batch advising that the ARTG product is out of stock and to disregard the pack insert and refer to the Australian PI.2. The carton labels will be over-stickered with the Australian approved labels at a GMP certified facility. | Import and supply | Prescription medicines | |
| HEPATOLITE kit for production of Technetium(99mTc) disofenin powder for injection multidose vial | Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific | 19146 | 230057 | CON-255 | The consent is effective from the 12 April 2018 until 30 June 2018. | 12/04/2018 | Section 11 of Therapeutic Goods Order No. 69 - General Requirements for Labels for Medicines 2017 (TGO 69). | The storage condition is not described as permitted by section 11 of TGO 69. | 1. A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration with the application letter, stating the differences between the US and Australian-registered products, and that the Australian approved storage conditions should continue to be applied, is provided with each batch. 2. A copy of the Australian package insert will be supplied. 3. The carton labels are those used for the USA market and will be over-stickered with the Australian sponsor and AUST R number. | Import and supply | Prescription medicines |
| Gliolan (aminolevulinic acid HCl) Powder for Oral Solution, 30 mg/mL, vial | Specialised Therapeutics Glio Pty Ltd | 202549 | CON-256 | The consent is effective from 19 April 2018 until 19 October 2018. | 19/04/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines 2017. | The goods do not state the current sponsor name. | 1. The labels to which this consent applies are those previously approved for the former sponsor 'Specialised Therapeutics Australia Pty Ltd'. Arrangements are in place with the former sponsor 'Specialised Therapeutics Australia Pty Ltd' for the prompt referral of any queries or complaints concerning the products to the current sponsor 'Specialised Therapeutics Glio Pty Ltd'. 2. Arrangements are also in place for the prompt referral of any queries or complaints concerning the products to the current sponsor ‘Specialised Therapeutics Glio Pty Ltd’, once the former sponsor relocate to a different address in July 2018. | Import and supply | Prescription medicines | |
| NYAL ANTIVIRAL COLD SORE cream aciclovir 50 mg/g tube | iNova Pharmaceuticals (Australia) Pty Ltd | 147218 | CON-257 | The consent is effective from 2 May 2018 until 30 April 2019. | 2/05/2018 | Section 8 of the Therapeutic Goods Order No. 77 – Microbiological Standards for Medicines. | The product does not comply with the acceptance criteria specified in the British Pharmacopoeia Test for Efficacy of Antimicrobial Preservation for Aspergillus brasiliensis. | The product must meet the acceptance criteria for Aspergillus brasiliensis specified in the USP General Chapter lt;51gt; Antimicrobial Effectiveness Testing. | Supply | Over-the-counter medicines | |
| Elevit | Bayer Australia Ltd | 213113 | CM 56061, CM56066, CM56062, CM56168, CM56169, CM56284 | CON-258 | The consent is effective from 11 May 2018 until 11 May 2020. | 11/05/2018 | Subsection 11(b) of Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules (TGO 78). | 6 batches of the product do not comply with the current acceptance criteria for average assay content of iodine (as potassium iodate) of 198-253 µg/tab (90.0% to 115.0% of label claim). | The content of iodine must not be less than 90.0 percent and not more than 140.0 percent of the stated content on the label. | Import and supply | Registered complementary medicines |
| GO Krill Oil 1,500 mg 1-A-Day Odourless | The Better Health Company (Australia) PTY | 292074 | CON-260 | The consent is effective from 17 May 2018 until 1 December 2018. | 17/05/2018 | The United States Pharmacopeia-National Formulary (USP41-NF36) monograph for Krill Oil, the default standard for Krill Oil in Australia. | The content of palmitoleic acid exceeds the upper specification level by 0.16%. (Current USP41-NF36 specifications for palmitoleic acid are 2.5% to 9.0%). | 1. The content of palmitoleic to be within the specifications of 2.5% to 12.0%. 2. The raw material in relation to which the consent is given must comply with all other applicable parts of the USP41-NF36 and all other applicable standards. | Import and supply | Listed complementary medicines | |
| GO Krill Oil 750 mg Odourless | The Better Health Company (Australia) PTY | 292073 | CON-260 | The consent is effective from 17 May 2018 until 1 December 2018. | 17/05/2018 | The United States Pharmacopeia-National Formulary (USP41-NF36) monograph for Krill Oil, the default standard for Krill Oil in Australia. | The content of palmitoleic acid exceeds the upper specification level by 0.16%. (Current USP41-NF36 specifications for palmitoleic acid are 2.5% to 9.0%). | 1. The content of palmitoleic to be within the specifications of 2.5% to 12.0%. 2. The raw material in relation to which the consent is given must comply with all other applicable parts of the USP41-NF36 and all other applicable standards. | Import and supply | Listed complementary medicines | |
| CYCLONEX cyclophosphamide 50mg (anhydrous) tablet blister pack | The SPD Company Pty Ltd | 297901 | •Batch number 17001A •Batch number 17002A •Batch number 17003A | CON-300 | The consent is effective from 18 May 2018 until the end of batches | 18/05/2018 | Therapeutic Goods Order No. 78 Standard for tablets and capsules - British Pharmacopoeia monograph for cyclophosphamide tablets | The product does not comply with assay limits in the British Pharmacopoeia monograph (92.5-107.5%). | The batches mustcomply with the USP monograph limits for Assay (90.0-110.0%). This decision is also extended to a further six subsequently manufactured batches, for which batch numbers are not yet assigned. It is expected that records of these numbers will be kept and related back to this consent. | Supply | Prescription medicines |
| ALENDRONATE PLUS D3 CALCIUM ACTAVIS alendronic acid (as sodium) 70 mg and colecalciferol 140 microgram tablet and calcium 500 mg tablet composite pack | Dr Reddy's Laboratories (Australia) Pty Ltd | 222686 | CON-261 | The consent is effective from 18 May 2018 until the 18 May 2020. | 18/05/2018 | Subsection 11(b) of the Therapeutic Goods Order 78 - Standard for Tablets and Capsules (TGO 78). | The products do not meet the expiry assay limits of 92.5% - 107.5 % for the stated content of colecalciferol. | The expiry colecalciferol assay limits for the products are 90.0% - 110.0%. | Import and supply | Prescription medicines | |
| ALENDRONATE PLUS D3 CAL alendronic acid (as sodium) 70 mg and colecalciferol 140 microgram tablet and calcium 500 mg tablet composite pack | Dr Reddy's Laboratories (Australia) Pty Ltd | 222685 | CON-261 | The consent is effective from 18 May 2018 until the 18 May 2020. | 18/05/2018 | Subsection 11(b) of the Therapeutic Goods Order 78 - Standard for Tablets and Capsules (TGO 78). | The products do not meet the expiry assay limits of 92.5% - 107.5 % for the stated content of colecalciferol. | The expiry colecalciferol assay limits for the products are 90.0% - 110.0%. | Import and supply | Prescription medicines | |
| ALENDRONATE PLUS D3 and CALCIUM SANDOZ alendronic acid (as sodium) 70 mg and colecalciferol 140 ug tablet and calcium 500 mg tablet composite pack | Dr Reddy's Laboratories (Australia) Pty Ltd | 222684 | CON-261 | The consent is effective from 18 May 2018 until the 18 May 2020. | 18/05/2018 | Subsection 11(b) of the Therapeutic Goods Order 78 - Standard for Tablets and Capsules (TGO 78). | The products do not meet the expiry assay limits of 92.5% - 107.5 % for the stated content of colecalciferol. | The expiry colecalciferol assay limits for the products are 90.0% - 110.0%. | Import and supply | Prescription medicines | |
| ALENDROBELL PLUS D3 and CALCIUM alendronic acid (as sodium) 70 mg and colecalciferol 140 microgram tablet and calcium 500 mg tablet composite pack | Dr Reddy's Laboratories (Australia) Pty Ltd | 222683 | CON-261 | The consent is effective from 18 May 2018 until the 18 May 2020. | 18/05/2018 | Subsection 11(b) of the Therapeutic Goods Order 78 - Standard for Tablets and Capsules (TGO 78). | The products do not meet the expiry assay limits of 92.5% - 107.5 % for the stated content of colecalciferol. | The expiry colecalciferol assay limits for the products are 90.0% - 110.0%. | Import and supply | Prescription medicines | |
| REDDYMAX PLUS D-CAL alendronic acid (as sodium) 70 mg and colecalciferol 140 microgram tablet and calcium 500 mg tablet composite pack | Dr Reddy's Laboratories (Australia) Pty Ltd | 222679 | CON-261 | The consent is effective from 18 May 2018 until the 18 May 2020. | 18/05/2018 | Subsection 11(b) of the Therapeutic Goods Order 78 - Standard for Tablets and Capsules (TGO 78). | The products do not meet the expiry assay limits of 92.5% - 107.5 % for the stated content of colecalciferol. | The expiry colecalciferol assay limits for the products are 90.0% - 110.0%. | Import and supply | Prescription medicines | |
| ALENDROBELL PLUS D3 70 mg/140 microgram alendronate (as sodium) 70 mg and colecalciferol 140 microgram tablet blister pack | Dr Reddy's Laboratories (Australia) Pty Ltd | 206938 | CON-261 | The consent is effective from 18 May 2018 until the 18 May 2020. | 18/05/2018 | Subsection 11(b) of the Therapeutic Goods Order 78 - Standard for Tablets and Capsules (TGO 78). | The products do not meet the expiry assay limits of 92.5% - 107.5 % for the stated content of colecalciferol. | The expiry colecalciferol assay limits for the products are 90.0% - 110.0%. | Import and supply | Prescription medicines | |
| FONATPLUS 70 mg/70 ug alendronate (as sodium) and colecalciferol 70 mg/70 microgram (2800 IU) tablet blister pack | Dr Reddy's Laboratories (Australia) Pty Ltd | 206937 | CON-261 | The consent is effective from 18 May 2018 until the 18 May 2020. | 18/05/2018 | Subsection 11(b) of the Therapeutic Goods Order 78 - Standard for Tablets and Capsules (TGO 78). | The products do not meet the expiry assay limits of 92.5% - 107.5 % for the stated content of colecalciferol. | The expiry colecalciferol assay limits for the products are 90.0% - 110.0%. | Import and supply | Prescription medicines | |
| ALENDRONATE PLUS D3 - DRLA 70 mg/140 microgram alendronate (as sodium) and colecalciferol 140 microgram (5600 IU) tablet blister pack | Dr Reddy's Laboratories (Australia) Pty Ltd | 206936 | CON-261 | The consent is effective from 18 May 2018 until the 18 May 2020. | 18/05/2018 | Subsection 11(b) of the Therapeutic Goods Order 78 - Standard for Tablets and Capsules (TGO 78). | The products do not meet the expiry assay limits of 92.5% - 107.5 % for the stated content of colecalciferol. | The expiry colecalciferol assay limits for the products are 90.0% - 110.0%. | Import and supply | Prescription medicines | |
| ALENDRONATE PLUS D3 SANDOZ 70 mg/140 microgram alendronate (as sodium) 70 mg and colecalciferol 140 microgram (5600 IU) tablet blister pack | Dr Reddy's Laboratories (Australia) Pty Ltd | 206935 | CON-261 | The consent is effective from 18 May 2018 until the 18 May 2020. | 18/05/2018 | Subsection 11(b) of the Therapeutic Goods Order 78 - Standard for Tablets and Capsules (TGO 78). | The products do not meet the expiry assay limits of 92.5% - 107.5 % for the stated content of colecalciferol. | The expiry colecalciferol assay limits for the products are 90.0% - 110.0%. | Import and supply | Prescription medicines | |
| ALENDROBELL PLUS D3 70 mg/70 microgram alendronate (as sodium) 70 mg and colecalciferol 70 microgram tablet blister pack | Dr Reddy's Laboratories (Australia) Pty Ltd | 206934 | CON-261 | The consent is effective from 18 May 2018 until the 18 May 2020. | 18/05/2018 | Subsection 11(b) of the Therapeutic Goods Order 78 - Standard for Tablets and Capsules (TGO 78). | The products do not meet the expiry assay limits of 92.5% - 107.5 % for the stated content of colecalciferol. | The expiry colecalciferol assay limits for the products are 90.0% - 110.0%. | Import and supply | Prescription medicines | |
| FONATPLUS 70 mg/140 ug alendronate (as sodium) 70 mg and colecalciferol 140 microgram (5600 IU) tablet blister pack | Dr Reddy's Laboratories (Australia) Pty Ltd | 206931 | CON-261 | The consent is effective from 18 May 2018 until the 18 May 2020. | 18/05/2018 | Subsection 11(b) of the Therapeutic Goods Order 78 - Standard for Tablets and Capsules (TGO 78). | The products do not meet the expiry assay limits of 92.5% - 107.5 % for the stated content of colecalciferol. | The expiry colecalciferol assay limits for the products are 90.0% - 110.0%. | Import and supply | Prescription medicines | |
| ALENDRONATE PLUS D3 - DRLA 70 mg/70 microgram alendronate (as sodium) and colecalciferol 70 microgram (2800 IU) tablet blister pack | Dr Reddy's Laboratories (Australia) Pty Ltd | 206930 | CON-261 | The consent is effective from 18 May 2018 until the 18 May 2020. | 18/05/2018 | Subsection 11(b) of the Therapeutic Goods Order 78 - Standard for Tablets and Capsules (TGO 78). | The products do not meet the expiry assay limits of 92.5% - 107.5 % for the stated content of colecalciferol. | The expiry colecalciferol assay limits for the products are 90.0% - 110.0%. | Import and supply | Prescription medicines | |
| ALENDRONATE PLUS D3 SANDOZ 70 mg/70 microgram alendronate (as sodium) and colecalciferol 70 mg/70 microgram (2800 IU) tablet blister pack | Dr Reddy's Laboratories (Australia) Pty Ltd | 206929 | CON-261 | The consent is effective from 18 May 2018 until the 18 May 2020. | 18/05/2018 | Subsection 11(b) of the Therapeutic Goods Order 78 - Standard for Tablets and Capsules (TGO 78). | The products do not meet the expiry assay limits of 92.5% - 107.5 % for the stated content of colecalciferol. | The expiry colecalciferol assay limits for the products are 90.0% - 110.0%. | Import and supply | Prescription medicines | |
| EUCERIN wool alcohols 60 mg/g ointment jar | Beiersdorf Health Care Australia Pty Ltd | 34155 | CON-248 | The consent is effective from the 22 May 2018 until 31 January 2021 | 22/05/2018 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – – General Requirements for Labels for Medicines 2017. | The labels do not include the correct name of the sponsor or supplier of the products. | The labels to which this consent applies are those previously approved for the former sponsor Beiersdorf Australia Limited, and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to the current sponsor, Beiersdorf Health Care Australia Pty Ltd. | Supply | Over-the-counter medicines | |
| EUCERIN wool alcohols 60 mg/g ointment tube | Beiersdorf Health Care Australia Pty Ltd | 34154 | CON-248 | The consent is effective from the 22 May 2018 until 31 January 2021 | 22/05/2018 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – – General Requirements for Labels for Medicines 2017. | The labels do not include the correct name of the sponsor or supplier of the products. | The labels to which this consent applies are those previously approved for the former sponsor Beiersdorf Australia Limited, and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to the current sponsor, Beiersdorf Health Care Australia Pty Ltd. | Supply | Over-the-counter medicines | |
| FluQuadri Inactivated Quadrivalent Influenza Vaccine (Split Virion), Influenza virus haemagglutinin 60 mcg, 0.5 mL suspension for injection | Sanofi Aventis Australia Pty Ltd | 213963 | UI942AC | CON-262 | The consent is effective from 24 May 2018 until 28 February 2019. | 24/05/2018 | European Pharmacopeia (01/2008:0158) test for Bacterial Endotoxins (2.6.14) and the assay of Haemagglutinin Antigen by an immunodiffusion test (2.7.1) and Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91). | 1. European Pharmacopeia (01/2008%2358;0158) the test for Bacterial Endotoxins (2.6.14) and the assay of Haemagglutinin Antigen by an immunodiffusion test (2.7.1), are performed on the Final Bulk Product only and not performed on the Final Lot. 2. Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO91)” The batch is packaged in the Standard Export labelling (in Spanish and English), which does not conform with the requirements of the TGO 91 on the following%2358; Paragraph 8(1)(d) the name of the dosage form (missing on carton) Paragraph 8(1)(i) the name and contact details of the sponsor (missing on carton) Paragraph 8(1)(j)(iv)(A) indicating that the medicine contains the substance expressed using the Name stated in Column 4 of Schedule 1 (statement regarding manufactured in eggs missing on carton) Paragraph 9(1)(b) the name(s) of all active ingredients in the medicine (missing on syringe) Paragraph 9(1)(c) the quantity or proportion of all active ingredients in the medicine (missing on syringe) Paragraph 9(3) the name of the medicine and the name of active ingredients on the main label (they are placed separately as the same texts in Spanish are placed before English texts) Paragraph 10(5)(c) the name of the medicine is displayed in a text size of not less than 1.5 millimetres (the trade name quot;FluQuadriquot; is less than 1.5 mm on syringe) Paragraph 11(1)(a) use of appropriate metric units (the abbreviation quot;mcgquot; is used rather than quot;microgramquot; in full on carton) Subsection 11(5) permitted statements of storage temperature conditions (quot;Store between +2oC to +8oC. Do not freezequot; is used rather than quot;Store at 2oC to 8oCquot; (Refrigerate. Do not freeze) on carton). | 1. This consent applies only to the FluQuadri batch UI942AC. 2. A 'Dear Healthcare Professional' letter identical to that provided to the TGA on 21 May 2018 will be supplied with the affected batch. 3. Non”compliance with the European Pharmacopoeia is limited to the tests detailed in the application submitted to the TGA on 18 May 2018. 4. Non”compliance with the TGO 91 is limited to specifications detailed in the application form submitted to the TGA on 18 May 2018. | Import and supply | Prescription medicines |
