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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| FLAMAZINE silver sulfadiazine 1.0% w/w cream tube | Smith & Nephew Pty Ltd | 159342 | CON-1115 | The consent is effective from 19 December 2023 until 30 June 2024. | 19/12/2023 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The physical address of the sponsor on the product label will be incorrect following the permitted 12 month change over period for changes in the sponsor address. | The sponsor continues the mail redirection for the duration of the consent. | import and supply | Prescription medicines | |
| FLAMAZINE silver sulfadiazine 1.0% w/w cream jar | Smith & Nephew Pty Ltd | 159338 | CON-1115 | The consent is effective from 19 December 2023 until 30 June 2024. | 19/12/2023 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The physical address of the sponsor on the product label will be incorrect following the permitted 12 month change over period for changes in the sponsor address. | The sponsor continues the mail redirection for the duration of the consent. | import and supply | Prescription medicines | |
| ANDROFEME 1 testosterone 1% w/v (10 mg/mL) cream tube | Lawley Pharmaceuticals Pty Ltd | 324274 | CON-1174 | The consent is effective from 24 October 2023 until 31 July 2024. | 24/10/2023 | test method for trolamine of British Pharmacopoeia | The products do not conform to the requirements of The British Pharmacopoeia test method for trolamine in that the products do not include the test for Impurity C for the excipient trolamine. | supply and export | Prescription medicines | ||
| ANDROFORTE 5 testosterone 5% w/v (50 mg/mL) cream tube | Lawley Pharmaceuticals Pty Ltd | 123764 | CON-1174 | The consent is effective from 24 October 2023 until 31 July 2024. | 24/10/2023 | test method for trolamine of British Pharmacopoeia | The products do not conform to the requirements of The British Pharmacopoeia test method for trolamine in that the products do not include the test for Impurity C for the excipient trolamine. | supply and export | Prescription medicines | ||
| OLANZAPINE SANDOZ olanzapine 7.5 mg film coated tablet, blister pack | Sandoz Pty Ltd | 148474 | CON-1173 | The consent is effective from 23 October 2023 until 31 December 2024. | 23/10/2023 | of United States Pharmacopoeia | The method equivalency of in-house Dissolution, Assay and Related Substances methods with the official standard when tested by the methods specified by the standard have not been established. | import and supply | Prescription medicines | ||
| OLANZAPINE SANDOZ olanzapine 5 mg film coated tablet, blister pack | Sandoz Pty Ltd | 148469 | CON-1173 | The consent is effective from 23 October 2023 until 31 December 2024. | 23/10/2023 | of United States Pharmacopoeia | The method equivalency of in-house Dissolution, Assay and Related Substances methods with the official standard when tested by the methods specified by the standard have not been established. | import and supply | Prescription medicines | ||
| OLANZAPINE SANDOZ olanzapine 10 mg film coated tablet, blister pack | Sandoz Pty Ltd | 148451 | CON-1173 | The consent is effective from 23 October 2023 until 31 December 2024. | 23/10/2023 | of United States Pharmacopoeia | The method equivalency of in-house Dissolution, Assay and Related Substances methods with the official standard when tested by the methods specified by the standard have not been established. | import and supply | Prescription medicines | ||
| OLANZAPINE SANDOZ olanzapine 2.5 mg film coated tablet, blister pack | Sandoz Pty Ltd | 148450 | CON-1173 | The consent is effective from 23 October 2023 until 31 December 2024. | 23/10/2023 | of United States Pharmacopoeia | The method equivalency of in-house Dissolution, Assay and Related Substances methods with the official standard when tested by the methods specified by the standard have not been established. | import and supply | Prescription medicines | ||
| OLANZAPINE SANDOZ olanzapine 7.5 mg film coated tablet, blister pack | Sandoz Pty Ltd | 148474 | CON-1172 | The consent is effective from 23 October 2023 until 31 December 2024. | 23/10/2023 | of British Pharmacopoeia | The method equivalency of in-house Dissolution, Assay and Related Substances methods with the official standard when tested by the methods specified by the standard have not been established. | import and supply | Prescription medicines | ||
| OLANZAPINE SANDOZ olanzapine 5 mg film coated tablet, blister pack | Sandoz Pty Ltd | 148469 | CON-1172 | The consent is effective from 23 October 2023 until 31 December 2024. | 23/10/2023 | of British Pharmacopoeia | The method equivalency of in-house Dissolution, Assay and Related Substances methods with the official standard when tested by the methods specified by the standard have not been established. | import and supply | Prescription medicines | ||
| OLANZAPINE SANDOZ olanzapine 10 mg film coated tablet, blister pack | Sandoz Pty Ltd | 148451 | CON-1172 | The consent is effective from 23 October 2023 until 31 December 2024. | 23/10/2023 | of British Pharmacopoeia | The method equivalency of in-house Dissolution, Assay and Related Substances methods with the official standard when tested by the methods specified by the standard have not been established. | import and supply | Prescription medicines | ||
| OLANZAPINE SANDOZ olanzapine 2.5 mg film coated tablet, blister pack | Sandoz Pty Ltd | 148450 | CON-1172 | The consent is effective from 23 October 2023 until 31 December 2024. | 23/10/2023 | of British Pharmacopoeia | The method equivalency of in-house Dissolution, Assay and Related Substances methods with the official standard when tested by the methods specified by the standard have not been established. | import and supply | Prescription medicines | ||
| PRIORIX-TETRA vaccine 0.5mL powder for injection vial with diluent syringe | GlaxoSmithKline Australia Pty Ltd | 107286 | CON-1170 | The consent is effective from 17 October 2023 until 17 October 2025. | 17/10/2023 | paragraphs 8(1)(b) and 9(1)(b) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The name of an active ingredient on the carton label does not align with the Australian Approved Name (AAN). | • Non-compliance is limited to TGO 91 requirements only, • The non-compliant label will be revised to become fully compliant with TGO 91, • The ingredients on medicine labels must be identified by AANs. Synonyms must not be used in place of the approved names, and • This exemption applies only to the product released in the Australian market before 17 October 2025. | import and supply | Prescription medicines | |
| ALLMERCAP mercaptopurine monohydrate 20 mg/mL oral liquid suspension bottle | Link Medical Products Pty Ltd T A Link Pharmaceuticals | 213881 | CON-1169 | The consent is effective from 6 October 2023 until 30 June 2024. | 6/10/2023 | Paragraphs 8(1)(a), 9(1)(a), Paragraphs 8(1)(b) and 9(1)(b), • Subparagraph 8(1)(j)(iv)(A), Paragraph 9(3)(a), Paragraph 8(1)(i), Paragraph 10(4)(j) and Subsection 11(5) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s): will be supplied in the UK approved packaging which has the following differences: the name Xaluprine in place of Allmercap; the active ingredient name is referred to as mercaptopurine instead of mercaptopurine monohydrate; the name and quantity of the active ingredient are not in a cohesive unit with the name of the medicine; the storage statement is not in the permitted format; the Schedule 1 substances aspartame and potassium sorbate are not expressed as required; the sponsor’s name and address are not included on the label and the name of the sponsor is not included on the bottle label. | 1. A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 22 September 2023 will be supplied with each affected batch describing the differences in the labels. 2. Sponsor details will be attached to the labels in such a way as to not impact any other relevant information on the labels. | import and supply | Prescription medicines | |