| PROQUAD measles mumps rubella varicella live virus vaccine injection vial with prefilled diluent syringe | Merck Sharp and Dohme (Australia) Pty Limited | 126157 | R011831 and R011832 | CON-265 | The consent is effective from 25 May 2018 until 25 October 2019. | 25/05/2018 | Section 7(2)(a) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91). | The newly implemented double detachable labels for the vaccine vial are obscuring some of the information on the vial label as follows%2358; the name of the medicine the name of the active ingredients in the medicine the name of the dosage form the quantity of the medicine the approved route of administration | 1. This consent applies only to PROQUAD measles mumps rubella varicella live virus vaccine injection vial with prefilled diluent syringe [AUST R 126157], batch R011831 (expiry 25 October 2019, quantity%2358; 27,394) and R011832 (expiry 25 October 2019, quantity%2358; 5,686); 2. Non-compliance with the TGO 91 is limited to the information detailed in the submission; 3. A 'Dear Healthcare Professional' letter identical to that provided to the TGA on 18 May 2018 will be supplied with each affected batch warning that some of the text including the trade name on the main label is obscured and upon removal of the detachable labels, the text on the main label is fully visible; 4. The distributor for the labels to which this consent applies is Seqirus and arrangements are in place with the distributor Seqirus' Medical Information Department on 1800 642 865 for the prompt referral of any queries or complaints concerning the product. | Import and supply | Prescription medicines |
| M-M-R II powder for injection vial with pre-filled diluent syringe, single dose | Merck Sharp and Dohme (Australia) Pty Limited | 201877 | R011834 | CON-264 | The consent is effective from 25 May 2018 until 23 February 2020. | 25/05/2018 | Section 7(2)(a) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91). | The newly implemented double detachable labels for the vaccine vial are obscuring some of the information on the vial label as follows%2358; the name of the medicine the name of the active ingredients in the medicine the name of the dosage form the quantity of the medicine the approved route of administration | 1.This consent applies only to M-M-R II powder for injection vial with pre-filled diluent syringe, single dose (AUST R 201877), batch R011834 (expiry 23 February 2020, quantity%2358; 50,400). 2. Non-compliance with the TGO 91 is limited to the information detailed in the submission. 3. A 'Dear Healthcare Professional' letter identical to that provided to the TGA on 18 May 2018 will be supplied with each affected batch warning that some of the text including the trade name on the main label is obscured and upon removal of the detachable labels, the text on the main label is fully visible. 4. The distributor for the labels to which this consent applies is Seqirus and arrangements are in place with the distributor Seqirus' Medical Information Department on 1800 642 865 for the prompt referral of any queries or complaints concerning the product. | Import and supply | Prescription medicines |
| VALACICLOVIR SZ valaciclovir (as hydrochloride) 500 mg film-coated tablet blister pack | Sandoz Pty Ltd | 154460 | CON-263 | The consent is effective from 25 May 2018 until 31 July 2018. | 25/05/2018 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO No. 69). | The labels of the products do not contain the current company address. | 1. The labels of the products to which this consent applies are those previously approved and contain the previous company address as detailed in the application. 2. Company contact details remain unchanged and arrangements are in place for the prompt re-direction of mails and correspondence to the new company address. | Import and supply | Prescription medicines | |
| Blood components | Australian Red Cross Blood Service | N/A | CON-271 | The consent is effective from 29 May 2018 until the conditions no longer remain true. | 29/05/2018 | Therapeutic Goods Order 81 - Standards for Blood and Blood Components - Council of Europe Guide to the preparation, use and quality assurance of blood components (14th edition) (CoE Guide) | To accept donors who have ever injected, or been injected with, any drug for a non-medical reason following a deferral of 5 years from the date of the last injection. | A minimum deferral period of 5 years is applied to blood donors who have ever injected, or been injected with, any drug for a non-medical reason from the date of the last injection. | Supply | Blood, tissues, and biologicals | |
| AUSGEM gemfibrozil 600 mg tablet bottle | Arrow Pharma Pty Ltd | 62099 | 7230543 | CON-266 | The consent is effective from 29 May 2018 until the end of the supply of batch 7230543. | 29/05/2018 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines. | The labels of the products do not contain the current sponsor name and contact details. | The labels of the products to which this consent applies are those previously approved and contain the previous sponsor Aspen Pharma Pty Ltd and arrangements are in place with the former sponsor Aspen Pharma for the prompt referral of any queries or complaints concerning the products to Arrow Pharma Pty Ltd. | Import and supply | Prescription medicines |
| FluQuadri Inactivated Quadrivalent Influenza Vaccine (Split Virion), Influenza virus haemagglutinin 60 mcg, 0.5 mL suspension for injection | Sanofi Aventis Australia Pty Ltd | 213963 | UI946AA | CON-268 | The consent is effective from 4 June 2018 until 28 February 2019 | 4/06/2018 | 1. European Pharmacopeia (01/2008:0158) 2. Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | 1. Passage of the working seed lots UC4216- 13 (A/Michigan/45/2015 X-275), UC4105-30 (B/Brisbane/60/2008) and UC4184-14 (B/Phuket/3073/2013); neuraminidase tests are not performed on the first 3 monovalent bulk lots manufactured from each of the above working seed lots; test for Bacterial Endotoxins (2.6.14) and the assay of Haemagglutinin Antigen by an immunodiffusion test (2.7.1) are not performed on the Final Lot. 2. The batch is packaged in the Standard Export labelling (in Spanish and English), which does not conform with the requirements of the TGO 91 on the following%2358; Paragraph 8(1)(d) the name of the dosage form (missing on carton) Paragraph 8(1)(i) the name and contact details of the sponsor (missing on carton) Paragraph 8(1)(j)(iv)(A) indicating that the medicine contains the substance expressed using the Name stated in Column 4 of Schedule 1 (statement regarding manufactured in eggs missing on carton) Paragraph 9(1)(b) the name(s) of all active ingredients in the medicine (missing on syringe) Paragraph 9(1)(c) the quantity or proportion of all active ingredients in the medicine (missing on syringe) Subsection 9(3) the name of the medicine and the name of active ingredients on the main label (they are placed separately as the same texts in Spanish are placed before English texts) Paragraph 10(5)(c) the name of the medicine is displayed in a text size of not less than 1.5 millimetres (the trade name quot;FluQuadriquot; is less than 1.5 mm on syringe) Paragraph 11(1)(a) use of appropriate metric units (the abbreviation quot;mcgquot; is used rather than quot;microgramquot; in full on carton) Subsection 11(5) permitted statements of storage temperature conditions (quot;Store between +2ÌŠ C to +8°C. Do not freezequot; is used rather than quot;Store at 2°C to 8°Cquot; (Refrigerate. Do not freeze) on carton). | 1. This consent applies only to the FluQuadri batch UI946AA. 2. A 'Dear Healthcare Professional' letter identical to that provided to the TGA on 28 May 2018 will be supplied with the affected batch. 3. Non-compliance with the European Pharmacopoeia is limited to the working seeds and tests detailed in the application submitted to the TGA on 28 May 2018; 4. Non-compliance with the TGO 91 is limited to specifications detailed in the application form submitted to the TGA on 28 May 2018. | Import and supply | Prescription medicines |
| NATULAN procarbazine 50 mg (as hydrochloride) capsule blister pack | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | 231199 | CON-267 | The consent is effective from 5 June 2018 until 31 August 2020 | 5/06/2018 | Paragraph 7(13)(a) of the Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | The blister foil label to be used does not include the name or registered trademark of the sponsor. | 1. The blister foil label to which this consent applies is provided with the application. 2. Upon receipt in Australia, the product will be re-packed into currently approved Australian cartons with the Australian printed leaflet. | Import and supply | Prescription medicines | |
| Blood and blood components | Australian Red Cross Blood Service | N/A | CON-273 | The consent is effective from 6 June 2018 until the conditions no longer remain true. | 6/06/2018 | Therapeutic Goods Order 81 - Standards for Blood and Blood Components - Council of Europe Guide to the preparation, use and quality assurance of blood components (14th edition) (CoE Guide) | Blood donations from therapeutic donors aged 16 and 17 years can be accepted and used for manufacturing blood components. | Should new information becomes available in the future, indicating changes in the safety profile of blood donations received from patients with haemochromatosis, the Sponsor must submit this data to the TGA for assessment and approval. | Supply | Blood, tissues, and biologicals | |
| Afluria Quad - Inactivated Quadrivalent Influenza vaccine (split virion), 60 mcg HA, Suspension for injection, pre-filled syringe | Seqirus Pty Ltd | 262428 | CON-272 | The consent is effective from 15 June 2018 until 28 February 2019. | 15/06/2018 | Section 7(2)(n)(iii) of Therapeutic Goods Order No. 69 - General Requirements for Labels for Medicines 2017 (TGO 69). | The registration number is not on the primary pack label. | 1. This consent applies only to batches of Afluria Quad with a manufacturing date after 15 June 2018. 2. All batches manufactured as mentioned above are to have an expiry date not later than 28 February 2019.3. A ‘Dear Healthcare Professional’ letter identical to that provided to the TGA with the submission on 6th June 2018 will be supplied with the affected batches.4. Non-compliance with the TGO 69 is limited to specifications detailed in the application form submitted to the TGA on 6th June 2018. | Supply | Prescription medicines | |
| NAPHCON FORTE naphazoline hydrochloride 1 mg/mL eye drops bottle | Alcon Laboratories (Australia) Pty Ltd | 10231 | CON-270 | The consent is effective from 15 June 2018 until 30 May 2020 | 15/06/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General Requirements for Labels for Medicines 2017 | The product labels do not contain the current address for the sponsor. | Arrangements are in place to redirect all mail from Alcon’s previous address to the current address in Macquarie Park. | Import and supply | Over-the-counter medicines | |
| NAPHCON-A eye drops bottle | Alcon Laboratories (Australia) Pty Ltd | 47652 | CON-270 | The consent is effective from 15 June 2018 until 30 May 2020 | 15/06/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General Requirements for Labels for Medicines 2017 | The product labels do not contain the current address for the sponsor. | Arrangements are in place to redirect all mail from Alcon’s previous address to the current address in Macquarie Park. | Import and supply | Over-the-counter medicines | |
| SYSTANE RED EYES naphazoline hydrochloride 1 mg/mL eye drops bottle | Alcon Laboratories (Australia) Pty Ltd | 286697 | CON-269 | The consent is effective from 15 June 2018 until 30 May 2020 | 15/06/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General Requirements for Labels for Medicines 2017 | The product label does not contain the name of the current sponsor (but contains the correct address). | Import and supply | Over-the-counter medicines | ||
| FluQuadri Inactivated Quadrivalent Influenza Vaccine (Split Virion), Influenza virus haemagglutinin 60 mcg, 0.5 mL suspension for injection | Sanofi Aventis Australia Pty Ltd | 213963 | UI936AA | CON-274 | The consent is effective from 19 June 2018 until 28 February 2019. | 19/06/2018 | 1. European Pharmacopoeia (01/2008:0158) 2. Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | 1.The test for Bacterial Endotoxins (2.6.14) and the assay of Haemagglutinin Antigen by an immunodiffusion test (2.7.1), are performed on the Final Bulk Product only and not performed on the Final Filled product. 2. The batch is packaged in the Standard Export labelling (in Spanish and English), which does not conform with the requirements of the TGO 91 on the following%2358;• Paragraph 8(1)(d) the name of the dosage form (missing on carton)• Paragraph 8(1)(i) the name and contact details of the sponsor (missing on carton)• Paragraph 8(1)(j)(iv)(A) indicating that the medicine contains the substance expressed using the Name stated in Column 4 of Schedule 1 (statement regarding manufactured in eggs missing on carton)• Paragraph 9(1)(b) the name(s) of all active ingredients in the medicine (missing on syringe)• Paragraph 9(1)(c) the quantity or proportion of all active ingredients in the medicine (missing on syringe)•Subsection 9(3) the name of the medicine and the name of active ingredients on the main label (they are placed separately as the same texts in Spanish are placed before English texts)• Paragraph 10(5)(c) the name of the medicine is displayed in a text size of not less than 1.5 millimetres (the trade name “FluQuadri” is less than 1.5 mm on syringe)• Paragraph 11(1)(a) use of appropriate metric units (the abbreviation “mcg” is used rather than “microgram” in full on carton)• Subsection 11(5) permitted statements of storage temperature conditions (“Store between + 2ÌŠ C t o +8ÌŠ C . Do not freeze” is used rather than “Store at 2oC t o 8oC” (Refrigerate. Do not freeze) on carton). | 1. This consent applies only to the FluQuadri batch UI936AA.2. A ‘Dear Healthcare Professional’ letter identical to that provided to the TGA on 7 June 2018 will be supplied with the affected batch.3. Non-compliance with the European Pharmacopoeia is limited to the tests detailed in the application submitted to the TGA on 7 June 2018;4. Non-compliance with the TGO 91 is limited to specifications detailed in the application submitted to the TGA on 7 June 2018. | Import and supply | Prescription medicines |
| FLUARIX TETRA inactivated split influenza vaccine suspension for injection 0.5mL pre-filled PRTC syringe without needle | GlaxoSmithKline Australia Pty Ltd | 242512 | AFLBA290AB, Expiry 31 December 2018, Quantity 19,900 doses, (19,900 x single syringe pack) | CON-275 | The consent is effective from the 27 June 2018 until 31 December 2018 (date of expiry for the referred batch). | 27/06/2018 | Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines | Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)- The batch is packaged in the General Export Pack, which does not conform with the requirements of the TGO 91 on the following%2358; Paragraph 8(1)(b) – the name(s) of all active ingredients in the medicine – the name of the active ingredient (influenza virus haemagglutinin) is not explicitly stated – either on the carton Paragraphs 8(1)(f) and (g) the formatting of the batch number prefix and the expiry date prefix does not comply. Paragraph 8(1)(i) The name and contact details of the Australian sponsor are not provided. Paragraph 8(1)(j)(A) - the statement indicating the product is manufactured in eggs is missing. Paragraph 8(1)(k) statements of 'Medicinal product subject to medical prescription' and 'Keep out of the sight and reach of children' are misplaced and does not include the text 'For use in 3 years and above only' and text 'Do not accept if seal is broken' Paragraph 8(1)(n) a machine-readable code is not present. Paragraph 8(1)(o) The name of the medicine is not included on three non-opposing sides of the carton. Paragraph 9(3)(a)(i) the placement of the medicine name and the active ingredient does not comply. Subsection 9(5) the quantity of the active ingredients is not displayed in a text size of not less than 3.0 millimetres. Paragraph 10(5)(e)(f) The container label has incorrect placement of the prefixes for the batch number and expiry dates. Paragraph 10(5)(h) the content of the active ingredient is not included i.e. quot;60 mg HAquot; being the acceptable abbreviation. Subsection 11(5) The permitted statement quot;Store at 2ËšC to 8ËšC (Refrigerate. Do not freeze)quot; is not applied correctly (the carton states Storage%2358; 2ËšC - 8ËšC). | 1. This consent applies only to the Fluarix Tetra batch AFLBA290AB. 2. A 'Dear Healthcare Professional' letter identical to that provided to the TGA on 26 June 2018 will be supplied with the affected batch. 3 .Non-compliance with the Therapeutic Goods Order No. 91 is limited to specifications detailed in the application form submitted to the TGA on 14 June 2018 and amended in the email of 21 June 2018 | Import and supply | Prescription medicines |
| CISPLATIN INTAS cisplatin 25 mg/25 mL concentrated injection vial | Accord Healthcare Pty Ltd | 286787 | CON-279 | The consent is effective from 5 July 2018 until further notice. | 5/07/2018 | Paragraphs 8(1)(i) and 8(1)(n) of the Therapeutic Goods Order No 91 - Standard for labels of prescription and related medicines | The product labels do not have sufficient space to include the name and contact details of the sponsor and the machine readable code on the vial label. | 1. the vials will be supllied in a carton that complies with all of the requirements of the Therapeutic Goods Order No.91. 2. The approved labels are those approved during review of the registration application. | Import and supply | Prescription medicines | |
| CISPLATIN ACCORD cisplatin 25 mg/25 mL concentrated injection vial | Accord Healthcare Pty Ltd | 286793 | CON-279 | The consent is effective from 5 July 2018 until further notice. | 5/07/2018 | Paragraphs 8(1)(i) and 8(1)(n) of the Therapeutic Goods Order No 91 - Standard for labels of prescription and related medicines | The product labels do not have sufficient space to include the name and contact details of the sponsor and the machine readable code on the vial label. | 1. the vials will be supllied in a carton that complies with all of the requirements of the Therapeutic Goods Order No.91. 2. The approved labels are those approved during review of the registration application. | Import and supply | Prescription medicines | |
| BD ChloraPrep Clear cutaneous solution applicator | Becton Dickinson Pty Ltd | 277601 | CON-276 | The consent is effective from the 5 July 2018 until 31 July 2020 | 5/07/2018 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 92 – Standard for labels for non-prescription medicines | The labels display the name and address of the previous sponsor CareFusion 316 Pty Ltd instead of the current sponsor. | Arrangements are in place for the prompt referral of any queries or complaints concerning the products to Becton Dickinson Pty Ltd [the current sponsor]. | Import and supply | Over-the-counter medicines | |
| BD ChloraPrep with Tint cutaneous solution applicator | Becton Dickinson Pty Ltd | 221654 | CON-276 | The consent is effective from the 5 July 2018 until 31 July 2020 | 5/07/2018 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 92 – Standard for labels for non-prescription medicines | The labels display the name and address of the previous sponsor CareFusion 316 Pty Ltd instead of the current sponsor. | Arrangements are in place for the prompt referral of any queries or complaints concerning the products to Becton Dickinson Pty Ltd [the current sponsor]. | Import and supply | Over-the-counter medicines | |
| NUROFEN FOR CHILDREN 3 MONTHS - 5 YEARS strawberry flavour ibuprofen 100mg/5mL suspension bottle (new) | Reckitt Benckiser Australia Pty Ltd | 118807 | 8159D2 | CON-278 | The consent is effective from the 6 July 2018 until 30 June 2019. | 6/07/2018 | Subparagraphs 9(7)(a) and 9(7)(a)(i) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines. | The font sizes of the active ingredient on the carton labels and the 50mL bottle label do not comply with the active ingredient font size requirements specified in subparagraphs 9(7)(a) and 9(7)(a)(i), respectively. | Supply | Over-the-counter medicines | |
| CHEMISTS OWN COLD SORE CREAM aciclovir 5% w/w tube | Arrow Pharma Pty Ltd | 106588 | CON-277 | The consent is effective from 6 July 2018 until 31 March 2019. | 6/07/2018 | Section 8 of the Therapeutic Goods Order No. 77 – Microbiological Standards for Medicines. | The product does not comply with the acceptance criteria specified in the British Pharmacopoeia Test for Efficacy of Antimicrobial Preservation for Aspergillus brasiliensis. | The product must meet the acceptance criteria for Aspergillus brasiliensis specified in the USP General Chapter lt;51gt; Antimicrobial Effectiveness Testing. | Supply | Over-the-counter medicines | |
| Breathe Easier | Heritage Brand Ltd | 296170 | 09725U | CON-259 | The consent is effective from 9 July 2018 until 31 December 2018. | 9/07/2018 | Paragraphs 7(1)(b) and 7(2)(n) of the Therapeutic Goods Order No. 69 - General requirements for labels of medicines. | The labels do not include the correct AUST L number for the product on the main label. | Supply | Listed complementary medicines | |
| Elastoplast 4.8 mg Heat Plaster | Beiersdorf Health Care Australia Pty Ltd | 282621 | CON-252 | The consent is effective from the 9 July 2018 until 31 August 2020. | 9/07/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines (TGO 69) | The labels do not include the correct name of the sponsor or supplier of the products. | The labels to which this consent applies are those previously approved for the former sponsor Beiersdorf Australia Limited, and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to the current sponsor, Beiersdorf Health Care Australia Pty Ltd. | Import and supply | Listed complementary medicines | |
| Elastoplast ABC Heat Plaster | Beiersdorf Health Care Australia Pty Ltd | 126550 | CON-252 | The consent is effective from the 9 July 2018 until 31 August 2020. | 9/07/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines (TGO 69) | The labels do not include the correct name of the sponsor or supplier of the products. | The labels to which this consent applies are those previously approved for the former sponsor Beiersdorf Australia Limited, and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to the current sponsor, Beiersdorf Health Care Australia Pty Ltd. | Import and supply | Listed complementary medicines | |
| Blood and blood components | Australian Red Cross Blood Service | N/A | CON-287 | The consent is effective from the 20 July 2018 until the following conditions no longer remain true. | 20/07/2018 | The deferral period for donors with a history of coronary artery disease in the Council of Europe Guide to the preparation, use and quality assurance of blood components (14th edition) (CoE Guide), as specified in Therapeutic Goods Order No. 81 - Standards for Blood and Blood Components | People who have a history of coronary artery disease can be accepted as blood donors if they meet the new criteria outlined in the Guidelines for the Selection of Blood Donors (GSBD). | Should new information becomes available in the future, indicating that the blood donation is having a negative impact on the health and safety of patients with a history of coronary artery disease, the ARCBS must submit this information to the TGA and obtain approval to continue with this exemption. | Supply | Blood, tissues, and biologicals | |
| Blood products. | Australian Red Cross Blood Service | N/A | CON-280 | The consent is effective from 20 July 2018 until the following conditions no longer remain true. | 20/07/2018 | The product does not conform to the deferral requirements of Therapeutic Goods Order No. 81 - Standards for Blood and Blood Components - Council of Europe Guide to the preparation, use and quality assurance of blood components (14th edition) (CoE Guide). | The people who have a history of coronary artery disease can be accepted as blood donors if they meet the new criteria outlined in the Guidelines for the Selection of Blood Donors (GSBD). | Should new information becomes available in the future, indicating that the blood donation is having a negative impact on the health and safety of patients with a history of coronary artery disease, the ARCBS must submit this information to the TGA and obtain approval to continue with this exemption. | Supply | Blood, tissues, and biologicals | |
| NORVIR Ritonavir 600 mg/7.5 mL oral liquid bottle | Abbvie Pty Ltd | 55004 | CON-281 | The consent is effective from the 23 July 2018 until 23 July 2020 | 23/07/2018 | Sections 8(2) and 11(1) and subsections 7(2)(c) and 7(2)(j) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines. | The product labels do not express the required quantity or proportion of the active ingredient and permitted statements of storage condition.The quantity of the active ingredient is expressed as 80 mg per mL and the storage condition is stated as 'store at room temperature (20-25°C)'. | The labels to which this consent applies are the South African labels that are provided with the application letter dated 29 May 2018, including the over-sticker for the name and address of the Australian sponsor of the product and ARTG number. | Import and supply | Prescription medicines | |
| SOOTHERS honey and lemon flavour | Nestlé Australia Ltd | 281103 | CON-283 | The consent is effective from the 6 August 2018 until 31st August 2020. | 6/08/2018 | Paragraph 7(12)(a) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | The product name, the names of the active ingredients or the quantities of the active ingredients in the goods do not appear on each individual unsealed wrappers. | The lozenges which are individually wrapped in an unsealed, protective cover are enclosed in a primary pack that complies with the TGO 69. | Supply | Listed complementary medicines | |
| Soothers Liquid Centres - Lemon Lime | Nestlé Australia Ltd | 227151 | CON-283 | The consent is effective from the 6 August 2018 until 31st August 2020. | 6/08/2018 | Paragraph 7(12)(a) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | The product name, the names of the active ingredients or the quantities of the active ingredients in the goods do not appear on each individual unsealed wrappers. | The lozenges which are individually wrapped in an unsealed, protective cover are enclosed in a primary pack that complies with the TGO 69. | Supply | Listed complementary medicines | |
| SOOTHERS BLACKCURRANT | Nestlé Australia Ltd | 278595 | CON-283 | The consent is effective from the 6 August 2018 until 31st August 2020. | 6/08/2018 | Paragraph 7(12)(a) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | The product name, the names of the active ingredients or the quantities of the active ingredients in the goods do not appear on each individual unsealed wrappers. | The lozenges which are individually wrapped in an unsealed, protective cover are enclosed in a primary pack that complies with the TGO 69. | Supply | Listed complementary medicines | |
| ENLIVA | Mylan Health Pty Ltd | 232811 | MN-001 | CON-282 | The consent is effective from the 6th August 2018 until 30 November 2019. | 6/08/2018 | Subparagraphs 10(9)(a)(vii) and (viii) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product does not include the batch number prefix and expiry date prefix on the blister foils. | Import and supply | Listed complementary medicines | |
| Cenovis Joint Repair Krill Oil + Glucosamine | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 248192 | CON-284 | The consent is effective from the 7 August 2018 until 01 March 2019. | 7/08/2018 | The United States Pharmacopeia-National Formulary (USP41-NF36) monograph for Krill Oil | The raw material complies with the USP41-NF36 monograph, with the exception of%2358;The concentrations of the fatty acids myristic acid (C14%2358;0), oleic acid (C18%2358;1 n-9) eicosapentaenoic acid (C20%2358;5 n-3) and palmitoleic acid (C16%2358;1 n-7) in the acceptance criteria for ‘Identification Test A-Fatty Acid Profile’The ratio between palmitic acid (C16%2358;0) and myristic acid (C14%2358;0) in the acceptance criteria for ‘Identification Test A-Fatty Acid Profile’The acceptance criteria ‘Content of Astaxanthin’ | Consent is given to import and supply the raw material and the products on the condition that the raw material meets the limits as set out in the table below%2358; Table 1%2358; Imposed limits for Krill oil raw material Test Limits Identification test A-Fatty acid profile Myristic acid 5.0-13.0% Oleic acid 6.0-14.5% Eicosapentaenoic acid 14.0-28.0% Palmitoleic acid 2.5-12.0% Ratio between fatty acids Palmitic acid and myristic acid 1.6-3.6% Content of Astaxanthin Astaxanthin Not less than 0.005% The raw material and products in relation to which the consent is given must comply with all other applicable parts of the USP40-NF35 and all other applicable standards | Import and supply | Listed complementary medicines | |
| Nature’s Own Ultra Krill Oil 1500mg | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 212127 | CON-284 | The consent is effective from the 7 August 2018 until 01 March 2019. | 7/08/2018 | The United States Pharmacopeia-National Formulary (USP41-NF36) monograph for Krill Oil | The raw material complies with the USP41-NF36 monograph, with the exception of%2358;The concentrations of the fatty acids myristic acid (C14%2358;0), oleic acid (C18%2358;1 n-9) eicosapentaenoic acid (C20%2358;5 n-3) and palmitoleic acid (C16%2358;1 n-7) in the acceptance criteria for ‘Identification Test A-Fatty Acid Profile’The ratio between palmitic acid (C16%2358;0) and myristic acid (C14%2358;0) in the acceptance criteria for ‘Identification Test A-Fatty Acid Profile’The acceptance criteria ‘Content of Astaxanthin’ | Consent is given to import and supply the raw material and the products on the condition that the raw material meets the limits as set out in the table below%2358; Table 1%2358; Imposed limits for Krill oil raw material Test Limits Identification test A-Fatty acid profile Myristic acid 5.0-13.0% Oleic acid 6.0-14.5% Eicosapentaenoic acid 14.0-28.0% Palmitoleic acid 2.5-12.0% Ratio between fatty acids Palmitic acid and myristic acid 1.6-3.6% Content of Astaxanthin Astaxanthin Not less than 0.005% The raw material and products in relation to which the consent is given must comply with all other applicable parts of the USP40-NF35 and all other applicable standards | Import and supply | Listed complementary medicines | |
| Nature's Own Mega Krill Oil 2000mg | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 212133 | CON-284 | The consent is effective from the 7 August 2018 until 01 March 2019. | 7/08/2018 | The United States Pharmacopeia-National Formulary (USP41-NF36) monograph for Krill Oil | The raw material complies with the USP41-NF36 monograph, with the exception of%2358;The concentrations of the fatty acids myristic acid (C14%2358;0), oleic acid (C18%2358;1 n-9) eicosapentaenoic acid (C20%2358;5 n-3) and palmitoleic acid (C16%2358;1 n-7) in the acceptance criteria for ‘Identification Test A-Fatty Acid Profile’The ratio between palmitic acid (C16%2358;0) and myristic acid (C14%2358;0) in the acceptance criteria for ‘Identification Test A-Fatty Acid Profile’The acceptance criteria ‘Content of Astaxanthin’ | Consent is given to import and supply the raw material and the products on the condition that the raw material meets the limits as set out in the table below%2358; Table 1%2358; Imposed limits for Krill oil raw material Test Limits Identification test A-Fatty acid profile Myristic acid 5.0-13.0% Oleic acid 6.0-14.5% Eicosapentaenoic acid 14.0-28.0% Palmitoleic acid 2.5-12.0% Ratio between fatty acids Palmitic acid and myristic acid 1.6-3.6% Content of Astaxanthin Astaxanthin Not less than 0.005% The raw material and products in relation to which the consent is given must comply with all other applicable parts of the USP40-NF35 and all other applicable standards | Import and supply | Listed complementary medicines | |
| Nature's Own Ultra Krill Oil 1000mg | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 211039 | CON-284 | The consent is effective from the 7 August 2018 until 01 March 2019. | 7/08/2018 | The United States Pharmacopeia-National Formulary (USP41-NF36) monograph for Krill Oil | The raw material complies with the USP41-NF36 monograph, with the exception of%2358;The concentrations of the fatty acids myristic acid (C14%2358;0), oleic acid (C18%2358;1 n-9) eicosapentaenoic acid (C20%2358;5 n-3) and palmitoleic acid (C16%2358;1 n-7) in the acceptance criteria for ‘Identification Test A-Fatty Acid Profile’The ratio between palmitic acid (C16%2358;0) and myristic acid (C14%2358;0) in the acceptance criteria for ‘Identification Test A-Fatty Acid Profile’The acceptance criteria ‘Content of Astaxanthin’ | Consent is given to import and supply the raw material and the products on the condition that the raw material meets the limits as set out in the table below%2358; Table 1%2358; Imposed limits for Krill oil raw material Test Limits Identification test A-Fatty acid profile Myristic acid 5.0-13.0% Oleic acid 6.0-14.5% Eicosapentaenoic acid 14.0-28.0% Palmitoleic acid 2.5-12.0% Ratio between fatty acids Palmitic acid and myristic acid 1.6-3.6% Content of Astaxanthin Astaxanthin Not less than 0.005% The raw material and products in relation to which the consent is given must comply with all other applicable parts of the USP40-NF35 and all other applicable standards | Import and supply | Listed complementary medicines | |
| TACHOSIL human fibrinogen 5.5mg/square cm and human thrombin 2.0IU/square cm medicated sponge blister pack | Takeda Pharmaceuticals Australia Pty Ltd | 176631 | CON-285 | The consent is effective from the 8 August 2018 until further notice. | 8/08/2018 | Paragraphs 10(13)(a)(vi) and 10(13)(a)(vii) of Therapeutic Goods Order No. 91 - Standard for labels for prescription and related medicines. | The product’s immediate blister pack labels do not include the names and quantities of all active ingredients in the medicine. | The labels to which this consent applies are those previously approved to be exempted from compliance with subclauses 3(12)(b) and 3(2)(b) and (c) of the Therapeutic Goods Order No. 69 - General Requirements for Labels for Medicines. | Supply | Prescription medicines | |
| Blood and blood components | Australian Red Cross Blood Service | N/A | CON-286 | This consent is effective from the 10 August 2018 until Friday 11 August 2023. | 10/08/2018 | Medical review requirements for donors aged 60 years and over - Council of Europe Guide to the preparation, use and quality assurance of blood components 14th Edition, as specified in Therapeutic Goods Order No. 81 - Standards for Blood and Blood Components | First time donors over the age of 60 years and less than 81 years (exclusive) can be accepted without medical review. Repeat and regular donors aged 65 years and older may be accepted without the need for a medical review. There is no upper age limit for repeat and regular donors. | Products in relation to which this consent is given must comply with all other applicable requirements of the Council of Europe Guide to the preparation, use and quality assurance of blood components 14th Edition that are applicable under Therapeutic Goods Order No. 81 and other applicable standards. | Supply | Blood, tissues, and biologicals | |
| Calcium + Vitamin D3 K2 | Australian NaturalCare Products Pty Ltd | 299948 | T1813 | CON-289 | The consent is effective from 14 August 2018 until 28th February 2019. | 14/08/2018 | Calcium content requirements in Schedule 1 of Therapeutic Goods Order No 78 - Standard for tablets and capsules (TGO 78) | The result for calcium assay is 282.92mg/tablet (157.0% of the label claim) | The content of calcium must be no less than 90.0% and no more than 157.0% of the stated content on the label. | Supply | Listed complementary medicines |