| OMVOH mirikizumab 300 mg/15 mL (20 mg/mL) concentrated injection vial for IV infusion | Eli Lilly Australia Pty Ltd | 391349 | CON-1171 | The consent is effective from 26 September 2023 until 30 September 2026. | 26/09/2023 | Paragraphs 8(1)(f) & 10(4)(h) & Paragraphs 8(1)(g) & 10(4)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | #NAME? | import and supply | Prescription medicines | ||
| OMVOH mirikizumab 100 mg/mL solution for injection pre-filled syringe | Eli Lilly Australia Pty Ltd | 391348 | CON-1171 | The consent is effective from 26 September 2023 until 30 September 2026. | 26/09/2023 | Paragraphs 8(1)(f) & 10(4)(h) & Paragraphs 8(1)(g) & 10(4)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | #NAME? | import and supply | Prescription medicines | ||
| HYDROGEN PEROXIDE SOLUTION 3% BP | AFT Pharmaceuticals Pty Ltd | 62624 | 76303F, 77378J, 77378K, 77730D, 77730E, 77730F, 77730G, 77730J, 77730K, 77904A, 77904B, 77904C, 77904D, 77904E, 77904F, 77904G, 77904H, 77904J, 77904K | CON-1166 | The consent is effective from 22 September 2023 until 26 April 2025. | 22/09/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of the current sponsor, instead the labels bear the name and contact details of the previous sponsor Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare. | There are arrangements in place with Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare [the former sponsor] for the prompt referral of any queries or complaints concerning the products to AFT Pharmaceuticals Pty Ltd [the current sponsor]. | supply | Listed complementary medicines |
| GLYCERINE | AFT Pharmaceuticals Pty Ltd | 29612 | 76028C, 76954B, 76954C, 77902A , 77902B | CON-1166 | The consent is effective from 22 September 2023 until 26 April 2025. | 22/09/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of the current sponsor, instead the labels bear the name and contact details of the previous sponsor Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare. | There are arrangements in place with Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare [the former sponsor] for the prompt referral of any queries or complaints concerning the products to AFT Pharmaceuticals Pty Ltd [the current sponsor]. | supply | Listed complementary medicines |
| Proctosedyl Witch Hazel | AFT Pharmaceuticals Pty Ltd | 317893 | 75078, 75309, 75521, 76651 | CON-1166 | The consent is effective from 22 September 2023 until 26 April 2025. | 22/09/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of the current sponsor, instead the labels bear the name and contact details of the previous sponsor Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare. | There are arrangements in place with Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare [the former sponsor] for the prompt referral of any queries or complaints concerning the products to AFT Pharmaceuticals Pty Ltd [the current sponsor]. | supply | Listed complementary medicines |
| RUZURGI amifampridine 10 mg tablet bottle | Lacuna Pharma Pty Ltd | 352630 | CON-1165 | The consent is effective from 19 September 2023 until 30 September 2025. | 19/09/2023 | subsections 9(1), 9(2) and 9(3) of Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95) | The sponsor of the medicine does not hold evidence of relevant compliance | import and supply | Prescription medicines | ||
| BIOSTATE human coagulation factor VIII 1000IU/ von Willebrand factor 2400IU powder for injection vial with diluent vial | CSL Behring (Australia) Pty Ltd | 150657 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| BIOSTATE human coagulation factor VIII 500IU/ von Willebrand factor 1200IU powder for injection vial with diluent vial | CSL Behring (Australia) Pty Ltd | 150648 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| BIOSTATE human coagulation factor VIII 500IU / von Willebrand Factor 1200IU powder for injection vial with diluent vial | CSL Behring (Australia) Pty Ltd | 79993 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| BIOSTATE human coagulation factor VIII 250IU / von Willebrand Factor 600IU powder for injection vial with diluent vial | CSL Behring (Australia) Pty Ltd | 73032 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| CSL NORMAL IMMUNOGLOBULIN VF (human) 800 mg/5 mL injection vial | CSL Behring (Australia) Pty Ltd | 61216 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| CSL NORMAL IMMUNOGLOBULIN VF (human) 320 mg/2 mL injection vial | CSL Behring (Australia) Pty Ltd | 61215 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| CSL HEPATITIS B IMMUNOGLOBULIN VF (human) 400IU injection vial | CSL Behring (Australia) Pty Ltd | 61214 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| CSL HEPATITIS B IMMUNOGLOBULIN VF (human) 100IU injection vial | CSL Behring (Australia) Pty Ltd | 61213 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| CSL ZOSTER IMMUNOGLOBULIN VF (human) 200IU injection vial | CSL Behring (Australia) Pty Ltd | 61219 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| CSL Rh(D) IMMUNOGLOBULIN VF (human) 250 IU injection vial | CSL Behring (Australia) Pty Ltd | 76643 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| CSL Rh(D) IMMUNOGLOBULIN VF (human) 625IU injection vial | CSL Behring (Australia) Pty Ltd | 61217 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| CSL TETANUS IMMUNOGLOBULIN-VF (human) for intravenous use 4000 IU injection vial | CSL Behring (Australia) Pty Ltd | 31829 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| CSL TETANUS IMMUNOGLOBULIN-VF (human) 250IU injection vial | CSL Behring (Australia) Pty Ltd | 61218 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| CSL CMV IMMUNOGLOBULIN-VF (human) 1.5 million units/vial injection vial | CSL Behring (Australia) Pty Ltd | 31810 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| HIZENTRA AU Human Normal Immunoglobulin 20% Solution for Subcutaneous Injection 50 mL vial | CSL Behring (Australia) Pty Ltd | 328609 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| HIZENTRA AU Human Normal Immunoglobulin 20% Solution for Subcutaneous Injection 20 mL vial | CSL Behring (Australia) Pty Ltd | 328608 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| HIZENTRA AU Human Normal Immunoglobulin 20% Solution for Subcutaneous Injection 10 mL vial | CSL Behring (Australia) Pty Ltd | 328607 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| HIZENTRA AU Human Normal Immunoglobulin 20% Solution for Subcutaneous Injection 5 mL vial | CSL Behring (Australia) Pty Ltd | 328606 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| PRIVIGEN AU normal immunoglobulin (human) 40g (100g/L, 10%) solution for intravenous infusion | CSL Behring (Australia) Pty Ltd | 328605 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| PRIVIGEN AU normal immunoglobulin (human) 20g (100g/L, 10%) solution for intravenous infusion | CSL Behring (Australia) Pty Ltd | 328603 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| PRIVIGEN AU normal immunoglobulin (human) 10g (100g/L, 10%) solution for intravenous infusion | CSL Behring (Australia) Pty Ltd | 328602 