| Pregnancy Plus Iodine Tablet | Catalent Australia Pty Ltd | 308184 | CON-288 | The consent is effective from the 14 August 2018. | 14/08/2018 | Subsections 11(a), 11(b) and 11(c) of the Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules (TGO78). | Subsection 11(a) requires that a registered tablet or capsule without an individual British Pharmacopoeia (BP) monograph must comply with the test for Uniformity of Dosage Units of the BP, in the general monographs ‘Tablets’ or ‘Capsules’, respectively. With respect to a registered tablet or capsule without an individual BP monograph, subsection 11(b) requires that the average content of each active ingredient in a pooled sample of not fewer than 20 tablets or capsules must be not less than 92.5% and not more than 107.5 % of the stated content of that active ingredient. With respect to subsection 11(c), TGO 78 requires that a registered tablet or capsule without an individual BP monograph must comply with a suitable test for dissolution that demonstrates the appropriate release of each active ingredient for which the BP or United States Pharmacopeia-National Formulary (USP-NF) includes an individual monograph for a tablet or capsule and requires a test for dissolution. | 1. The goods are not required to comply with TGO 78 subsection 11(a) but must comply with the requirements of the British Pharmacopoeia Appendix XII C Uniformity of Weight (Mass). 2. The goods are not required to comply with TGO 78 subsection 11(b) but the average content of each active ingredient in the goods must comply with the relevant acceptance criteria in the below tables%2358; FINISHED PRODUCT SPECIFICATIONS TO WHICH THE GOODS MUST CONFORM Test Acceptance criteria Appearance White film coated, oval shaped tablets. Uniformity of mass Meets the requirements of Uniformity of Weight (Mass), Appendix XII C of the British Pharmacopoeia. Average mass 1277mg ±5% (1214-1340mg) Disintegration time Meets the requirements for disintegration for film coated tablets of the British Pharmacopoeia, Formulated preparations%2358; General monographs for Tablets. Dissolution - folic acid Meets the requirements of United States Pharmacopeia-National Formulary, Dietary Supplement Chapter lt;2040gt; 'Disintegration and Dissolution of Dietary Supplements'. Dissolution - riboflavin (Vitamin B2) Meets the requirements of United States Pharmacopeia-National Formulary, Dietary Supplement Chapter lt;2040gt; 'Disintegration and Dissolution of Dietary Supplements'. Dissolution - iron Meets the requirements of United States Pharmacopeia-National Formulary, Dietary Supplement Chapter lt;2040gt; 'Disintegration and Dissolution of Dietary Supplements'. Identification Thiamine (Vitamin B1) Complies Riboflavin (Vitamin B2) Complies Nicotinamide Complies Pantothenic acid (Vitamin B5) Complies Pyridoxine (Vitamin B6) Complies Cyanocobalamin (Vitamin B12) Complies Ascorbic Acid (Vitamin C) Complies Colecalciferol (Vitamin D3) Complies dl-alpha tocopherol (Vitamin E) Complies Biotin (Vitamin H) Complies Folic acid Complies Calcium Complies Copper Complies Iodine Complies Iron Complies Magnesium Complies Manganese Complies Selenium Complies Zinc Complies Acceptance criteria for Assay of Active ingredients Test (Assay) Acceptance limits (release) Acceptance limits (shelf life) Vitamin B5 (pantothenic acid as calcium pantothenate) 115.6% – 150.0% of labelled claim 90.0% – 150.0% of labelled claim Nicotinamide 115.6% – 150.0% of labelled claim 90.0% – 150.0% of labelled claim Pyridoxine (Vitamin B6, as pyridoxine hydrochloride) 115.6% – 150.0% of labelled claim 90.0% – 150.0% of labelled claim Vitamin B2 (riboflavin) 115.6% – 150.0% of labelled claim 90.0% – 150.0% of labelled claim Thiamine (Vitamin B1, as thiamine nitrate) 115.6% – 150.0% of labelled claim 90.0% – 150.0% of labelled claim Vitamin C (ascorbic acid) 115.6 – 150.0% of labelled claim 90.0% – 150.0% of labelled claim dl-alpha tocopherol (Vitamin E, as dl-alpha-tocopheryl acetate) 100.8% – 130.8% of labelled claim 90.0% – 165.0% of labelled claim Colecalciferol (as dry Vitamin D3 200IU) 129.5% – 149.8% of labelled claim 90.0% – 165.0% of labelled claim Folic acid 115.6% – 150.0% of labelled claim 90.0% – 150.0% of labelled claim Iron (as ferrous fumarate) 92.5% – 125.0% of labelled claim 90.0% – 125.0% of labelled claim Magnesium (as magnesium oxide-heavy and magnesium stearate) 92.5% – 125.0% of labelled claim 90.0% – 125.0% of labelled claim Calcium (as calcium hydrogen phosphate, calcium carbonate and calcium pantothenate) 92.5% – 125.0% of labelled claim 90.0% – 125.0% of labelled claim Zinc (as zinc citrate dihydrate) 92.5% – 125.0% of labelled claim 90.0% – 125.0% of labelled claim Copper (as cupric sulfate) 92.5% – 125.0% of labelled claim 90.0% – 125.0% of labelled claim Manganese (as manganese sulfate monohydrate) 92.5% – 125.0% of labelled claim 90.0% – 125.0% of labelled claim Iodine (as potassium iodide) 92.5% – 160.0% of labelled claim 90.0% – 160.0% of labelled claim Selenium (as sodium selenite) 92.5% – 160.0% of labelled claim 90.0% – 160.0% of labelled claim Biotin Label Claim%2358; 30.0 mcg (QBI) Label Claim%2358; 30.0 mcg (QBI) Vitamin B12 (cyanocobalamin ) Label Claim%2358; 2.60 mcg (QBI) Label Claim%2358; 2.60 mcg (QBI) Microbial requirements Test Requirement Total aerobic microbial count ≤ 104 microorganisms/g Total yeast and mould count ≤ 102 microorganisms/g Bile-tolerant Gram negative bacteria ≤ 102 microorganisms/g Salmonella Absent in 10g Escherichia coli Absent in 1g Staphylococcus aureus Absent in 1g Note%2358; Microbial testing shall be performed on first 3 production batches and at least one batch per year or when a change in the source of raw materials or manufacturing environment process occurs. 3. The goods are not required to comply with TGO 78 subsection 11(c) but must comply with the dissolution requirements of the United States Pharmacopeia-National Formulary, Dietary Supplement Chapter lt;2040gt; ‘Disintegration and Dissolution of Dietary Supplements’ for riboflavin (Vitamin B2) and iron as set out in the above tables. | Supply | Registered complementary medicines | |
| BUSULFEX busulfan 60 mg/10 mL injection vial | Otsuka Australia Pharmaceutical Pty Ltd | AUST R 150612 | CON-527 | The consent is effective from 1 August 2018 until 31 July 2020. | 15/08/2018 | Therapeutic Goods Order No. 69 - General requirements for labels for medicines | The vial labels do not conform with subclauses 3(2)(a), 3(2)(c), 3(5)(b)(i) and 3(2)(l) of Therapeutic Goods Order No. 69, in that the proposed vial label does not have the Australian-registered product name, the correct expression of the quantity of the active in the good and name or trade mark of the current sponsor (or supplier). | 1. The US vial label is to be used. 2. The US Product Information (PI) will be removed from the cartons containing the single vial and the Australian approved PI will be included inside the outer carton containing the 8 single vial cartons 3. Arrangements are in place with the former sponsor, Orphan Australia Pty Ltd, for the prompt referral of any queries or complaints concerning the products to Otsuka Australia Pharmaceutical Pty Ltd [the current sponsor]. | Import and supply | Prescription medicines | |
| KRILL OIL METAGENICS | Metagenics (Aust) Pty Ltd | 269032 | CON-290 | The consent is effective from the 22 August 2018 until 01 March 2019. | 22/08/2018 | United States Pharmacopeia-National Formulary (USP41-NF36) monograph for Krill Oil. | The raw material complies with the USP41-NF36 monograph, with the exception of%2358; The concentrations of the fatty acids myristic acid (C14%2358;0), oleic acid (C18%2358;1 n-9) and eicosapentoenoic acid (C20%2358;5 n-3) in the acceptance criteria for ‘Identification Test A-Fatty Acid Profile’ The ratio between palmitic acid (C16%2358;0) and myristic acid (C14%2358;0) in the acceptance criteria for ‘Identification Test A-Fatty Acid Profile’ The acceptance criteria ‘Content of Astaxanthin’ | Consent is given to import and supply the raw material and the products on the condition that the raw material meets the limits as set out in the table below%2358; Table 1%2358; Imposed limits for Krill oil raw material Test Limits Identification test A-Fatty acid profile Myristic acid 5.0-13.0% Oleic acid 6.0-14.5% Eicosapentanoic acid 14.0-28.0% Ratio between fatty acids Palmitic acid and myristic acid 1.6-3.6% Content of Astraxanthin Astraxanthin Not less than 0.005% The raw material and products in relation to which the consent is given must comply with all other applicable parts of the current USP41-NF36 and all other applicable standards. | Supply | Listed complementary medicines | |
| JETREA ocriplasmin 0.5 mg/0.2 mL concentrated solution for intravitreal injection vial | I-Care Pharma Distributors Pty Ltd | 206494 | 15104 | CON-297 | The consent is effective from 5 September 2018 until 30 September 2019. | 5/09/2018 | Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 – General requirements for labels for medicines | The product label does not include the name and address of the current sponsor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor Alcon Laboratories Pty Ltd.Arrangements are in place with the former sponsor Alcon Laboratories Pty Ltd for the prompt referral of any queries or complaints concerning the products to the I-Care Pharma Distributors Pty Ltd. | Import and supply | Prescription medicines |
| BUPIVADREN Bupivacaine 0.5% w/v with Adrenaline (epinephrine) 1:200,000 injection solution vial | Pfizer Australia Pty Ltd | 292528 | CON-291 | The consent is effective from the date of this letter until further notice. | 5/09/2018 | Section 10(3)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines. | The vial labels do not list the excipients and amounts. | The product labels comply with the agreed text where the vial labels do not list the excipients and amounts, but include the text 'Contains Sulfites'. | Supply | Prescription medicines | |
| PFIZER BUPIVACAINE 0.5% w/v WITH ADRENALINE (epinephrine) 1:200,000 injection solution vial | Pfizer Australia Pty Ltd | 292527 | CON-291 | The consent is effective from the date of this letter until further notice. | 5/09/2018 | Section 10(3)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines. | The vial labels do not list the excipients and amounts. | The product labels comply with the agreed text where the vial labels do not list the excipients and amounts, but include the text 'Contains Sulfites'. | Supply | Prescription medicines | |
| BUPIVADREN Bupivacaine 0.25% w/v with Adrenaline (epinephrine) 1:400,000 injection solution vial | Pfizer Australia Pty Ltd | 292526 | CON-291 | The consent is effective from the date of this letter until further notice. | 5/09/2018 | Section 10(3)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines. | The vial labels do not list the excipients and amounts. | The product labels comply with the agreed text where the vial labels do not list the excipients and amounts, but include the text 'Contains Sulfites'. | Supply | Prescription medicines | |
| PFIZER BUPIVACAINE 0.25% w/v WITH ADRENALINE (epinephrine) 1:400,000 injection solution vial | Pfizer Australia Pty Ltd | 292525 | CON-291 | The consent is effective from the date of this letter until further notice. | 5/09/2018 | Section 10(3)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines. | The vial labels do not list the excipients and amounts. | The product labels comply with the agreed text where the vial labels do not list the excipients and amounts, but include the text 'Contains Sulfites'. | Supply | Prescription medicines | |
| FASENRA benralizumab 30 mg in 1 mL solution for injection prefilled syringe | AstraZeneca Pty Ltd | 285718 | 024E 17-2J | CON-293 | The consent is effective from 18 September 2018 until October 2020. | 18/09/2018 | Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines. | The product label does not comply with the following Therapeutic Goods Order No.91 requirements%2358; 7(2)(d)(i)%2358; Does not have registration number 8(1)(i)%2358; Does not have name and contact details of the sponsor 9(3)(a)(i)%2358; The location of the active ingredient name and quantity in relation to the tradename 10(3)(a)(i)%2358; Does not have the quantity of all excipients and the name of one excipient 10(3)(b)%2358; Does not have the statement quot;Use in one patient on one occasion only. Contains no antimicrobial preservative.quot; 11(2)(f)(v)%2358; The expression of the active ingredient quantity on the main panel 11(5)(iii)%2358; Does not have the required storage conditions statements | The labels to which this consent applies are those provided for this specific batch with UK labels. Arrangements are in place to include a health care professional letter with FASENRA dispensed by iCare Pharmacy or other relevant pharmacies. | Import and supply | Prescription medicines |
| Pharmacy Care Glucosamine Wild Krill | Sigma Healthcare Limited | 223580 | CON-301 | The consent is effective from 4 October 2018 until 01 March 2019. | 4/10/2018 | United States Pharmacopeia-National Formulary (USP41-NF36) monograph for Krill Oil | The products do not comply with the of the United States Pharmacopeia-National Formulary (USP41-NF36) monograph for Krill Oil (Euphausia superba oil; referred to hereinafter as 'raw material') used in the manufacture of theproducts. | Consent is given to import and supply the raw material and the products on the condition that the raw material meets the limits as set out in the table belowTable 1 Imposed limits for Krill oil raw materialTestLimits1.Identification test A-Fatty acid profileMyristic acid5.0-13.0%Oleic acid6.0-14.5%Eicosapentanoic acid14.0-28.0%2.Ratio between fatty acidsPalmitic acid and myristic acid1.6-3.6%3.Content of AstraxanthinAstraxanthinNot less than 0.005%4.Content of total lipidsSum of Sum of phosphatidylcholine, 1-lysophosphatidylcholine, and 2-lysophosphatidylcholine-60-90%The above limits are consistent with the proposed revision in the Second Supplement to USP41-NF36 monograph for Krill oil. | Import and supply | Listed complementary medicines | |
| AMCAL Glucosamine Plus Wild Krill | Sigma Healthcare Limited | 223640 | CON-301 | The consent is effective from 4 October 2018 until 01 March 2019. | 4/10/2018 | United States Pharmacopeia-National Formulary (USP41-NF36) monograph for Krill Oil | The products do not comply with the of the United States Pharmacopeia-National Formulary (USP41-NF36) monograph for Krill Oil (Euphausia superba oil; referred to hereinafter as 'raw material') used in the manufacture of theproducts. | Consent is given to import and supply the raw material and the products on the condition that the raw material meets the limits as set out in the table belowTable 1 Imposed limits for Krill oil raw materialTestLimits1.Identification test A-Fatty acid profileMyristic acid5.0-13.0%Oleic acid6.0-14.5%Eicosapentanoic acid14.0-28.0%2.Ratio between fatty acidsPalmitic acid and myristic acid1.6-3.6%3.Content of AstraxanthinAstraxanthinNot less than 0.005%4.Content of total lipidsSum of Sum of phosphatidylcholine, 1-lysophosphatidylcholine, and 2-lysophosphatidylcholine-60-90%The above limits are consistent with the proposed revision in the Second Supplement to USP41-NF36 monograph for Krill oil. | Import and supply | Listed complementary medicines | |
| PHARMACY CARE WILD KRILL 1000 MG | Sigma Healthcare Limited | 213191 | CON-301 | The consent is effective from 4 October 2018 until 01 March 2019. | 4/10/2018 | United States Pharmacopeia-National Formulary (USP41-NF36) monograph for Krill Oil | The products do not comply with the of the United States Pharmacopeia-National Formulary (USP41-NF36) monograph for Krill Oil (Euphausia superba oil; referred to hereinafter as 'raw material') used in the manufacture of theproducts. | Consent is given to import and supply the raw material and the products on the condition that the raw material meets the limits as set out in the table belowTable 1 Imposed limits for Krill oil raw materialTestLimits1.Identification test A-Fatty acid profileMyristic acid5.0-13.0%Oleic acid6.0-14.5%Eicosapentanoic acid14.0-28.0%2.Ratio between fatty acidsPalmitic acid and myristic acid1.6-3.6%3.Content of AstraxanthinAstraxanthinNot less than 0.005%4.Content of total lipidsSum of Sum of phosphatidylcholine, 1-lysophosphatidylcholine, and 2-lysophosphatidylcholine-60-90%The above limits are consistent with the proposed revision in the Second Supplement to USP41-NF36 monograph for Krill oil. | Import and supply | Listed complementary medicines | |
| AMCAL WILD KRILL 1000 | Sigma Healthcare Limited | 205899 | CON-301 | The consent is effective from 4 October 2018 until 01 March 2019. | 4/10/2018 | United States Pharmacopeia-National Formulary (USP41-NF36) monograph for Krill Oil | The products do not comply with the of the United States Pharmacopeia-National Formulary (USP41-NF36) monograph for Krill Oil (Euphausia superba oil; referred to hereinafter as 'raw material') used in the manufacture of theproducts. | Consent is given to import and supply the raw material and the products on the condition that the raw material meets the limits as set out in the table belowTable 1 Imposed limits for Krill oil raw materialTestLimits1.Identification test A-Fatty acid profileMyristic acid5.0-13.0%Oleic acid6.0-14.5%Eicosapentanoic acid14.0-28.0%2.Ratio between fatty acidsPalmitic acid and myristic acid1.6-3.6%3.Content of AstraxanthinAstraxanthinNot less than 0.005%4.Content of total lipidsSum of Sum of phosphatidylcholine, 1-lysophosphatidylcholine, and 2-lysophosphatidylcholine-60-90%The above limits are consistent with the proposed revision in the Second Supplement to USP41-NF36 monograph for Krill oil. | Import and supply | Listed complementary medicines | |
| ORGARAN danaparoid sodium 750 anti-Xa units per 0.6mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 46096 | CON-295 | The consent is effective from 9 October 2018 until the anti-Xa potency limit in the European Pharmacopoeia monograph for Danaparoid Sodium is updated. | 9/10/2018 | European Pharmacopoeia monograph for Danaparoid Sodium | The limit for anti-Xa potency has been widened from 11.0 - 17.0 U/mg to 11.0 - 19.0 U/mg for both ORGARAN drug substance and drug product. | Only the product indicated is covered by this consent. | Import and supply | Prescription medicines | |
| NICOTINELL PEPPERMINT LOZENGES nicotine (as nicotine polacrilex) 4 mg lozenge blister pack | Orion Laboratories Pty Ltd T/A Perrigo Australia | 276926 | 8GW0070 - Expiry 31 May 2020 8GW0069 - Expiry 31 May 2020 | CON-296 | The consent is effective from 10 October 2018 until the expiry date of the batches of the products. | 10/10/2018 | Subsection 10(9)(a)(v) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines. | The foil labels do not include the full Australian Approved Name (AAN) of the active ingredient in that the name of the active ingredient on the blister foil label is expressed as ‘Nicotine’ rather than ‘Nicotine (as polacrilex)’. | Import and supply | Registered complementary medicines | |
| NICOTINELL PEPPERMINT LOZENGES nicotine (as nicotine polacrilex) 2 mg lozenge blister pack | Orion Laboratories Pty Ltd T/A Perrigo Australia | 276925 | 8FW0055 - Expiry 30 April 2020 8GW0013 - Expiry 31 May 2020 8GW0012 - Expiry 31 May 2020 | CON-296 | The consent is effective from 10 October 2018 until the expiry date of the batches of the products. | 10/10/2018 | Subsection 10(9)(a)(v) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines. | The foil labels do not include the full Australian Approved Name (AAN) of the active ingredient in that the name of the active ingredient on the blister foil label is expressed as ‘Nicotine’ rather than ‘Nicotine (as polacrilex)’. | Import and supply | Registered complementary medicines | |
| RIXONFYA rituximab (rch) 100 mg/10 mL concentrated injection vial | Sandoz Pty Ltd | 309669 | CON-298 | Permanent exemption. | 15/10/2018 | Paragraph 8(1)(n) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines. | The vial labels do not include a machine readable code which complies with that defined in Therapeutic Goods Order No 91 - Standard for labels of prescription and related medicines. | This consent applies only toRIXVYDA rituximab (rch) concentrated injection vial containing 100mg/10mLRIXVYDA rituximab (rch) concentrated injection vial containing 500mg/50mLRIXONFYA rituximab (rch) concentrated injection vial containing 100mg/10mLRIXONFYA rituximab (rch) concentrated injection vial containing 500mg/50mL | Import and supply | Prescription medicines | |
| RIXONFYA rituximab (rch) 500 mg/50 mL concentrated injection vial | Sandoz Pty Ltd | 309670 | CON-298 | Permanent exemption. | 15/10/2018 | Paragraph 8(1)(n) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines. | The vial labels do not include a machine readable code which complies with that defined in Therapeutic Goods Order No 91 - Standard for labels of prescription and related medicines. | This consent applies only toRIXVYDA rituximab (rch) concentrated injection vial containing 100mg/10mLRIXVYDA rituximab (rch) concentrated injection vial containing 500mg/50mLRIXONFYA rituximab (rch) concentrated injection vial containing 100mg/10mLRIXONFYA rituximab (rch) concentrated injection vial containing 500mg/50mL | Import and supply | Prescription medicines | |
| RIXVYDA rituximab (rch) 500 mg/50 mL concentrated injection vial | Sandoz Pty Ltd | 309668 | CON-298 | Permanent exemption. | 15/10/2018 | Paragraph 8(1)(n) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines. | The vial labels do not include a machine readable code which complies with that defined in Therapeutic Goods Order No 91 - Standard for labels of prescription and related medicines. | This consent applies only toRIXVYDA rituximab (rch) concentrated injection vial containing 100mg/10mLRIXVYDA rituximab (rch) concentrated injection vial containing 500mg/50mLRIXONFYA rituximab (rch) concentrated injection vial containing 100mg/10mLRIXONFYA rituximab (rch) concentrated injection vial containing 500mg/50mL | Import and supply | Prescription medicines | |
| RIXVYDA rituximab (rch) 100 mg/10 mL concentrated injection vial | Sandoz Pty Ltd | 309667 | CON-298 | Permanent exemption. | 15/10/2018 | Paragraph 8(1)(n) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines. | The vial labels do not include a machine readable code which complies with that defined in Therapeutic Goods Order No 91 - Standard for labels of prescription and related medicines. | This consent applies only toRIXVYDA rituximab (rch) concentrated injection vial containing 100mg/10mLRIXVYDA rituximab (rch) concentrated injection vial containing 500mg/50mLRIXONFYA rituximab (rch) concentrated injection vial containing 100mg/10mLRIXONFYA rituximab (rch) concentrated injection vial containing 500mg/50mL | Import and supply | Prescription medicines | |
| MULTI VITAMINS MINERALS | Australian Naturalcare Products Pty Ltd | 130777 | 81133 | CON-302 | The consent is effective from 23 October 2018 until 30 September 2019. | 23/10/2018 | Section 10 (b) of the Therapeutic Goods Order No.78 - Standard for Tablets and Capsules (TGO 78) for an active ingredient included in a group of Schedule 1 of the Order. | The productdoes not comply with the upper limit of 150.0 per cent of the stated content for an active ingredient. | The content of retinyl acetate must be no less than 90% and no more than 174% of the stated content on the label. | Supply | Listed complementary medicines |
| SEVELAMER-RZ sevelamer carbonate 800 mg film-coated tablet bottle | Dr Reddy’s Laboratories (Australia) Pty Ltd | 286651 | CON-303 | The consent is effective from the 2 November 2018 until 1 April 2019 (the expiry date of TGO 78) or an individual BP monograph for the finished product comes into effect, whichever is sooner. | 2/11/2018 | Subsection 11(b) of the Therapeutic Goods Order No. 78 Standard for Tablets and Capsules (TGO 78). | The products do not meet the assay limits of 92.5-107.5% for the stated content of sevelamer carbonate. | The products conform to the agreed assay titratable amines limit using the agreed assay titratable amines test. The limits to be applied for the content of sevelamer carbonate must be 90.0-110.0 % of labelled claim. | Import and supply | Prescription medicines | |
| SEVELAMER-DRLA sevelamer carbonate 800 mg film-coated tablet bottle | Dr Reddy’s Laboratories (Australia) Pty Ltd | 286650 | CON-303 | The consent is effective from the 2 November 2018 until 1 April 2019 (the expiry date of TGO 78) or an individual BP monograph for the finished product comes into effect, whichever is sooner. | 2/11/2018 | Subsection 11(b) of the Therapeutic Goods Order No. 78 Standard for Tablets and Capsules (TGO 78). | The products do not meet the assay limits of 92.5-107.5% for the stated content of sevelamer carbonate. | The products conform to the agreed assay titratable amines limit using the agreed assay titratable amines test. The limits to be applied for the content of sevelamer carbonate must be 90.0-110.0 % of labelled claim. | Import and supply | Prescription medicines | |
| SEVELAMER-REDDY'S sevelamer carbonate 800 mg film-coated tablet bottle | Dr Reddy’s Laboratories (Australia) Pty Ltd | 286649 | CON-303 | The consent is effective from the 2 November 2018 until 1 April 2019 (the expiry date of TGO 78) or an individual BP monograph for the finished product comes into effect, whichever is sooner. | 2/11/2018 | Subsection 11(b) of the Therapeutic Goods Order No. 78 Standard for Tablets and Capsules (TGO 78). | The products do not meet the assay limits of 92.5-107.5% for the stated content of sevelamer carbonate. | The products conform to the agreed assay titratable amines limit using the agreed assay titratable amines test. The limits to be applied for the content of sevelamer carbonate must be 90.0-110.0 % of labelled claim. | Import and supply | Prescription medicines | |
| SEVELAMER DR.REDDY'S sevelamer carbonate 800 mg film-coated tablet bottle | Dr Reddy’s Laboratories (Australia) Pty Ltd | 286648 | CON-303 | The consent is effective from the 2 November 2018 until 1 April 2019 (the expiry date of TGO 78) or an individual BP monograph for the finished product comes into effect, whichever is sooner. | 2/11/2018 | Subsection 11(b) of the Therapeutic Goods Order No. 78 Standard for Tablets and Capsules (TGO 78). | The products do not meet the assay limits of 92.5-107.5% for the stated content of sevelamer carbonate. | The products conform to the agreed assay titratable amines limit using the agreed assay titratable amines test. The limits to be applied for the content of sevelamer carbonate must be 90.0-110.0 % of labelled claim. | Import and supply | Prescription medicines | |
| Prolastin-C alpha1- proteinase inhibitor (human) 1000 mg powder for injection vial with diluent vial | Grifols Australia Pty Ltd | 234553 | CON-366 | The consent is effective from 6 December 2018 until 7 December 2019. | 6/12/2018 | Subparagraph 3(5)(b)(i) in the Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 | The products do not have the excipients listed on the container. | That the labels to which this consent applies are those specified in the request submitted. | Import and supply | Prescription medicines | |
| ACT-HIB haemophilus type B conjugate vaccine (conjugated to tetanus protein) powder for injection vial and needle free diluent syringe | Sanofi-Aventis Australia Pty Ltd | 130161 | CON-305 | The consent is effective from 10 December 2018 until 1 September 2020. | 10/12/2018 | Paragraph 8(1)(o) of Therapeutic Goods Order No 91 - Standard for labels of prescription and related medicines (TGO 91) | The carton labels for the 1’s and 10’s packs of the product do not have the name of the medicine on at least three non-opposing sides. | The conditions on that consent are as followsNon-compliance with TGO 91 is limited to the information detailed in the submission (PM-2018-04855-1-2)The non-compliant labels will be revised to become fully compliant with TGO 91 on or before 1 September 2020. This exemption applies only to batches released in the Australian market before 1 September 2020 | Import and supply | Prescription medicines | |
| STREPFEN INTENSIVE SUGAR FREE ORANGE flurbiprofen 8.75mg lozenge blister pack (reformulation) | Reckitt Benckiser Pty Ltd | 157020 | DR562 | CON-313 | The consent is effective from 14 December 2018 until 30 April 2019. | 14/12/2018 | Paragraph 7(2)(g) of Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The medicine labels do not include all of the advisory statements required by the Medicines Advisory Statements Specification 2017 (Schedule 2 – RASML No. 4) from 1 January 2019. Themedicine labels do not include the statement “Do not use if trying to become pregnant”. | The labels to which this consent applies are those previously approved for these products, copies of which were provided with the request letter of 22 October 2018. | Import and supply | Over-the-counter medicines |
| NUROFEN FOR CHILDREN 7+ YEARS Orange Flavour ibuprofen 100 mg soft chewable capsules blister pack | Reckitt Benckiser Pty Ltd | 265278 | DL422 DT965 | CON-312 | The consent is effective from 14 December 2018 until 30 June 2019. | 14/12/2018 | Paragraph 7(2)(g) of Therapeutic Goods Order No 69 - General requirements for labels for medicines (TGO 69) | The medicine labels do not include all of the advisory statements required by the Medicines Advisory Statements Specification 2017 (Schedule 2 – RASML No. 4) from 1 January 2019. Themedicine labels do not include the statement “Do not use if trying to become pregnant”. | The labels to which this consent applies are those previously approved for these products, copies of which were provided with the request letter of 30 October 2018. | Import and supply | Over-the-counter medicines |
| NUROFEN FOR CHILDREN BABY 3 MONTHS - 5 YEARS strawberry flavour ibuprofen 100mg/5mL suspension bottle | Reckitt Benckiser Australia Pty Ltd | 118807 | 8263D1 | CON-307 | The consent is effective from 14 December 2018 until 31 March 2019. | 14/12/2018 | Paragraph 9(7)(a) and 9(7)(a)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92) | The font size of the active ingredient on the 50 mL carton and bottle labels are less than the font sizes specified inTGO 92. | Import and supply | Over-the-counter medicines | |
| NUROFEN ZAVANCE LIQUID CAPSULES ibuprofen 200mg soft capsule blister pack | Reckitt Benckiser Pty Ltd | 163477 | DZ740 EM299 | CON-306 | The consent is effective 14 December 2018 until 31 May 2019. | 14/12/2018 | Paragraph 7(2)(g) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The medicine labels do not include all of the advisory statements required by the Medicines Advisory Statements Specification 2017 (Schedule 2 – RASML No.4) from 1 January 2019.Themedicine labels do not include the statement “Do not use if trying to become pregnant”. | The labels to which this consent applies are those previously approved for these products, copies of which were provided with the request letter of 30October 2018. | Import and supply | Over-the-counter medicines |
| Nurofen Caplets ibuprofen 200 mg capsule shaped tablet blister pack | Reckitt Benckiser Pty Ltd | 127287 | DY887 EH323 | CON-306 | The consent is effective 14 December 2018 until 31 May 2019. | 14/12/2018 | Paragraph 7(2)(g) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The medicine labels do not include all of the advisory statements required by the Medicines Advisory Statements Specification 2017 (Schedule 2 – RASML No.4) from 1 January 2019.Themedicine labels do not include the statement “Do not use if trying to become pregnant”. | The labels to which this consent applies are those previously approved for these products, copies of which were provided with the request letter of 30October 2018. | Import and supply | Over-the-counter medicines |
| Nurofen Tablets ibuprofen 200 mg blister pack | Reckitt Benckiser Pty Ltd | 127272 | DW492 | CON-306 | The consent is effective 14 December 2018 until 31 May 2019. | 14/12/2018 | Paragraph 7(2)(g) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The medicine labels do not include all of the advisory statements required by the Medicines Advisory Statements Specification 2017 (Schedule 2 – RASML No.4) from 1 January 2019.Themedicine labels do not include the statement “Do not use if trying to become pregnant”. | The labels to which this consent applies are those previously approved for these products, copies of which were provided with the request letter of 30October 2018. | Import and supply | Over-the-counter medicines |
| Nurofen Zavance 256mg ibuprofen sodium sugar coated capsule shaped tablet blister pack | Reckitt Benckiser Pty Ltd | 156294 | DZ818 EA482 EA640 ED436 | CON-304 | The consent is effective from 14 December 2018 until 30 April 2019. | 14/12/2018 | Paragraph 7(2)(g) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The medicine labels do not include all of the advisory statements required by the Medicines Advisory Statements Specification 2017 (Schedule 2 – RASML No.4) from 1 January 2019.Themedicine labels do not include the statement “Do not use if trying to become pregnant”. | The labels to which this consent applies are those previously approved forthese products, copies of which were provided with the request letter of 19 October 2018. | Import and supply | Over-the-counter medicines |
| Nurofen Zavance 256mg ibuprofen sodium sugar coated capsule shaped tablet blister pack | Reckitt Benckiser Pty Ltd | 156294 | EC132 | CON-304 | The consent is effective from 14 December 2018 until 30 April 2019. | 14/12/2018 | Paragraph 7(2)(g) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The medicine labels do not include all of the advisory statements required by the Medicines Advisory Statements Specification 2017 (Schedule 2 – RASML No.4) from 1 January 2019.Themedicine labels do not include the statement “Do not use if trying to become pregnant”. | The labels to which this consent applies are those previously approved forthese products, copies of which were provided with the request letter of 19 October 2018. | Import and supply | Over-the-counter medicines |
| Nurofen Zavance 256mg ibuprofen sodium sugar coated tablet blister pack | Reckitt Benckiser Pty Ltd | 156293 | EA310 EE867 EH028 EH155 | CON-304 | The consent is effective from 14 December 2018 until 30 April 2019. | 14/12/2018 | Paragraph 7(2)(g) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The medicine labels do not include all of the advisory statements required by the Medicines Advisory Statements Specification 2017 (Schedule 2 – RASML No.4) from 1 January 2019.Themedicine labels do not include the statement “Do not use if trying to become pregnant”. | The labels to which this consent applies are those previously approved forthese products, copies of which were provided with the request letter of 19 October 2018. | Import and supply | Over-the-counter medicines |
| Nurofen Zavance 256mg ibuprofen sodium sugar coated tablet blister pack | Reckitt Benckiser Pty Ltd | 156293 | DX594 EG708 | CON-304 | The consent is effective from 14 December 2018 until 30 April 2019. | 14/12/2018 | Paragraph 7(2)(g) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines | The medicine labels do not include all of the advisory statements required by the Medicines Advisory Statements Specification 2017 (Schedule 2 – RASML No.4) from 1 January 2019.Themedicine labels do not include the statement “Do not use if trying to become pregnant”. | The labels to which this consent applies are those previously approved forthese products, copies of which were provided with the request letter of 19 October 2018. | Import and supply | Over-the-counter medicines |
| CHEMISTS OWN COLD SORE CREAM aciclovir 5% w/w tube | Arrow Pharma Pty Ltd | 106588 | CON-314 | The consent is effective from 17 December 2018 until 31 March 2020. | 17/12/2018 | Section 10 of the Therapeutic Goods Order No 100 Microbiological Standards for Medicines 2018 (TGO 100) - British Pharmacopoeia Test for Efficacy of Antimicrobial Preservation for Aspergillus brasiliensis. | The product does not comply with the acceptance criteria specified in the British Pharmacopoeia Test for Efficacy of Antimicrobial Preservation for Aspergillus brasiliensis. | The product must meet the acceptance criteria for Aspergillus brasiliensis specified in the USP General Chapter lt;51gt; Antimicrobial Effectiveness Testing. | Supply | Over-the-counter medicines | |
| NUROMOL tablet blister pack | Reckitt Benckiser Pty Ltd | 225322 | EH315 EE741 EJ571 EE743 | CON-311 | The consent is effective from 17 December 2018 until 30 April 2019. | 17/12/2018 | Paragraph 7(2)(g) of Therapeutic Goods Order No 69 - General requirements for labels for medicines 2017 (TGO 69) | The medicine labels do not include all of the advisory statements required by the Medicines Advisory Statements Specification 2017 (Schedule 2 – RASML No. 4) from 1 January 2019. Themedicine labels do not include the statement “Do not use if trying to become pregnant”. | The labels to which this consent applies are those previously approved for these products, copies of which were provided with the request letter of 1 November 2018. | Import and supply | Over-the-counter medicines |