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| PRIVIGEN AU normal immunoglobulin (human) 5g (100g/L, 10%) solution for intravenous infusion | CSL Behring (Australia) Pty Ltd | 328601 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| ALBUREX 5 AU Human Albumin 50 g/L (5% w/v) 500 mL solution for intravenous infusion vial | CSL Behring (Australia) Pty Ltd | 327951 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| ALBUREX 5 AU Human Albumin 50 g/L (5% w/v) 250 mL solution for intravenous infusion vial | CSL Behring (Australia) Pty Ltd | 327950 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| ALBUREX 20 AU Human Albumin 200 g/L (20% w/v) 100 mL solution for intravenous infusion vial | CSL Behring (Australia) Pty Ltd | 327953 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| ALBUREX 20 AU Human Albumin 200 g/L (20% w/v) 50 mL solution for intravenous infusion vial | CSL Behring (Australia) Pty Ltd | 327952 | CON-1164 | The consent is effective from 15 September 2023 until 1 October 2031. (the sunset date of TGO 108). | 15/09/2023 | Part 2 Section 10(9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Prescription medicines | |
| SUMAGRAINE MIGRAINE RELIEF sumatriptan 50 mg (as succinate) tablet blister pack | Lupin Australia Pty Limited | 160180 | G324921 | CON-1163 | The consent is effective from 14 September 2023 until batch G324921 is depleted. | 14/09/2023 | paragraph 8(2)(e) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product does not comply because the label statement “Contains sugars as lactose” that is included at the end of the critical health information (CHI) panel goes beyond the type of information permitted to be included under the Other Information section of the CHI panel by paragraph 8(2)(e) of the TGO 92. | supply | Over-the-counter medicines | |
| NEBILET nebivolol (as hydrochloride) 1.25 mg/5 mg composite starter titration tablet blister pack | A Menarini Australia Pty Ltd | 148895 | CON-1162 | The consent is effective from 14 September 2023 until 31 December 2024. | 14/09/2023 | Analytical procedures for Assay and Related Substances of European Pharmacopoeia | The product(s) do not meet the Ph. Eur. monograph for Nebivolol hydrochloride analytical procedures used to determine Assay and Related Substances. | import, supply, and export | Prescription medicines | ||
| NEBILET nebivolol (as hydrochloride) 10 mg tablet blister pack | A Menarini Australia Pty Ltd | 148875 | CON-1162 | The consent is effective from 14 September 2023 until 31 December 2024. | 14/09/2023 | Analytical procedures for Assay and Related Substances of European Pharmacopoeia | The product(s) do not meet the Ph. Eur. monograph for Nebivolol hydrochloride analytical procedures used to determine Assay and Related Substances. | import, supply, and export | Prescription medicines | ||
| NEBILET nebivolol (as hydrochloride) 5 mg tablet blister pack | A Menarini Australia Pty Ltd | 148874 | CON-1162 | The consent is effective from 14 September 2023 until 31 December 2024. | 14/09/2023 | Analytical procedures for Assay and Related Substances of European Pharmacopoeia | The product(s) do not meet the Ph. Eur. monograph for Nebivolol hydrochloride analytical procedures used to determine Assay and Related Substances. | import, supply, and export | Prescription medicines | ||
| NEBILET nebivolol (as hydrochloride) 1.25 mg tablet blister pack | A Menarini Australia Pty Ltd | 148873 | CON-1162 | The consent is effective from 14 September 2023 until 31 December 2024. | 14/09/2023 | Analytical procedures for Assay and Related Substances of European Pharmacopoeia | The product(s) do not meet the Ph. Eur. monograph for Nebivolol hydrochloride analytical procedures used to determine Assay and Related Substances. | import, supply, and export | Prescription medicines | ||
| Pfizer (Australia) SODIUM CHLORIDE 0.9% (45 mg/5 mL) injection BP ampoule | Bridgewest Perth Pharma Pty Ltd | 49272 | CON-1161 | All relevant batches released from the 11 September 2023 until the 30 September 2025. | 11/09/2023 | subparagraph 10(15)(b)(vi) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product does not comply because AUST R 49272 does not contain the word ‘only’ on the ampoule label | supply | Prescription medicines | ||
| Bridgewest SODIUM CHLORIDE 0.9% (270 mg/30 mL) irrigation solution ampoule | Bridgewest Perth Pharma Pty Ltd | 11290 | CON-1160 | All relevant batches released from the 11 September 2023 until the 30 September 2025. | 11/09/2023 | Paragraph 8(1)(i), Subsection 9(4), Subsection 9(5), subsections 9(6), 9(7), 9(8) and 9(9), of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) do not comply because: • AUST R 11290 does not contain the contact details of the sponsor, does not have all text oriented in the same direction and the name of the active ingredient is in font less than 3.0mm. | supply | Prescription medicines | ||
| Midazolam-Baxter midazolam (as hydrochloride) 15 mg/3 mL solution for injection ampoule | Baxter Healthcare Pty Ltd | 216026 | CON-1159 | The consent is effective from the 11 September 2023 until the expiry date of batch B5G0101A. | 11/09/2023 | Paragraph 10(4)(b) of Therapeutic Goods (Medicines - Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021 | The product(s) has a data matrix code that has information printed in a numerical format rather than an alphabetical pattern. | import and supply | Prescription medicines | ||
| RISPERIDONE LAPL risperidone 1 mg/mL oral liquid solution bottle | Generic Health Pty Ltd | 389692 | CON-1168 | The consent is effective from 5 September 2023 until 5 March 2025. | 5/09/2023 | pH limit range of British Pharmacopoeia | •The drug product expiry specifications state a pH limit range of pH 1.65 – 1.95. •The Risperidone Oral Solution (British Pharmacopoeia 2024) monograph specifies a pH limit of 2.0 – 4.0. •The Risperidone Oral Solution (United States Pharmacopoeia 2023) monograph also specifies a pH limit of 2.0 – 4.0. | The pH of the risperidone oral solution is in the range 1.65 – 1.95 | import and supply | Prescription medicines | |
| RISPERIDONE GENERICHEALTH risperidone 1 mg/mL oral liquid solution bottle | Generic Health Pty Ltd | 389691 | CON-1168 | The consent is effective from 5 September 2023 until 5 March 2025. | 5/09/2023 | pH limit range of British Pharmacopoeia | •The drug product expiry specifications state a pH limit range of pH 1.65 – 1.95. •The Risperidone Oral Solution (British Pharmacopoeia 2024) monograph specifies a pH limit of 2.0 – 4.0. •The Risperidone Oral Solution (United States Pharmacopoeia 2023) monograph also specifies a pH limit of 2.0 – 4.0. | The pH of the risperidone oral solution is in the range 1.65 – 1.95 | import and supply | Prescription medicines | |
| RISPERIDONE LUPIN risperidone 1 mg/mL oral liquid solution bottle | Generic Health Pty Ltd | 389690 | CON-1168 | The consent is effective from 5 September 2023 until 5 March 2025. | 5/09/2023 | pH limit range of British Pharmacopoeia | •The drug product expiry specifications state a pH limit range of pH 1.65 – 1.95. •The Risperidone Oral Solution (British Pharmacopoeia 2024) monograph specifies a pH limit of 2.0 – 4.0. •The Risperidone Oral Solution (United States Pharmacopoeia 2023) monograph also specifies a pH limit of 2.0 – 4.0. | The pH of the risperidone oral solution is in the range 1.65 – 1.95 | import and supply | Prescription medicines | |
| RISPERIDONE LAPL risperidone 1 mg/mL oral liquid solution bottle | Generic Health Pty Ltd | 389692 | CON-1167 | The consent is effective from 5 September 2023 until 5 March 2025. | 5/09/2023 | pH limit range of United States Pharmacopoeia | •The drug product expiry specifications state a pH limit range of pH 1.65 – 1.95. •The Risperidone Oral Solution (British Pharmacopoeia 2024) monograph specifies a pH limit of 2.0 – 4.0. •The Risperidone Oral Solution (United States Pharmacopoeia 2023) monograph also specifies a pH limit of 2.0 – 4.0. | The pH of the risperidone oral solution is in the range 1.65 – 1.95 | import and supply | Prescription medicines | |
| RISPERIDONE GENERICHEALTH risperidone 1 mg/mL oral liquid solution bottle | Generic Health Pty Ltd | 389691 | CON-1167 | The consent is effective from 5 September 2023 until 5 March 2025. | 5/09/2023 | pH limit range of United States Pharmacopoeia | •The drug product expiry specifications state a pH limit range of pH 1.65 – 1.95. •The Risperidone Oral Solution (British Pharmacopoeia 2024) monograph specifies a pH limit of 2.0 – 4.0. •The Risperidone Oral Solution (United States Pharmacopoeia 2023) monograph also specifies a pH limit of 2.0 – 4.0. | The pH of the risperidone oral solution is in the range 1.65 – 1.95 | import and supply | Prescription medicines | |
| RISPERIDONE LUPIN risperidone 1 mg/mL oral liquid solution bottle | Generic Health Pty Ltd | 389690 | CON-1167 | The consent is effective from 5 September 2023 until 5 March 2025. | 5/09/2023 | pH limit range of United States Pharmacopoeia | •The drug product expiry specifications state a pH limit range of pH 1.65 – 1.95. •The Risperidone Oral Solution (British Pharmacopoeia 2024) monograph specifies a pH limit of 2.0 – 4.0. •The Risperidone Oral Solution (United States Pharmacopoeia 2023) monograph also specifies a pH limit of 2.0 – 4.0. | The pH of the risperidone oral solution is in the range 1.65 – 1.95 | import and supply | Prescription medicines | |
| PHENOXYMETHYLPENICILLIN-AFT phenoxymethylpenicillin (as potassium salt) 250 mg/5 ml powder for oral liquid bottle | AFT Pharmaceuticals Pty Ltd | 159754 | CON-1158 | The consent is effective from 4 September 2023 until 30 September 2024. | 4/09/2023 | The British Pharmacopeia monograph for Phenoxymethylpenicillin Oral Solution with respect to the specifications for the related substances test. of British Pharmacopoeia | The product(s) are unable to meet the requirements of the British Pharmacopeia with respect to related substances over their shelf life. | import and supply | Prescription medicines | ||
| PHENOXYMETHYLPENICILLIN-AFT phenoxymethylpenicillin (as potassium salt) 125 mg/5 ml powder for oral liquid bottle | AFT Pharmaceuticals Pty Ltd | 159753 | CON-1158 | The consent is effective from 4 September 2023 until 30 September 2024. | 4/09/2023 | The British Pharmacopeia monograph for Phenoxymethylpenicillin Oral Solution with respect to the specifications for the related substances test. of British Pharmacopoeia | The product(s) are unable to meet the requirements of the British Pharmacopeia with respect to related substances over their shelf life. | import and supply | Prescription medicines | ||
| LUXTURNA voretigene neparvovec 5 x 10(12) (vg) per mL concentrate solution for injection vial with diluent ampoule | Novartis Pharmaceuticals Australia Pty Limited | 318929 | CON-1156 | The consent is effective from 1 September 2023 until 1 June 2024. | 1/09/2023 | Folding Box: • Section 9(3)(a) • Section 10(3)(a)(i) • Section 10(2)(f): • Section 8(1)(i): • Section 8(1)(o): Pouch: • Section 9(3)(a): • Section 8(1)(i) & 8(3)(f): of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product label does not comply with TGO 91 in that: Folding Box: • The Active ingredient is not immediately under the tradename. • The AAN and excipient amount missing (injectable). • The Statement "Use in one patient on one occasion. Contains no antimicrobial preservative" is missing. • The AU sponsor address is missing. • There are not 3 sides with the tradename. Pouch: • The Active ingredient is not immediately under the tradename. • The AU sponsor address is missing. | import and supply | Prescription medicines | ||
| SANOFI CALAMINE LOTION bottle | AFT Pharmaceutical Pty Ltd | 106995 | 77901A, 77901C and 78327A | CON-1153 | The consent is effective from 23 August 2023 until 23 August 2025. | 23/08/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and contact details of the previous sponsor Sanofi-Aventis Healthcare Pty Ltd instead of the current sponsor AFT Pharmaceuticals Pty Ltd. | supply | Over-the-counter medicines | |
| Paxyl Spray aerosol | AFT Pharmaceutical Pty Ltd | 29636 | 1120687 | CON-1153 | The consent is effective from 23 August 2023 until 23 August 2025. | 23/08/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and contact details of the previous sponsor Sanofi-Aventis Healthcare Pty Ltd instead of the current sponsor AFT Pharmaceuticals Pty Ltd. | supply | Over-the-counter medicines | |
| PROCTOSEDYL OINTMENT tube | AFT Pharmaceutical Pty Ltd | 21847 | 8137456, 8139819, 8142095, 8142920, 8142922, 8142923, 8142925, 8147323 and 8147324 | CON-1153 | The consent is effective from 23 August 2023 until 23 August 2025. | 23/08/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and contact details of the previous sponsor Sanofi-Aventis Healthcare Pty Ltd instead of the current sponsor AFT Pharmaceuticals Pty Ltd. | supply | Over-the-counter medicines | |
| PROCTOSEDYL SUPPOSITORIES Strip Pack | AFT Pharmaceutical Pty Ltd | 22614 | 242, 245, 248 and 249 | CON-1153 | The consent is effective from 23 August 2023 until 23 August 2025. | 23/08/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and contact details of the previous sponsor Sanofi-Aventis Healthcare Pty Ltd instead of the current sponsor AFT Pharmaceuticals Pty Ltd. | supply | Over-the-counter medicines | |
| DEXAMETHASONE VIATRIS dexamethasone phosphate (as dexamethasone sodium phosphate) 4 mg/1 mL solution for injection vial | Alphapharm Pty Ltd | 163200 | All batches of the product(s) with pH greater than or equal to 9.0. | CON-1152 | The consent is effective from 11 August 2023 until 1 August 2024. | 11/08/2023 | The product does not meet the pH requirements in the monograph of British Pharmacopoeia | The product does not conform with the requirements of the BP monograph for Dexamethasone Sodium Phosphate Injection. | A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 1 August 2023 will be supplied with each affected batch. The Therapeutic Goods Administration must be informed immediately by writing to the decision delegate if any batch of the product(s) is analysed and the results obtained for pH are greater than or equal to pH 9.0. | import and supply | Prescription medicines |
| TRUXIMA rituximab (rch) 500 mg/ 50 mL concentrate solution for intravenous infusion | Celltrion Healthcare Australia Pty Ltd | 285815 | 0C8C211 and 0C8C382 | CON-1150 | The consent is effective from 9 August 2023 for Batch Numbers 0C8C211 and 0C8C382 until 12 August 2025. | 9/08/2023 | subsection 7(1), paragraph Section 9(1)(d), paragraph 8(1)(i), paragraph 10(3)(a), paragraph 10(3)(b), paragraph 10(3)(c). of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product’s vial label does not comply as follows: •subsection 7(1) - The container, intermediate packaging (if any) and primary pack in which a medicine is packed must each bear a label or labels that comply with the requirements of this Order that are applicable in relation to that medicine. The vial label is not compliant with this subsection as detailed below. •paragraph 9(1)(d) - the name of the dosage form is not included on the on the label, only '..for Injection' and I.V. infusion included. •paragraph 8(1)(i) - the vial label does not include distributor details of the medicine. •paragraph 10(3)(a) - the vial label does not include the excipient details of the medicine. • paragraph 10(3)(b) - the vial label does not include the statements 'Úse in one patient on one occasion. Contains no antimicrobial preservative' only includes text 'Discard unused portion.' • paragraph 10(3)(c) the vial label only includes wording 'Dilute before use' rather than the statement 'Do not to administer the solution undiluted.' | 1. A ‘DHCP’ letter identical to that provided to the Therapeutic Goods Administration on 9 August 2023 will be supplied with each affected batch 2. The labels to which this consent applies are for batches of the product as stated. | import and supply | Prescription medicines |