| NUROFEN COLD FLU WITH DECONGESTANT tablet blister pack | Reckitt Benckiser Pty Ltd | 65640 | DL738 | CON-309 | The consent is effective from 17 December 2018 until 31 August 2019. | 17/12/2018 | Paragraph 7(2)(g) of Therapeutic Goods Order No. 69 - General requirements for labels for medicines. | The medicine labels do not include all of the advisory statements required by the Medicines Advisory Statements Specification 2017 (Schedule 2 – RASML No.4) from 1 January 2019. Themedicine labels do not include the statement “Do not use if trying to become pregnant”. | The labels to which this consent applies are those previously approved for these products, copies of which were provided with the request letter of 1 November 2018. | Import and supply | Over-the-counter medicines |
| PHARMACY ACTION NASAL DECONGESTANT oxymetazoline hydrochloride 0.5mg/mL spray solution bottle | Generic Health Pty Ltd | 189039 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION HAYFEVER SINUS PAIN RELIEF tablet blister pack | Generic Health Pty Ltd | 189868 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION STOMACH EASE FORTE hyoscine butylbromide 20 mg tablet blister pack | Generic Health Pty Ltd | 216124 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION Heartburn Acid Indigestion Relief ranitidine 150mg tablets (as hydrochloride) blister pack | Generic Health Pty Ltd | 191837 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION Low Dose Aspirin 100mg tablet blister pack | Generic Health Pty Ltd | 190572 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION Heartburn Acid Indigestion Relief Forte ranitidine (as hydrochloride) 300mg tablet blister pack | Generic Health Pty Ltd | 191838 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION NYSTATIN ORAL DROPS 100,000 IU/mL suspension bottle | Generic Health Pty Ltd | 280975 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION DICLOFENAC 25 diclofenac sodium 25 mg tablet | Generic Health Pty Ltd | 293168 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION COLD FLU PSE tablet blister pack | Generic Health Pty Ltd | 295160 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION COLD FLU PE tablet blister pack | Generic Health Pty Ltd | 295510 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION Antiseptic Cream tube | Generic Health Pty Ltd | 193197 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION FemCream clotrimazole 10mg/g cream tube | Generic Health Pty Ltd | 194406 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION COLD FLU RELIEF DAY NIGHT PE tablet blister pack | Generic Health Pty Ltd | 296311 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION COLD FLU DAY NIGHT tablet blister pack | Generic Health Pty Ltd | 294432 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| Pharmacy Action Cold Sore Cream aciclovir 5% tube | Generic Health Pty Ltd | 194405 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION Cold Flu Relief PE blister pack | Generic Health Pty Ltd | 208284 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION Cold Flu Relief PE Day Night tablets blister pack | Generic Health Pty Ltd | 208283 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION HEARTBURN RELIEF pantoprazole 20mg tablets | Generic Health Pty Ltd | 303946 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION SINUS NASAL DECONGESTANT RELIEF tablets blister | Generic Health Pty Ltd | 191938 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION DIARRHOEA PLUS GAS RELIEF chewable tablet blister | Generic Health Pty Ltd | 279728 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION Cetrelief cetirizine hydrochloride 10mg tablet blister | Generic Health Pty Ltd | 190243 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION Paracetamol 500mg tablet blister pack | Generic Health Pty Ltd | 192004 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION FEXORELIEF 180 tablet blister pack | Generic Health Pty Ltd | 233592 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION FEXORELIEF tablet blister pack | Generic Health Pty Ltd | 233591 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION CHESTY COUGH RELIEF oral liquid bottle | Generic Health Pty Ltd | 198702 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION Hayfever Sinus Pain Relief PE tablets blister pack | Generic Health Pty Ltd | 191939 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION LORASTYNE loratadine 10mg tablets blister pack | Generic Health Pty Ltd | 191959 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION COLD ASSIST tablet blister pack | Generic Health Pty Ltd | 230095 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| PHARMACY ACTION Diarrhoea Relief loperamide hydrochloride 2mg capsule | Generic Health Pty Ltd | 191154 | CON-308 | 17 December 2018 until 31 August 2020. | 17/12/2018 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 (TGO 69) | The products do not comply because the labels display the previous address of the sponsor instead of displaying the address for the new premises the sponsor has moved into. | Import and supply | Over-the-counter medicines | ||
| NUROFEN COLD FLU PE tablets blister pack | Reckitt Benckiser Pty Ltd | 181936 | DR505 EA487 DR504 DV117 DZ928 DM898 DX612 | CON-310 | The consent is effective from 18 December 2018 until 31 May 2019. | 18/12/2018 | Paragraph 7(2)(g) of Therapeutic Goods Order No 69 - General requirements for labels for medicines 2017 (TGO 69) | The medicine labels do not include all of the advisory statements required by the Medicines Advisory Statements Specification 2017 (Schedule 2 – RASML No. 4) from 1 January 2019.The medicine labels do not include the statement “Do not use if trying to become pregnant”. | The labels to which this consent applies are those previously approved for these products, copies of which were provided with the request letter of 1 November 2018. | Import and supply | Over-the-counter medicines |
| Nyxoid naloxone hydrochloride dihydrate 2.2 mg/actuation nasal spray vial | Mundipharma Pty Ltd | 309381 | MNXA1802B | CON-316 | The consent is effective from 2 January 2019 until 18 October 2020. | 2/01/2019 | Paragraph 7(2)(b) and 7(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines (TGO 69) | The container and blister labels do not specify the AAN of the active ingredient and the Australian sponsor details. | Import and supply | Over-the-counter medicines | |
| NICOTINELL PEPPERMINT LOZENGES nicotine (as nicotine polacrilex) 4 mg lozenge blister pack | Orion Laboratories Pty Ltd T/A Perrigo Australia | 276926 | 8HW0158 | CON-315 | The consent is effective from 7 January 2019 until 31 July 2020. | 7/01/2019 | Subparagraph 10(9)(a)(v) of the Therapeutic Goods Order No 92 – Standard for labels of non-prescription medicines (TGO 92). | The foil labels do not include the full Australian Approved Name (AAN) of the active ingredient. | Import and supply | Over-the-counter medicines | |
| NICOTINELL PEPPERMINT LOZENGES nicotine (as nicotine polacrilex) 2 mg lozenge blister pack | Orion Laboratories Pty Ltd T/A Perrigo Australia | 276925 | 8JW0031 | CON-315 | The consent is effective from 7 January 2019 until 31 July 2020. | 7/01/2019 | Subparagraph 10(9)(a)(v) of the Therapeutic Goods Order No 92 – Standard for labels of non-prescription medicines (TGO 92). | The foil labels do not include the full Australian Approved Name (AAN) of the active ingredient. | Import and supply | Over-the-counter medicines | |
| APO-NICORANDIL nicorandil 10 mg tablet blister pack | Apotex Pty Ltd | 277346 | CON-318 | The consent is effective from 8 January 2019 until 8 January 2021. | 8/01/2019 | Paragraph 8 of the Therapeutic Goods Order No. 78 - Standard for tablets and capsules (TGO 78) - the products do not conform with the British Pharmacopoeia Monograph for Nicorandil Tablets, specifically the expiry limit for the assay. | The expiry limit for the assay is 92.5% -105.0% where the British Pharmacopoeia Monograph for Nicorandil tablets requires 95.0%-105.0%. | The expiry limits are those currently approved and meet the default assay requirements of TGO 78, that is 92.5% - 105.0%. | Import and supply | Prescription medicines | |
| NICORANDIL APOTEX nicorandil 20 mg tablet blister pack | Apotex Pty Ltd | 277345 | CON-318 | The consent is effective from 8 January 2019 until 8 January 2021. | 8/01/2019 | Paragraph 8 of the Therapeutic Goods Order No. 78 - Standard for tablets and capsules (TGO 78) - the products do not conform with the British Pharmacopoeia Monograph for Nicorandil Tablets, specifically the expiry limit for the assay. | The expiry limit for the assay is 92.5% -105.0% where the British Pharmacopoeia Monograph for Nicorandil tablets requires 95.0%-105.0%. | The expiry limits are those currently approved and meet the default assay requirements of TGO 78, that is 92.5% - 105.0%. | Import and supply | Prescription medicines | |
| NICORANDIL APOTEX nicorandil 10 mg tablet blister pack | Apotex Pty Ltd | 277344 | CON-318 | The consent is effective from 8 January 2019 until 8 January 2021. | 8/01/2019 | Paragraph 8 of the Therapeutic Goods Order No. 78 - Standard for tablets and capsules (TGO 78) - the products do not conform with the British Pharmacopoeia Monograph for Nicorandil Tablets, specifically the expiry limit for the assay. | The expiry limit for the assay is 92.5% -105.0% where the British Pharmacopoeia Monograph for Nicorandil tablets requires 95.0%-105.0%. | The expiry limits are those currently approved and meet the default assay requirements of TGO 78, that is 92.5% - 105.0%. | Import and supply | Prescription medicines | |
| APO-NICORANDIL nicorandil 20 mg tablet blister pack | Apotex Pty Ltd | 277343 | CON-318 | The consent is effective from 8 January 2019 until 8 January 2021. | 8/01/2019 | Paragraph 8 of the Therapeutic Goods Order No. 78 - Standard for tablets and capsules (TGO 78) - the products do not conform with the British Pharmacopoeia Monograph for Nicorandil Tablets, specifically the expiry limit for the assay. | The expiry limit for the assay is 92.5% -105.0% where the British Pharmacopoeia Monograph for Nicorandil tablets requires 95.0%-105.0%. | The expiry limits are those currently approved and meet the default assay requirements of TGO 78, that is 92.5% - 105.0%. | Import and supply | Prescription medicines | |
| CYSTADANE betaine 1g/g oral powder bottle | Recordati Rare Diseases Australia Pty Ltd | 57379 | CON-317 | The consent is effective from 8 January 2019 until 8 January 2020. | 8/01/2019 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69). | The product does not comply because the labels display the name and address of the previous sponsor (Emerge Health, Suite 3, Level 1, 2 Theatre Place, Canterbury VIC 3126) instead of displaying the name and address of the current sponsor of the product (Recordati Rare Diseases Australia Pty Ltd, Level 6, 69 Reservoir Street, Surry Hills, NSW 2010). | Supply | Over-the-counter medicines | ||
| TYGACYCLINE tigecycline 50 mg Powder for injection Glass vial | Neo Health (Australia) Pty Ltd | 275814 | CON-339 | The consent is effective from 18 January 2019 until 17 January 2020. | 18/01/2019 | The requirements of the United States Pharmacopeia -National Formulary (USP) monograph Tigecycline for Injection. | The productsdo not conform to the requirements of the USP monograph for Tigecycline for Injection, in respect to expiry limit for tigecycline epimer. | The products comply with the USP monograph for Tigecycline for Injection except for the tigecycline epimer impurity, for which the expiry limit of NMT 2.5% applies. During these 12 months, if the United States Pharmacopeia will not widen the limit for tigecycline epimer, other steps (eg. reduction of shelf life, manufacturing improvements, etc.) should be taken to ensure that after this 12 month period, the monograph limit of NMT 2.0% is met at expiry. | Import and supply | Prescription medicines | |
| TYGALINE tigecycline 50 mg Powder for injection Glass vial | Neo Health (Australia) Pty Ltd | 275813 | CON-339 | The consent is effective from 18 January 2019 until 17 January 2020. | 18/01/2019 | The requirements of the United States Pharmacopeia -National Formulary (USP) monograph Tigecycline for Injection. | The productsdo not conform to the requirements of the USP monograph for Tigecycline for Injection, in respect to expiry limit for tigecycline epimer. | The products comply with the USP monograph for Tigecycline for Injection except for the tigecycline epimer impurity, for which the expiry limit of NMT 2.5% applies. During these 12 months, if the United States Pharmacopeia will not widen the limit for tigecycline epimer, other steps (eg. reduction of shelf life, manufacturing improvements, etc.) should be taken to ensure that after this 12 month period, the monograph limit of NMT 2.0% is met at expiry. | Import and supply | Prescription medicines | |
| TIGECYCLE tigecycline 50 mg Powder for injection Glass vial | Neo Health (Australia) Pty Ltd | 275812 | CON-339 | The consent is effective from 18 January 2019 until 17 January 2020. | 18/01/2019 | The requirements of the United States Pharmacopeia -National Formulary (USP) monograph Tigecycline for Injection. | The productsdo not conform to the requirements of the USP monograph for Tigecycline for Injection, in respect to expiry limit for tigecycline epimer. | The products comply with the USP monograph for Tigecycline for Injection except for the tigecycline epimer impurity, for which the expiry limit of NMT 2.5% applies. During these 12 months, if the United States Pharmacopeia will not widen the limit for tigecycline epimer, other steps (eg. reduction of shelf life, manufacturing improvements, etc.) should be taken to ensure that after this 12 month period, the monograph limit of NMT 2.0% is met at expiry. | Import and supply | Prescription medicines | |
| Blood and blood components | Australian Red Cross Blood Service | N/A | CON-319 | The consent is effective from 25 January 2019 until the specified conditions no longer remain true | 25/01/2019 | The product does not comply with the deferral requirements for donors with severe cardiac arrhythmia outlined in Therapeutic Goods Order No. 81 - Standards for Blood and Blood Components (TGO 81) - Council of Europe Guide to the preparation, use and quality assurance of blood components (18th edition) (CoE Guide) | People who have a history of severe cardiac arrhythmia can be accepted as blood donors if they meet the new criteria detailed in the Updated Arrhythmias Guidelines in the Guidelines for Selection of Blood Donors (GSBD) | Should new information becomes available in the future, indicating that the blood donation is having a negative impact on the health and safety of patients with a history of arrhythmias, the Australian Red Cross Blood Service (ARCBS) must submit this information to the TGA and obtain approval to continue with this exemption. | Supply | Blood, tissues, and biologicals | |
| Ganoderma Lucidum Complex capsule | HEC Group Pty Ltd | 289420 | 11845 | CON-320 | The consent is effective from 4 February 2019 until 10 January 2020 | 4/02/2019 | The product does not comply with the Uniformity of Weight (Mass) requirements of Appendix XII C of the British Pharmacopoeia (BP) - Subsection 10(a) of the Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules (TGO 78) | The product does not complybecause there is a low bulk density of fine powder currently being used in the manufacture of the capsules. As a result the uniformity of weight of 3 individual capsules (out of 20 capsules) was found to be more than the acceptable BP range of +/-7.5%. | The exemption applies only to the particular batch 11845 of the product | Supply and export | Over-the-counter medicines |
| NOVICRIT epoetin lambda (rch) 10,000 IU/1.0 mL solution for injection syringe | Sandoz Pty Ltd | 147842 | CON-364 | The consent is effective from 8 February 2019 until further notice. | 8/02/2019 | European Pharmacopoeia Monograph for ‘Erythropoetin concentrated solution’ (Ph. Eur. ). | The products will not have the residual DNA test included in their Drug Substance or Drug Product specifications. | The products to which this consent applies are those specified in the request submitted. | Import and supply | Prescription medicines | |
| NOVICRIT epoetin lambda (rch) 9,000 IU/0.9 mL solution for injection syringe | Sandoz Pty Ltd | 147838 | CON-364 | The consent is effective from 8 February 2019 until further notice. | 8/02/2019 | European Pharmacopoeia Monograph for ‘Erythropoetin concentrated solution’ (Ph. Eur. ). | The products will not have the residual DNA test included in their Drug Substance or Drug Product specifications. | The products to which this consent applies are those specified in the request submitted. | Import and supply | Prescription medicines | |
| NOVICRIT epoetin lambda (rch) 8,000 IU/0.8 mL solution for injection syringe | Sandoz Pty Ltd | 147837 | CON-364 | The consent is effective from 8 February 2019 until further notice. | 8/02/2019 | European Pharmacopoeia Monograph for ‘Erythropoetin concentrated solution’ (Ph. Eur. ). | The products will not have the residual DNA test included in their Drug Substance or Drug Product specifications. | The products to which this consent applies are those specified in the request submitted. | Import and supply | Prescription medicines | |
| NOVICRIT epoetin lambda (rch) 7,000 IU/0.7 mL solution for injection syringe | Sandoz Pty Ltd | 147835 | CON-364 | The consent is effective from 8 February 2019 until further notice. | 8/02/2019 | European Pharmacopoeia Monograph for ‘Erythropoetin concentrated solution’ (Ph. Eur. ). | The products will not have the residual DNA test included in their Drug Substance or Drug Product specifications. | The products to which this consent applies are those specified in the request submitted. | Import and supply | Prescription medicines | |
| NOVICRIT epoetin lambda (rch) 6,000 IU/0.6 mL solution for injection syringe | Sandoz Pty Ltd | 147844 | CON-364 | The consent is effective from 8 February 2019 until further notice. | 8/02/2019 | European Pharmacopoeia Monograph for ‘Erythropoetin concentrated solution’ (Ph. Eur. ). | The products will not have the residual DNA test included in their Drug Substance or Drug Product specifications. | The products to which this consent applies are those specified in the request submitted. | Import and supply | Prescription medicines | |