| HERZUMA trastuzumab (rch) 150 mg powder for injection for intravenous infusion vial | Celltrion Healthcare Australia Pty Ltd | 289146 | 0A5C02 | CON-1149 | The consent is effective from 9 August 2023 for Batch Number 0A5C02 until 29 February 2024. | 9/08/2023 | subsection 7(1), paragraph7(2)(b), paragraph 10(3)(b), paragraph 10(4)(f), paragraph 10(4)(j), paragraph 11(5)(iii). of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product’s vial label does not comply as follows due to international labelling: • subsection 7(1) - The container, intermediate packaging (if any) and primary pack in which a medicine is packed must each bear a label or labels that comply with the requirements of this Order that are applicable in relation to that medicine. The vial label is not compliant with this subsection as detailed below. • subsection 7(2)(b) - Information on the vial label is presented in both French and English. • subsection 10(3)(b) - The vial does not state "Contains no antimicrobial preservative. Use in one patient on one occasion only." • subsection 10(4)(f) – The vial label states "Trastuzumab for Injection". The AU vial label states "Powder for injection" subsection 10(4)(j) - The vial label does not include the Australian Sponsor details. • subsection 11(5)(iii) - The label states "Store at 2°C to 8°C", but does not contain "(Refrigerate. Do not freeze)". | 1. A ‘HCP’ letter identical to that provided to the Therapeutic Goods Administration on 3 August 2023 will be supplied with each affected batch. 2. The labels to which this consent applies are for the batch of the product stated in the letter. | import and supply | Prescription medicines |
| MOUNJARO tirzepatide 2.5 mg/0.5 mL solution for injection vial | Eli Lilly Australia Pty Ltd | 407055 | CON-1146 | The consent is effective from 7 August 2023 until 1 October 2026. | 7/08/2023 | Paragraph 8(3)(d), Paragraph 8(3)(e), Paragraph 10(5)(e), Paragraph 10(5)(f). of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not conform as the labels for both the carton and vial have the batch number and expiry date prefix above the information rather than preceding it. | import and supply | Prescription medicines | ||
| MOUNJARO tirzepatide 15 mg/0.5 mL solution for injection vial | Eli Lilly Australia Pty Ltd | 407054 | CON-1146 | The consent is effective from 7 August 2023 until 1 October 2026. | 7/08/2023 | Paragraph 8(3)(d), Paragraph 8(3)(e), Paragraph 10(5)(e), Paragraph 10(5)(f). of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not conform as the labels for both the carton and vial have the batch number and expiry date prefix above the information rather than preceding it. | import and supply | Prescription medicines | ||
| MOUNJARO tirzepatide 10 mg/0.5 mL solution for injection vial | Eli Lilly Australia Pty Ltd | 407053 | CON-1146 | The consent is effective from 7 August 2023 until 1 October 2026. | 7/08/2023 | Paragraph 8(3)(d), Paragraph 8(3)(e), Paragraph 10(5)(e), Paragraph 10(5)(f). of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not conform as the labels for both the carton and vial have the batch number and expiry date prefix above the information rather than preceding it. | import and supply | Prescription medicines | ||
| MOUNJARO tirzepatide 12.5 mg/0.5 mL solution for injection vial | Eli Lilly Australia Pty Ltd | 407052 | CON-1146 | The consent is effective from 7 August 2023 until 1 October 2026. | 7/08/2023 | Paragraph 8(3)(d), Paragraph 8(3)(e), Paragraph 10(5)(e), Paragraph 10(5)(f). of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not conform as the labels for both the carton and vial have the batch number and expiry date prefix above the information rather than preceding it. | import and supply | Prescription medicines | ||
| MOUNJARO tirzepatide 7.5 mg/0.5 mL solution for injection vial | Eli Lilly Australia Pty Ltd | 407051 | CON-1146 | The consent is effective from 7 August 2023 until 1 October 2026. | 7/08/2023 | Paragraph 8(3)(d), Paragraph 8(3)(e), Paragraph 10(5)(e), Paragraph 10(5)(f). of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not conform as the labels for both the carton and vial have the batch number and expiry date prefix above the information rather than preceding it. | import and supply | Prescription medicines | ||
| MOUNJARO tirzepatide 5 mg/0.5 mL solution for injection vial | Eli Lilly Australia Pty Ltd | 407050 | CON-1146 | The consent is effective from 7 August 2023 until 1 October 2026. | 7/08/2023 | Paragraph 8(3)(d), Paragraph 8(3)(e), Paragraph 10(5)(e), Paragraph 10(5)(f). of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not conform as the labels for both the carton and vial have the batch number and expiry date prefix above the information rather than preceding it. | import and supply | Prescription medicines | ||
| SAYANA PRESS medroxyprogesterone acetate 104 mg/0.65 mL suspension for injection ampoule with attached needle | Pfizer Australia Pty Ltd | 401897 | CON-1151 | The consent is effective from 4 August 2023 until 4 August 2025. | 4/08/2023 | paragraphs 8(3)(d) and 8(3)(e) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The lot number and expiry details are not preceded by their respective prefixes on the intermediate packaging (pouch label). | import and supply | Prescription medicines | ||
| Plasma for fractionation | Australian Red Cross Lifeblood | CON-1155 | The consent is effective from the 1 August 2023 until the following conditions no longer remain true. | 1/08/2023 | The stated reason for the change in Guidelines for the Selection of Blood Donors (GSBD) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | Where single-use equipment is used, and it is less than 4 months since the procedure, Lifeblood accepts the donor for plasma for fractionation. | 1. The consent to supply those goods that do not conform to standards is restricted to donors who donate plasma for fractionation and does not include fresh blood products intended for clinical use. 2. The consent to supply is subject to the continued acceptance of CSL Behring who are responsible for plasma fractionation processes. | supply | Blood, tissues, and biologicals | ||
| Plasma for fractionation | Australian Red Cross Lifeblood | CON-1154 | The consent is effective from 1 August 2023 until the following conditions no longer remain true. | 1/08/2023 | The stated reason for the change in Guidelines for the Selection of Blood Donors (GSBD) of Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019 | Where single-use equipment is used, and it is less than 4 months since the procedure, Lifeblood accepts the donor for plasma for fractionation. | 1. The consent to supply those goods that do not conform to standards is restricted to donors who donate plasma for fractionation and does not include fresh blood products intended for clinical use. 2. The consent to supply is subject to the continued acceptance of CSL Behring who are responsible for plasma fractionation processes. | supply | Blood, tissues, and biologicals | ||
| NICABATE MINI LOZENGES nicotine 4 mg (as polacrilex) mint flavour lozenge tube (new formulation) | Haleon Australia Pty Ltd | 392046 | CON-1143 | The consent is effective from 31 July 2023 until 31 July 2025. | 31/07/2023 | Paragraphs 10(7)(c), 9(7)(ii), 10(7)(h), 10(7)(i) and 10(7)(j). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | Specifically, the container labels do not conform with requirements because: •the name of the medicine is displayed in a text height of less than 2 mm, •the active ingredient name and quantity are displayed in a text height of less than 2 mm, •the quantity of the medicine in the container is displayed in a text size of less than 1.5 mm, •the batch and expiry details do not include prefixes. | import, supply, and export | Over-the-counter medicines | ||
| NICABATE MINI LOZENGES nicotine 2 mg (as polacrilex) mint flavour lozenge tube | Haleon Australia Pty Ltd | 392045 | CON-1143 | The consent is effective from 31 July 2023 until 31 July 2025. | 31/07/2023 | Paragraphs 10(7)(c), 9(7)(ii), 10(7)(h), 10(7)(i) and 10(7)(j). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | Specifically, the container labels do not conform with requirements because: •the name of the medicine is displayed in a text height of less than 2 mm, •the active ingredient name and quantity are displayed in a text height of less than 2 mm, •the quantity of the medicine in the container is displayed in a text size of less than 1.5 mm, •the batch and expiry details do not include prefixes. | import, supply, and export | Over-the-counter medicines | ||
| PHARMACY ACTION COLD & FLU RELIEF DAY & NIGHT PE tablet blister pack | Noumed Pharmaceuticals Pty Ltd | 296311 | 1017132, 1017133, 1017168 and 1017363 | CON-1148 | The consent is effective from 27 July 2023 until all batches are exhausted. | 27/07/2023 | paragraph 10(9)(a)(ix) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product do not comply because the blister foil labels do not display the name of the sponsor or distributor, or a registered trademark that readily identifies the sponsor or distributor of the product. | supply | Over-the-counter medicines | |
| HYDROGEN PEROXIDE 3% hydrogen peroxide 3% w/v topical solution ampoule | Bridgewest Perth Pharma Pty Ltd | 11385 | CON-1145 | The consent is effective from 27 July 2023 until 31 July 2025. | 27/07/2023 | Paragraph 8(1)(i) and Subsection 9(4) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The container (ampoule) labels do not conform such that: - the name and contact details of the medicine sponsor are not correct, and - the text on the ampoule is not all oriented in the same direction | supply | Over-the-counter medicines | ||
| POVIDONE-IODINE SOLUTION 10%w/v cutaneous solution ampoule | Bridgewest Perth Pharma Pty Ltd | 12643 | CON-1144 | The consent is effective from 27 July 2023 until 31 July 2025. | 27/07/2023 | sections 8(1)(i), 8(1)(k), 8(1)(l), 8(1)(n), 9(4) and 9(7)(a)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The container (ampoule) labels do not conform with the requirements of sections 8(1)(i), 8(1)(k), 8(1)(l), 8(1)(n), 9(4) and 9(7)(a)(i) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92). | supply | Over-the-counter medicines | ||
| Probiotic Powder for Baby | Evolution Health Pty Ltd | 295986 | CON-1147 | The consent is effective from 26 July 2023 until 31 December 2023. | 26/07/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the products’ labels display the sponsor’s previous address, instead of their current address. | supply and export | Listed complementary medicines | ||
| Triple Strength Probiotic | Evolution Health Pty Ltd | 299959 | CON-1147 | The consent is effective from 26 July 2023 until 31 December 2023. | 26/07/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the products’ labels display the sponsor’s previous address, instead of their current address. | supply and export | Listed complementary medicines | ||
| Double Strength Probiotic | Evolution Health Pty Ltd | 299086 | CON-1147 | The consent is effective from 26 July 2023 until 31 December 2023. | 26/07/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the products’ labels display the sponsor’s previous address, instead of their current address. | supply and export | Listed complementary medicines | ||
| IBS Support Probiotic | Evolution Health Pty Ltd | 300447 | CON-1147 | The consent is effective from 26 July 2023 until 31 December 2023. | 26/07/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the products’ labels display the sponsor’s previous address, instead of their current address. | supply and export | Listed complementary medicines | ||
| Broad Spectrum Probiotic | Evolution Health Pty Ltd | 295982 | CON-1147 | The consent is effective from 26 July 2023 until 31 December 2023. | 26/07/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the products’ labels display the sponsor’s previous address, instead of their current address. | supply and export | Listed complementary medicines | ||
| Probiotics + Cholesterol Support | Evolution Health Pty Ltd | 362603 | CON-1147 | The consent is effective from 26 July 2023 until 31 December 2023. | 26/07/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the products’ labels display the sponsor’s previous address, instead of their current address. | supply and export | Listed complementary medicines | ||
| Children IBS Support Probiotic | Evolution Health Pty Ltd | 300448 | CON-1147 | The consent is effective from 26 July 2023 until 31 December 2023. | 26/07/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the products’ labels display the sponsor’s previous address, instead of their current address. | supply and export | Listed complementary medicines | ||
| Probiotic Powder for Children | Evolution Health Pty Ltd | 299327 | CON-1147 | The consent is effective from 26 July 2023 until 31 December 2023. | 26/07/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the products’ labels display the sponsor’s previous address, instead of their current address. | supply and export | Listed complementary medicines | ||
| Immune Support Probiotic | Evolution Health Pty Ltd | 300446 | CON-1147 | The consent is effective from 26 July 2023 until 31 December 2023. | 26/07/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the products’ labels display the sponsor’s previous address, instead of their current address. | supply and export | Listed complementary medicines | ||
| Bowel Biotic | Evolution Health Pty Ltd | 281362 | CON-1147 | The consent is effective from 26 July 2023 until 31 December 2023. | 26/07/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the products’ labels display the sponsor’s previous address, instead of their current address. | supply and export | Listed complementary medicines | ||
| Children Immune Support Probiotic | Evolution Health Pty Ltd | 300460 | CON-1147 | The consent is effective from 26 July 2023 until 31 December 2023. | 26/07/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the products’ labels display the sponsor’s previous address, instead of their current address. | supply and export | Listed complementary medicines | ||