| NOVICRIT epoetin lambda (rch) 5,000 IU/0.5 mL solution for injection syringe | Sandoz Pty Ltd | 147859 | CON-364 | The consent is effective from 8 February 2019 until further notice. | 8/02/2019 | European Pharmacopoeia Monograph for ‘Erythropoetin concentrated solution’ (Ph. Eur. ). | The products will not have the residual DNA test included in their Drug Substance or Drug Product specifications. | The products to which this consent applies are those specified in the request submitted. | Import and supply | Prescription medicines | |
| NOVICRIT epoetin lambda (rch) 4,000 IU/0.4 mL solution for injection syringe | Sandoz Pty Ltd | 147843 | CON-364 | The consent is effective from 8 February 2019 until further notice. | 8/02/2019 | European Pharmacopoeia Monograph for ‘Erythropoetin concentrated solution’ (Ph. Eur. ). | The products will not have the residual DNA test included in their Drug Substance or Drug Product specifications. | The products to which this consent applies are those specified in the request submitted. | Import and supply | Prescription medicines | |
| NOVICRIT epoetin lambda (rch) 3,000 IU/0.3 mL solution for injection syringe | Sandoz Pty Ltd | 147849 | CON-364 | The consent is effective from 8 February 2019 until further notice. | 8/02/2019 | European Pharmacopoeia Monograph for ‘Erythropoetin concentrated solution’ (Ph. Eur. ). | The products will not have the residual DNA test included in their Drug Substance or Drug Product specifications. | The products to which this consent applies are those specified in the request submitted. | Import and supply | Prescription medicines | |
| NOVICRIT epoetin lambda (rch) 2,000 IU/1.0 mL solution for injection syringe | Sandoz Pty Ltd | 147833 | CON-364 | The consent is effective from 8 February 2019 until further notice. | 8/02/2019 | European Pharmacopoeia Monograph for ‘Erythropoetin concentrated solution’ (Ph. Eur. ). | The products will not have the residual DNA test included in their Drug Substance or Drug Product specifications. | The products to which this consent applies are those specified in the request submitted. | Import and supply | Prescription medicines | |
| NOVICRIT epoetin lambda (rch) 1,000 IU/0.5 mL solution for injection syringe | Sandoz Pty Ltd | 147847 | CON-364 | The consent is effective from 8 February 2019 until further notice. | 8/02/2019 | European Pharmacopoeia Monograph for ‘Erythropoetin concentrated solution’ (Ph. Eur. ). | The products will not have the residual DNA test included in their Drug Substance or Drug Product specifications. | The products to which this consent applies are those specified in the request submitted. | Import and supply | Prescription medicines | |
| DILANTIN PAEDIATRIC SUSPENSION phenytoin 30mg/5mL oral liquid bottle | Pfizer Australia Pty Ltd | 14309 | 0L5679 0L5680 | CON-321 | The consent is effective from 8 February 2019 until the batches are exhausted. | 8/02/2019 | General requirements for Elemental Impurities of the British Pharmacopoeia (BP) or United States Pharmacopeia (USP) - International Conference on Harmonisation (ICH) Q3D Guideline on Elemental Impurities. | Lithium and lead levels in excess of the ICH Q3D permitted daily exposure limits when dosed to patients with higher body weights (e.g. adults). | 1. A ‘Dear Healthcare Provider’ letter identical to that provided by the TGA on 6 February 2019 will be supplied explaining the issues surrounding the products and safe dosing levels for patients. 2. The Dear Healthcare provider letter will be distributed with the affected batches as proposed in Pfizer’s communication with the TGA on 5 February 2019. | Import and supply | Prescription medicines |
| CYCLOGYL cyclopentolate hydrochloride 1% eye drops bottle | Alcon Laboratories Australia Pty Ltd | AUST R 25273 | CON-574 | The consent is effective for all batches manufactured from 13 February 2019 until 31 August 2020. | 13/02/2019 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The labels include the old company address at 'Frenchs Forest NSW 2086'. | The labels to which this consent applies are those approved prior to the variation granted 16 February 2017 and the sponsor maintains a mail forwarding service from the old address for the duration of this consent. | Import and supply | Prescription medicines | |
| PHARMACY ACTION PARACETAMOL IBUPROFEN film coated tablet blister pack | Generic Health Pty Ltd | 281501 | 830990 830564 | CON-323 | The consent is effective from 15 February 2019 until the expiry date of the respective batches - 830990 (expiry date 08/2020) and 830564 (expiry date 05/2020). | 15/02/2019 | Paragraphs 7(2)(g) and 7(2)(l) of the Therapeutic Goods Order No. 69 - General Requirements for Labels for Medicines 2017 (TGO 69). | The label does not contain the name and contact details of the current sponsor and the advisory statement quot;do not use if trying to become pregnantquot;. It is noted that the medicine label does contain the other pregnancy advisory statement quot;Do not take if you are pregnantquot;. | The product in relation to which this consent is given must comply with all other applicable parts of the TGO 69 and other applicable standards. | Supply | Over-the-counter medicines |
| Wellgrove Heart Health Mint Flavour | Boundary Bend Wellness Ltd | 312834 | CON-322 | The consent is effective from 15 February 2019 until 8 February 2020. | 15/02/2019 | Preservative efficacy test acceptance criteria outlined in the British Pharmacopoeia, Appendix XVI C, Criteria B (Table 5.1.3.3), as mandated by Section 10 of the Therapeutic Goods Order No. 100 – Microbiological Standards for Medicines (TGO 100) | The product does not comply with the prescribed requirements of the British Pharmacopoeia preservative efficacy test acceptance criteria.The non-compliance is only applicable for the fungiAspergillus brasiliensiswhere1 log reduction at 14 days was not observed with no increase in the number of viable micro-organisms at 28 days. | The sponsor/manufacturer will continue to investigate and monitor the market place for quality and to minimise risk. The products in relation to which this consent is given must comply with all other applicable parts of the TGO 100 and all other applicable standards. | Supply | Listed complementary medicines | |
| Wellgrove Heart Health Natural Flavour | Boundary Bend Wellness Ltd | 312833 | CON-322 | The consent is effective from 15 February 2019 until 8 February 2020. | 15/02/2019 | Preservative efficacy test acceptance criteria outlined in the British Pharmacopoeia, Appendix XVI C, Criteria B (Table 5.1.3.3), as mandated by Section 10 of the Therapeutic Goods Order No. 100 – Microbiological Standards for Medicines (TGO 100) | The product does not comply with the prescribed requirements of the British Pharmacopoeia preservative efficacy test acceptance criteria.The non-compliance is only applicable for the fungiAspergillus brasiliensiswhere1 log reduction at 14 days was not observed with no increase in the number of viable micro-organisms at 28 days. | The sponsor/manufacturer will continue to investigate and monitor the market place for quality and to minimise risk. The products in relation to which this consent is given must comply with all other applicable parts of the TGO 100 and all other applicable standards. | Supply | Listed complementary medicines | |
| Wellgrove Immune Support Green Apple Flavour | Boundary Bend Wellness Ltd | 312529 | CON-322 | The consent is effective from 15 February 2019 until 8 February 2020. | 15/02/2019 | Preservative efficacy test acceptance criteria outlined in the British Pharmacopoeia, Appendix XVI C, Criteria B (Table 5.1.3.3), as mandated by Section 10 of the Therapeutic Goods Order No. 100 – Microbiological Standards for Medicines (TGO 100) | The product does not comply with the prescribed requirements of the British Pharmacopoeia preservative efficacy test acceptance criteria.The non-compliance is only applicable for the fungiAspergillus brasiliensiswhere1 log reduction at 14 days was not observed with no increase in the number of viable micro-organisms at 28 days. | The sponsor/manufacturer will continue to investigate and monitor the market place for quality and to minimise risk. The products in relation to which this consent is given must comply with all other applicable parts of the TGO 100 and all other applicable standards. | Supply | Listed complementary medicines | |
| Wellgrove Immune Support Berry Flavour | Boundary Bend Wellness Ltd | 312530 | CON-322 | The consent is effective from 15 February 2019 until 8 February 2020. | 15/02/2019 | Preservative efficacy test acceptance criteria outlined in the British Pharmacopoeia, Appendix XVI C, Criteria B (Table 5.1.3.3), as mandated by Section 10 of the Therapeutic Goods Order No. 100 – Microbiological Standards for Medicines (TGO 100) | The product does not comply with the prescribed requirements of the British Pharmacopoeia preservative efficacy test acceptance criteria.The non-compliance is only applicable for the fungiAspergillus brasiliensiswhere1 log reduction at 14 days was not observed with no increase in the number of viable micro-organisms at 28 days. | The sponsor/manufacturer will continue to investigate and monitor the market place for quality and to minimise risk. The products in relation to which this consent is given must comply with all other applicable parts of the TGO 100 and all other applicable standards. | Supply | Listed complementary medicines | |
| Wellgrove Immune Support Natural Flavour | Boundary Bend Wellness Ltd | 312527 | CON-322 | The consent is effective from 15 February 2019 until 8 February 2020. | 15/02/2019 | Preservative efficacy test acceptance criteria outlined in the British Pharmacopoeia, Appendix XVI C, Criteria B (Table 5.1.3.3), as mandated by Section 10 of the Therapeutic Goods Order No. 100 – Microbiological Standards for Medicines (TGO 100) | The product does not comply with the prescribed requirements of the British Pharmacopoeia preservative efficacy test acceptance criteria.The non-compliance is only applicable for the fungiAspergillus brasiliensiswhere1 log reduction at 14 days was not observed with no increase in the number of viable micro-organisms at 28 days. | The sponsor/manufacturer will continue to investigate and monitor the market place for quality and to minimise risk. The products in relation to which this consent is given must comply with all other applicable parts of the TGO 100 and all other applicable standards. | Supply | Listed complementary medicines | |
| NPLATE romiplostim (rbe) 625 microgram powder for injection vial | Amgen Australia Pty Ltd | 283890 | CON-363 | The consent is effective from 12 March 2019 until further notice. | 12/03/2019 | Subparagraph 11(2)(f)(i) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines. | The product labels do not express the quantity of active as the stated weight of active ingredient of the vial. Instead, the quantity of active ingredient is expressed in terms of concentration. | The products to which this consent applies are those specified in the request submitted. | Import and supply | Prescription medicines | |
| NPLATE romiplostim (rbe) 625 microgram powder for injection vial | Amgen Australia Pty Ltd | 147188 | CON-363 | The consent is effective from 12 March 2019 until further notice. | 12/03/2019 | Subparagraph 11(2)(f)(i) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines. | The product labels do not express the quantity of active as the stated weight of active ingredient of the vial. Instead, the quantity of active ingredient is expressed in terms of concentration. | The products to which this consent applies are those specified in the request submitted. | Import and supply | Prescription medicines | |
| NPLATE romiplostim (rbe) 375 microgram powder for injection vial | Amgen Australia Pty Ltd | 147187 | CON-363 | The consent is effective from 12 March 2019 until further notice. | 12/03/2019 | Subparagraph 11(2)(f)(i) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines. | The product labels do not express the quantity of active as the stated weight of active ingredient of the vial. Instead, the quantity of active ingredient is expressed in terms of concentration. | The products to which this consent applies are those specified in the request submitted. | Import and supply | Prescription medicines | |
| FIASP FLEXTOUCH insulin aspart (rys) 100 units/mL solution for injection 3 mL pre-filled pen | Novo Nordisk Pharmaceuticals Pty Ltd | 275394 | CON-324 | The consent is effective from 15 March 2019 until further notice. | 15/03/2019 | Subparagraph 10(3)(a)(iii) of the Therapeutic Goods Order No 91 - Standard for labels of prescription and related medicines (TGO 91). | The primary pack and carton do not express the quantity of each excipient in the medicine. | The products to which this consent applies are those specified in the request submitted. | Import and supply | Prescription medicines | |
| FIASP PENFILL insulin aspart (rys) 100 units/mL solution for injection 3 mL cartridge | Novo Nordisk Pharmaceuticals Pty Ltd | 275393 | CON-324 | The consent is effective from 15 March 2019 until further notice. | 15/03/2019 | Subparagraph 10(3)(a)(iii) of the Therapeutic Goods Order No 91 - Standard for labels of prescription and related medicines (TGO 91). | The primary pack and carton do not express the quantity of each excipient in the medicine. | The products to which this consent applies are those specified in the request submitted. | Import and supply | Prescription medicines | |
| FIASP insulin aspart (rys) 100 units/mL solution for injection 10 mL vial | Novo Nordisk Pharmaceuticals Pty Ltd | 275375 | CON-324 | The consent is effective from 15 March 2019 until further notice. | 15/03/2019 | Subparagraph 10(3)(a)(iii) of the Therapeutic Goods Order No 91 - Standard for labels of prescription and related medicines (TGO 91). | The primary pack and carton do not express the quantity of each excipient in the medicine. | The products to which this consent applies are those specified in the request submitted. | Import and supply | Prescription medicines | |
| NYAL ANTIVIRAL COLD SORE cream aciclovir 50mg/g tube | iNova Pharmaceuticals (Australia) Pty Ltd | 147218 | CON-325 | The consent is effective from 20 March 2019 until 31 August 2020. | 20/03/2019 | Section 10 of the Therapeutic Goods Order No. 100 Microbiological Standards for Medicines 2018 (TGO 100) - British Pharmacopoeia Test for Efficacy of Antimicrobial Preservation for Aspergillus brasiliensis. | The product does not comply with the acceptance criteria specified in the British Pharmacopoeia Test for Efficacy of Antimicrobial Preservation for Aspergillus brasiliensis. | The product must meet the acceptance criteria for Aspergillus brasiliensis specified in the USP General Chapter lt;51gt;Antimicrobial Effectiveness Testing. | Supply | Over-the-counter medicines | |
| PHARMACY ACTION FEXORELIEF 180 fexofenadine hydrochloride 180 mg film coated tablet blister pack (new formulation) | Generic Health Pty Ltd | 233592 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| PHARMACY ACTION FEXORELIEF 120 fexofenadine hydrochloride 120 mg film coated tablet blister pack (new formulation) | Generic Health Pty Ltd | 233591 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| PHARMACY ACTION COLD ASSIST paracetamol 500 mg and chlorpheniramine 2 mg tablet blister pack | Generic Health Pty Ltd | 230095 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| ANASTROZOLE GENERICHEALTH anastrozole 1 mg tablet blister pack | Generic Health Pty Ltd | 206404 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| PHARMACY ACTION CHESTY COUGH RELIEF bromhexine hydrochloride 1.6mg/mL oral liquid bottle | Generic Health Pty Ltd | 198702 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| PHARMACY ACTION Paracetamol 500mg tablet blister pack | Generic Health Pty Ltd | 192004 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| PHARMACY ACTION LORASTYNE loratadine 10mg tablets blister pack | Generic Health Pty Ltd | 191959 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| PHARMACY ACTION Hayfever Sinus Pain Relief PE tablets blister pack | Generic Health Pty Ltd | 191939 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| PHARMACY ACTION Diarrhoea Relief loperamide hydrochloride 2mg capsule blister pack | Generic Health Pty Ltd | 191154 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| PHARMACY ACTION Cetrelief cetirizine hydrochloride 10mg tablet blister pack | Generic Health Pty Ltd | 190243 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| LETROZOLE GENERICHEALTH letrozole 2.5mg tablet blister pack | Generic Health Pty Ltd | 176278 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| CLOPIDOGREL GH clopidogrel (as besilate) 75mg film-coated tablet blister pack | Generic Health Pty Ltd | 164870 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| OCTREOTIDE-MAXRX octreotide as acetate 50 micrograms/1 mL injection ampoule | Generic Health Pty Ltd | 148404 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| OCTREOTIDE-MAXRX octreotide as acetate 500 micrograms/1 mL injection ampoule | Generic Health Pty Ltd | 148403 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| ENALAPRIL GENERIC HEALTH enalapril maleate 20mg tablet blister pack | Generic Health Pty Ltd | 142951 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| ENALAPRIL GENERIC HEALTH enalapril maleate 10mg tablet blister pack | Generic Health Pty Ltd | 142950 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| ENALAPRIL GENERIC HEALTH enalapril maleate 5mg tablet blister pack | Generic Health Pty Ltd | 142949 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| QUINAPRIL GENERIC HEALTH quinapril 20mg (as hydrochloride) tablets blister pack | Generic Health Pty Ltd | 133201 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| ALENDROBELL 70mg alendronic acid 70mg (as sodium alendronate anhydrous) tablet blister pack | Generic Health Pty Ltd | 130163 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| CIPROFLOXACIN-BW ciprofloxacin 500mg (as hydrochloride monohydrate) tablet blister pack | Generic Health Pty Ltd | 127781 | CON-327 | The consent is effective from 22 March 2019 until the labels are updated to the newer labelling Order (TGO 91) or 1 September 2020, whichever occurs first. | 22/03/2019 | Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017. | The labels do not state the current address of the sponsor. | The labels to which this consent applies are those currently approved with the sponsor’s former address stated and that arrangements are in place to redirect any mailed correspondence. | Import and supply | Prescription medicines | |