| Shape B420 Probiotic | Evolution Health Pty Ltd | 301368 | CON-1147 | The consent is effective from 26 July 2023 until 31 December 2023. | 26/07/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the products’ labels display the sponsor’s previous address, instead of their current address. | supply and export | Listed complementary medicines | ||
| Women's Microflora Probiotic | Evolution Health Pty Ltd | 342230 | CON-1147 | The consent is effective from 26 July 2023 until 31 December 2023. | 26/07/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the products’ labels display the sponsor’s previous address, instead of their current address. | supply and export | Listed complementary medicines | ||
| Probiotic + Pregnancy & Breastfeeding | Evolution Health Pty Ltd | 351660 | CON-1147 | The consent is effective from 26 July 2023 until 31 December 2023. | 26/07/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the products’ labels display the sponsor’s previous address, instead of their current address. | supply and export | Listed complementary medicines | ||
| ZOLPIBELL Zolpidem tartrate 10 mg tablet blister pac | Generic Health Pty Ltd | 119087 | 2300691C and 2103714B | CON-1141 | The consent is effective from 26 July 2023 until the earliest date of 31 July 2025 or the expiry date of the medicine. | 26/07/2023 | Subparagraph 10(14)(a)(v) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) have the incorrect active ingredient name on the blister packs, which include the name zolpibell tartrate instead of zolpidem tartrate. | A ‘Dear Pharmacist’ letter identical to that provided to the Therapeutic Goods Administration on 24 July 2023 advising them to remind patients to keep the blister packs with the correctly labelled carton, must be provided with each of the affected batches. | import and supply | Prescription medicines |
| ALLMERCAP mercaptopurine monohydrate 20 mg/mL oral liquid suspension bottle | Link Medical Products Pty Ltd T A Link Pharmaceuticals | 213881 | CON-1157 | For all batches supplied from 24 July 2023 until 29 February 2024. | 24/07/2023 | Paragraphs 8(1)(a) and 9(1)(a), Paragraphs 8(1)(b) and 9(1)(b), Subparagraph 8(1)(j)(iv)(A), Paragraph 9(3)(a), Paragraph 8(1)(i), Paragraph 10(4)(j), Subsection 11(5). of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | • Paragraphs 8(1)(a) and 9(1)(a) that the label and the main label must include the name of the medicine; • Paragraphs 8(1)(b) and 9(1)(b) - the name(s) of all active ingredients in the medicine (where name refers to the AAN of the ingredient) • Subparagraph 8(1)(j)(iv)(A) - where: (i) a substance or substance within the group of substances referred to in Column 1 of Schedule 1 to this Order is present in the medicine; and (ii) the circumstances as set out in Column 2 of Schedule 1 exist in relation to such a substance or no circumstances are set out in Column 2; and (iii) the medicine is intended to be administered via any one or more of the route(s) of administration referred to in Column 3 of Schedule 1, then: (iv) a statement: (A) indicating that the medicine contains the substance expressed using the Name stated in Column 4 of Schedule 1; Paragraph 9(3)(a) The name of the medicine and the name(s) of active ingredient(s) on the main label must appear as a cohesive unit by the placing of the name and quantity of each active ingredient together on separate lines of text.. Paragraph 8(1)(i) -the name and contact details of the sponsor or distributor of the medicine; Paragraph 10(4)(j) - the name of the sponsor or distributor as it appears on the primary pack, or registered trademark if it readily identifies the sponsor or distributor of the medicine is required on the bottle; and Subsection 11(5) – Permitted statements of storage temperature conditions. , in that the product(s) will be supplied in the UK approved packaging which has the following differences: the name Xaluprine in place of Allmercap; the active ingredient name is referred to as mercaptopurine instead of mecaptopurine monohydrate; the name and quantity of the active ingredient are not in a cohesive unit with the name of the medicine; the storage statement is not in the permitted format; the Schedule 1 substances are not expressed as required; the sponsors name and address are not included on the label and the name of the sponsor is not included on the bottle label. | 1. A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutics Goods Administration on 7 July 2023 will be supplied with each affected batch describing the differences in the labels. 2. Sponsor details will be attached to the labels in such a way as to not impact any other relevant information on the labels. | import and supply | Prescription medicines | |
| Pfizer (Australia) CHLORHEXIDINE 0.015% Cetrimide 0.15% irrigation solution ampoule | Bridgewest Perth Pharma Pty Ltd | 57021 | CON-1140 | The consent is effective from 24 July 2023 until 31 July 2025. | 24/07/2023 | Paragraph 8(1) (i), Subsection 9(4), Subsection 9(5) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) have print direct stamped onto the plastic ampoules (TECA print) and do not comply with the requirements of TGO 91 as described in the attachment. This is due to the ampoule labels being physically unable to encompass all requirements as prescribed by TGO 91 due to limited available printable area. | supply | Prescription medicines | ||
| Pfizer (Australia) CHLORHEXIDINE 0.05% Cetrimide 0.5% irrigation solution ampoule | Bridgewest Perth Pharma Pty Ltd | 57011 | CON-1139 | The consent is effective from 24 July 2023 until 31 July 2025. | 24/07/2023 | Section 8(1) (i), Section 9(4), Section 9(5) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) have print direct stamped onto the plastic ampoules (TECA print) and do not comply with the requirements of TGO 91 as described in the attachment. This is due to the ampoule labels being physically unable to encompass all requirements as prescribed by TGO 91 due to limited available printable area. | supply | Prescription medicines | ||
| Pfizer (Australia) LIGNOCAINE HYDROCHLORIDE 1% (200 mg/20 mL) injection BP ampoule | Bridgewest Perth Pharma Pty Ltd | 49297 | CON-1138 | The consent is effective from 24 July 2023 until 31 July 2025. | 24/07/2023 | Paragraph 10(4) (f), Paragraph 10(4) (k), Subparagraph 10(15) (b) (vi) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) have print direct stamped onto the plastic ampoules (TECA print) and do not comply with the requirements of TGO 91 as described in the attachment. This is due to the ampoule labels being physically unable to encompass all requirements as prescribed by TGO 91 due to limited available printable area. | supply | Prescription medicines | ||
| Pfizer (Australia) LIGNOCAINE HYDROCHLORIDE 1% (50 mg/5 mL) injection BP ampoule | Bridgewest Perth Pharma Pty Ltd | 49296 | CON-1137 | The consent is effective from 24 July 2023 until 31 July 2025. | 24/07/2023 | Paragraph 10(4) (c), Paragraph 10(4) (d), Paragraph 10(4) (f), Paragraph 10(4) (k), Subparagraph 10(15) (b) (vi), of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) have print direct stamped onto the plastic ampoules (TECA print) and do not comply with the requirements of TGO 91 as described in the attachment. This is due to the ampoule labels being physically unable to encompass all requirements as prescribed by TGO 91 due to limited available printable area. | supply | Prescription medicines | ||