| EllaOne ulipristal acetate 30 mg tablet blister pack | Brand Solutions Australia | 219535 | ED077A | CON-326 | The consent is effective from 22 March 2019 until 22 March 2020. | 22/03/2019 | Paragraph 7(2)(l) of the Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69). | The product does not comply because the labels display the name and address of the previous sponsor (MS Health Pty Ltd, Suite 60, 278 Church Street, Richmond VIC 3121) instead of displaying the name and address of the current sponsor of the product (Brand Solutions Australia, Suite 72, Level 3, Building 2, 574 Plummer Street, Port Melbourne VIC 3207). | Supply | Over-the-counter medicines | |
| Microgenics Calcium Complete | RF Six Pty Ltd | 309330 | Q8237G Q8240G | CON-328 | The consent is effective from 5 April 2019. | 5/04/2019 | Schedule 2 of the Therapeutic Goods Standard for Tablets, Capsules and Pills (TGO101) Order 2019 relating to assay limits for boron content. | The batchesdo not conform to the Schedule 2 requirements of the TGO101 for boron content as it does not comply with the upper limit of 125% of the stated content for an active ingredient. | The content of boron must be no less than 90% and no more than 160% overage of the stated content on the label.Any future s14 exemption applications from the same sponsor regarding the same product with the same issue will require major justifications. | Supply | Listed complementary medicines |
| MULTI VITAMINS MINERALS | Australian Naturalcare Products Pty Ltd | 130777 | 81133 | CON-329 | The consent is effective from 18 April 2019. | 18/04/2019 | Section 14(2) of the Therapeutic Goods (Standards for Tablets, Capsules and Pills) (TGO101) Order 2019 for an active ingredient included in a group of Schedule 2 of this Order. | The batch does not conform to the Schedule 2 requirements of TGO 101 for retinyl acetate as it does not comply with the upper limit of 165.0% of the stated content for an active ingredient. | The content of retinyl acetate must be no less than 90 % and no more than 174 % of the stated content on the label. | Supply | Listed complementary medicines |
| NITYR nitisinone 5 mg tablet bottle | Orpharma Pty Ltd | 288128 | CON-330 | The consent is effective from 23 April 2019 until 23 April 2021. | 23/04/2019 | Subsections 8(2), 9(3) and 11(5) and paragraphs 8(1)(j), (k), (o) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | The carton labels do not state all relevant warning statements (signal headings), substances (excipients) with known effect (for lactose and sugars), the trade name is not repeated on 3 non-opposing sides, space for a dispensing label is not included, the name and quantity of the active ingredient are not placed on the same line immediately underneath the trade name and the permitted storage conditions are not stated.The bottle labels do not state all relevant warning statements (signal headings), substances (excipients) with known effect (for lactose and sugars), the name and quantity of the active ingredient are not placed on the same line immediately underneath the trade name and the permitted storage conditions are not stated. | The labels to which this consent applies are those provided with your letter of application and are overstickered with the Australian sponsor's details and the AUST R numbers as indicated. A 'Dear Healthcare Professional' letter identical to that provided to the TGA on 16 April 2019 advising of the labelling differences and the Australian approved handling and storage conditions, must be provided with each of the affected batches. A copy of the Australian approved Product Information document will accompany each 'Dear Healthcare Professional' letter. | Import and supply | Prescription medicines | |
| NITYR nitisinone 2 mg tablet bottle | Orpharma Pty Ltd | 288127 | CON-330 | The consent is effective from 23 April 2019 until 23 April 2021. | 23/04/2019 | Subsections 8(2), 9(3) and 11(5) and paragraphs 8(1)(j), (k), (o) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | The carton labels do not state all relevant warning statements (signal headings), substances (excipients) with known effect (for lactose and sugars), the trade name is not repeated on 3 non-opposing sides, space for a dispensing label is not included, the name and quantity of the active ingredient are not placed on the same line immediately underneath the trade name and the permitted storage conditions are not stated.The bottle labels do not state all relevant warning statements (signal headings), substances (excipients) with known effect (for lactose and sugars), the name and quantity of the active ingredient are not placed on the same line immediately underneath the trade name and the permitted storage conditions are not stated. | The labels to which this consent applies are those provided with your letter of application and are overstickered with the Australian sponsor's details and the AUST R numbers as indicated. A 'Dear Healthcare Professional' letter identical to that provided to the TGA on 16 April 2019 advising of the labelling differences and the Australian approved handling and storage conditions, must be provided with each of the affected batches. A copy of the Australian approved Product Information document will accompany each 'Dear Healthcare Professional' letter. | Import and supply | Prescription medicines | |
| NITYR nitisinone 10 mg tablet bottle | Orpharma Pty Ltd | 288126 | CON-330 | The consent is effective from 23 April 2019 until 23 April 2021. | 23/04/2019 | Subsections 8(2), 9(3) and 11(5) and paragraphs 8(1)(j), (k), (o) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | The carton labels do not state all relevant warning statements (signal headings), substances (excipients) with known effect (for lactose and sugars), the trade name is not repeated on 3 non-opposing sides, space for a dispensing label is not included, the name and quantity of the active ingredient are not placed on the same line immediately underneath the trade name and the permitted storage conditions are not stated.The bottle labels do not state all relevant warning statements (signal headings), substances (excipients) with known effect (for lactose and sugars), the name and quantity of the active ingredient are not placed on the same line immediately underneath the trade name and the permitted storage conditions are not stated. | The labels to which this consent applies are those provided with your letter of application and are overstickered with the Australian sponsor's details and the AUST R numbers as indicated. A 'Dear Healthcare Professional' letter identical to that provided to the TGA on 16 April 2019 advising of the labelling differences and the Australian approved handling and storage conditions, must be provided with each of the affected batches. A copy of the Australian approved Product Information document will accompany each 'Dear Healthcare Professional' letter. | Import and supply | Prescription medicines | |
| FABRAZYME agalsidase beta - rch 5.5 mg powder for injection vial | Sanofi-Aventis Australia Pty Ltd | 94000 | CON-361 | The consent is effective from 30 April 2019 until 29 April 2021 | 30/04/2019 | Paragraph 7(2)(l) in the Therapeutic Goods Order No. 69 – General requirements for labels for medicines 2017. | The labels for the products do not include the name and address of the current sponsor | The labels to which this consent applies are those previously approved for the former sponsor Genzyme Australia Pty Ltd. Further, arrangements are in place with the former sponsor. Genzyme Australia Pty Ltd, for prompt referral of any queries or complaints concerning the products to the Sanofi-Aventis Australia Ltd. | Import and supply | Prescription medicines | |
| FABRAZYME agalsidase beta-rch 35 mg powder for injection vial | Sanofi-Aventis Australia Pty Ltd | 82755 | CON-361 | The consent is effective from 30 April 2019 until 29 April 2021 | 30/04/2019 | Paragraph 7(2)(l) in the Therapeutic Goods Order No. 69 – General requirements for labels for medicines 2017. | The labels for the products do not include the name and address of the current sponsor | The labels to which this consent applies are those previously approved for the former sponsor Genzyme Australia Pty Ltd. Further, arrangements are in place with the former sponsor. Genzyme Australia Pty Ltd, for prompt referral of any queries or complaints concerning the products to the Sanofi-Aventis Australia Ltd. | Import and supply | Prescription medicines | |
| FLUDARA ORAL fludarabine phosphate 10 mg tablet blister pack | Sanofi-Aventis Australia Pty Ltd | 81998 | CON-361 | The consent is effective from 30 April 2019 until 29 April 2021 | 30/04/2019 | Paragraph 7(2)(l) in the Therapeutic Goods Order No. 69 – General requirements for labels for medicines 2017. | The labels for the products do not include the name and address of the current sponsor | The labels to which this consent applies are those previously approved for the former sponsor Genzyme Australia Pty Ltd. Further, arrangements are in place with the former sponsor. Genzyme Australia Pty Ltd, for prompt referral of any queries or complaints concerning the products to the Sanofi-Aventis Australia Ltd. | Import and supply | Prescription medicines | |
| THYROGEN thyrotropin alfa-rch 0.9 mg powder for injection vial | Sanofi-Aventis Australia Pty Ltd | 79777 | CON-361 | The consent is effective from 30 April 2019 until 29 April 2021 | 30/04/2019 | Paragraph 7(2)(l) in the Therapeutic Goods Order No. 69 – General requirements for labels for medicines 2017. | The labels for the products do not include the name and address of the current sponsor | The labels to which this consent applies are those previously approved for the former sponsor Genzyme Australia Pty Ltd. Further, arrangements are in place with the former sponsor. Genzyme Australia Pty Ltd, for prompt referral of any queries or complaints concerning the products to the Sanofi-Aventis Australia Ltd. | Import and supply | Prescription medicines | |
| CEREZYME imiglucerase-rch 400U powder for injection vial | Sanofi-Aventis Australia Pty Ltd | 74277 | CON-361 | The consent is effective from 30 April 2019 until 29 April 2021 | 30/04/2019 | Paragraph 7(2)(l) in the Therapeutic Goods Order No. 69 – General requirements for labels for medicines 2017. | The labels for the products do not include the name and address of the current sponsor | The labels to which this consent applies are those previously approved for the former sponsor Genzyme Australia Pty Ltd. Further, arrangements are in place with the former sponsor. Genzyme Australia Pty Ltd, for prompt referral of any queries or complaints concerning the products to the Sanofi-Aventis Australia Ltd. | Import and supply | Prescription medicines | |
| MOZOBIL plerixafor 20 mg/ mL solution for injection 1.2 mL vial | Sanofi-Aventis Australia Pty Ltd | 158423 | CON-361 | The consent is effective from 30 April 2019 until 29 April 2021 | 30/04/2019 | Paragraph 7(2)(l) in the Therapeutic Goods Order No. 69 – General requirements for labels for medicines 2017. | The labels for the products do not include the name and address of the current sponsor | The labels to which this consent applies are those previously approved for the former sponsor Genzyme Australia Pty Ltd. Further, arrangements are in place with the former sponsor. Genzyme Australia Pty Ltd, for prompt referral of any queries or complaints concerning the products to the Sanofi-Aventis Australia Ltd. | Import and supply | Prescription medicines | |
| THYMOGLOBULINE rabbit anti-human thymocyte immunoglobulin - powder for solution for infusion vial | Sanofi-Aventis Australia Pty Ltd | 139787 | CON-361 | The consent is effective from 30 April 2019 until 29 April 2021 | 30/04/2019 | Paragraph 7(2)(l) in the Therapeutic Goods Order No. 69 – General requirements for labels for medicines 2017. | The labels for the products do not include the name and address of the current sponsor | The labels to which this consent applies are those previously approved for the former sponsor Genzyme Australia Pty Ltd. Further, arrangements are in place with the former sponsor. Genzyme Australia Pty Ltd, for prompt referral of any queries or complaints concerning the products to the Sanofi-Aventis Australia Ltd. | Import and supply | Prescription medicines | |
| MYOZYME alglucosidase alfa-rch 50 mg / 10 mL powder for concentrate for solution for infusion | Sanofi-Aventis Australia Pty Ltd | 136005 | CON-361 | The consent is effective from 30 April 2019 until 29 April 2021 | 30/04/2019 | Paragraph 7(2)(l) in the Therapeutic Goods Order No. 69 – General requirements for labels for medicines 2017. | The labels for the products do not include the name and address of the current sponsor | The labels to which this consent applies are those previously approved for the former sponsor Genzyme Australia Pty Ltd. Further, arrangements are in place with the former sponsor. Genzyme Australia Pty Ltd, for prompt referral of any queries or complaints concerning the products to the Sanofi-Aventis Australia Ltd. | Import and supply | Prescription medicines | |
| ELAPRASE idursulfase-rhu solution for IV infusion vial | Sanofi-Aventis Australia Pty Ltd | 129481 | CON-361 | The consent is effective from 30 April 2019 until 29 April 2021 | 30/04/2019 | Paragraph 7(2)(l) in the Therapeutic Goods Order No. 69 – General requirements for labels for medicines 2017. | The labels for the products do not include the name and address of the current sponsor | The labels to which this consent applies are those previously approved for the former sponsor Genzyme Australia Pty Ltd. Further, arrangements are in place with the former sponsor. Genzyme Australia Pty Ltd, for prompt referral of any queries or complaints concerning the products to the Sanofi-Aventis Australia Ltd. | Import and supply | Prescription medicines | |
| MABCAMPATH alemtuzumab 30 mg/mL concentrate solution for infusion vial | Sanofi-Aventis Australia Pty Ltd | 116622 | CON-361 | The consent is effective from 30 April 2019 until 29 April 2021 | 30/04/2019 | Paragraph 7(2)(l) in the Therapeutic Goods Order No. 69 – General requirements for labels for medicines 2017. | The labels for the products do not include the name and address of the current sponsor | The labels to which this consent applies are those previously approved for the former sponsor Genzyme Australia Pty Ltd. Further, arrangements are in place with the former sponsor. Genzyme Australia Pty Ltd, for prompt referral of any queries or complaints concerning the products to the Sanofi-Aventis Australia Ltd. | Import and supply | Prescription medicines | |
| RENAGEL sevelamer hydrochloride 800 mg tablet bottle | Sanofi-Aventis Australia Pty Ltd | 101553 | CON-361 | The consent is effective from 30 April 2019 until 29 April 2021 | 30/04/2019 | Paragraph 7(2)(l) in the Therapeutic Goods Order No. 69 – General requirements for labels for medicines 2017. | The labels for the products do not include the name and address of the current sponsor | The labels to which this consent applies are those previously approved for the former sponsor Genzyme Australia Pty Ltd. Further, arrangements are in place with the former sponsor. Genzyme Australia Pty Ltd, for prompt referral of any queries or complaints concerning the products to the Sanofi-Aventis Australia Ltd. | Import and supply | Prescription medicines | |
| RENAGEL sevelamer hydrochloride 400 mg tablet bottle | Sanofi-Aventis Australia Pty Ltd | 101550 | CON-361 | The consent is effective from 30 April 2019 until 29 April 2021 | 30/04/2019 | Paragraph 7(2)(l) in the Therapeutic Goods Order No. 69 – General requirements for labels for medicines 2017. | The labels for the products do not include the name and address of the current sponsor | The labels to which this consent applies are those previously approved for the former sponsor Genzyme Australia Pty Ltd. Further, arrangements are in place with the former sponsor. Genzyme Australia Pty Ltd, for prompt referral of any queries or complaints concerning the products to the Sanofi-Aventis Australia Ltd. | Import and supply | Prescription medicines | |
| ALDURAZYME laronidase (rch) 500U/5 mL injection vial | Sanofi-Aventis Australia Pty Ltd | 100847 | CON-361 | The consent is effective from 30 April 2019 until 29 April 2021 | 30/04/2019 | Paragraph 7(2)(l) in the Therapeutic Goods Order No. 69 – General requirements for labels for medicines 2017. | The labels for the products do not include the name and address of the current sponsor | The labels to which this consent applies are those previously approved for the former sponsor Genzyme Australia Pty Ltd. Further, arrangements are in place with the former sponsor. Genzyme Australia Pty Ltd, for prompt referral of any queries or complaints concerning the products to the Sanofi-Aventis Australia Ltd. | Import and supply | Prescription medicines | |
| KINERET anakinra 100 mg/0.67 mL solution for injection prefilled syringe | A. Menarini Australia Pty Ltd | 82872 | CON-362 | The consent is effective from 8 May 2019 until further notice | 8/05/2019 | Paragraphs 8(1)(h), 8(1)(i), subparagraphs 9(3)(a)(ii), 11(5)(iii) and 11(5)(vi) in the Therapeutics Goods Order 91 - Standard for labels of prescription and related medicines | The product labels do not include thestorage conditionscontact details of the Sponsorthe active name and quantity of each active ingredient together immediately below the name of the medicine | 1. Supply is restricted to the UK sourced Kineret Product in Australian-specific 28s carton as provided to the Therapeutic Goods Administration (TGA )in the application.2. The sponsor must inform the TGA in at least once every 12 months of the numbers of patients treated with the Product in the previous 12 month period. This information should be submitted to biological.medicines@tga.gov.au unless you have reached agreement with the TGA for an alternative.3. A DearHealthCareP |