| Pfizer (Australia) LIGNOCAINE HYDROCHLORIDE 2% (400 mg/20 mL) injection BP ampoule | Bridgewest Perth Pharma Pty Ltd | 49295 | CON-1136 | The consent is effective from 24 July 2023 until 31 July 2025. | 24/07/2023 | Paragraph 10(4) (f), Paragraph 10(4) (k), SubParagraph 10(15) (b) (vi), of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) have print direct stamped onto the plastic ampoules (TECA print) and do not comply with the requirements of TGO 91 as described in the attachment. This is due to the ampoule labels being physically unable to encompass all requirements as prescribed by TGO 91 due to limited available printable area. | supply | Prescription medicines | ||
| Pfizer (Australia) LIGNOCAINE HYDROCHLORIDE 2% (100 mg/5 mL) injection BP ampoule | Bridgewest Perth Pharma Pty Ltd | 49293 | CON-1135 | The consent is effective from 24 July 2023 until 31 July 2025. | 24/07/2023 | Paragraph 10(4) (c), Paragraph 10(4) (d), Paragraph 10(4) (f), Paragraph 10(4) (k), Subparagraph 10 (15) (b) (vi), of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) have print direct stamped onto the plastic ampoules (TECA print) and do not comply with the requirements of TGO 91 as described in the attachment. This is due to the ampoule labels being physically unable to encompass all requirements as prescribed by TGO 91 due to limited available printable area. | supply | Prescription medicines | ||
| Pfizer (Australia) CHLORHEXIDINE 0.2% CATHETER PREP Irrigation Solution ampoule | Bridgewest Perth Pharma Pty Ltd | 11324 | CON-1134 | The consent is effective from 24 July 2023 until 31 July 2025. | 24/07/2023 | paragraph 8(1)(i), Subsection 9(4), Subsection 9(5), of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) have print direct stamped onto the plastic ampoules (TECA print) and do not comply with the requirements of TGO 91 as described in the attachment. This is due to the ampoule labels being physically unable to encompass all requirements as prescribed by TGO 91 due to limited available printable area. | supply | Prescription medicines | ||
| Pfizer (Australia) CHLORHEXIDINE 0.1% irrigation solution ampoule | Bridgewest Perth Pharma Pty Ltd | 11175 | CON-1133 | The consent is effective from 24 July 2023 until 31 July 2025. | 24/07/2023 | Paragraph 8(1) (i), Subsection 9(4), Subsection 9(5), of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) have print direct stamped onto the plastic ampoules (TECA print) and do not comply with the requirements of TGO 91. This is due to the ampoule labels being physically unable to encompass all requirements as prescribed by TGO 91 due to limited available printable area. | supply | Prescription medicines | ||
| Pfizer (Australia) STERILE POTASSIUM CHLORIDE CONCENTRATE potassium chloride 750 mg/10 mL injection ampoule | Bridgewest Perth Pharma Pty Ltd | 10793 | All relevant batches | CON-1132 | The consent is effective from 24 July 2023 until 1 October 2026. | 24/07/2023 | Subsection 9(4), Paragraph 10(4)(b), Paragraph 10(4)(f), Paragraph 11(2)(f), of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) do not conform to the requirements of the Therapeutics Goods Order No. 91 – Standard for labels of prescription and related medicines, in that the product(s) do not have the text KCL oriented in the same direction as other text on the label, the name of the medicine is less than 2.0mm, the term Injection is not included as part of the dosage form on the ampoule label and the active is expressed as mmol in mL not the stated weight. | supply | Prescription medicines | |
| Musculoskeletal Tissue - South Eastern Sydney Local Health District | NSW Organ and Tissue Donation Service | 230233 | CON-1131 | The consent is effective from 17 July 2023 until 1 October 2031. | 17/07/2023 | Standard for Human Cell and Tissue Products – Donor Screening Requirements (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c). of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the tissue donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980 . | 1. that the sponsor continues to monitor the literature and informs the Therapeutic Goods Administration of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Blood, tissues, and biologicals | |
| Amnion - South Eastern Sydney Local Health District | NSW Organ and Tissue Donation Service | 303207 | CON-1131 | The consent is effective from 17 July 2023 until 1 October 2031. | 17/07/2023 | Standard for Human Cell and Tissue Products – Donor Screening Requirements (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c). of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the tissue donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980 . | 1. that the sponsor continues to monitor the literature and informs the Therapeutic Goods Administration of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Blood, tissues, and biologicals | |
| Skin - South Eastern Sydney Local Health District | NSW Organ and Tissue Donation Service | 303206 | CON-1131 | The consent is effective from 17 July 2023 until 1 October 2031. | 17/07/2023 | Standard for Human Cell and Tissue Products – Donor Screening Requirements (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c). of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the tissue donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980 . | 1. that the sponsor continues to monitor the literature and informs the Therapeutic Goods Administration of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Blood, tissues, and biologicals | |
| Ocular Tissue - South Eastern Sydney Local Health District | NSW Organ and Tissue Donation Service | 232298 | CON-1131 | The consent is effective from 17 July 2023 until 1 October 2031. | 17/07/2023 | Standard for Human Cell and Tissue Products – Donor Screening Requirements (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c). of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products that do not conform to the requirements of Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c), in that the tissue donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any time on or after 1 January 1980 . | 1. that the sponsor continues to monitor the literature and informs the Therapeutic Goods Administration of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Blood, tissues, and biologicals | |
| ALLMERCAP mercaptopurine monohydrate 20 mg/mL oral liquid suspension bottle | Link Medical Products Pty Ltd T A Link Pharmaceuticals | 213881 | All batches supplied from 13 July 2023 until 29 February 2024 | CON-1130 | The consent is effective from 13 July 2023 until 29 February 2024. | 13/07/2023 | Paragraphs 8(1)(a) and 9(1)(a), Paragraphs 8(1)(b) and 9(1)(b), Subparagraph 8(1)(j)(iv)(A), Paragraph 9(3)(a), Paragraph 8(1)(i), Paragraph 10(4)(j), Subsection 11(5). of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) will be supplied in the UK approved packaging which has the following differences: the name Xaluprine in place of Allmercap; the active ingredient name is referred to as mercaptopurine instead of mecaptopurine monohydrate; the name and quantity of the active ingredient are not in a cohesive unit with the name of the medicine; the storage statement is not in the permitted format; the Schedule 1 substances aspartame and potassium sorbate are not expressed as required; the sponsors name and address are not included on the label and the name of the sponsor is not included on the bottle label | 1. A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 7 July 2023 will be supplied with each affected batch describing the differences in the labels. 2. Sponsor details will be attached to the labels in such away as to not impact any other relevant information on the labels. | import and supply | Prescription medicines |
| NIZAC nizatidine 300 mg capsule blister pack | Arrow Pharma Pty Ltd | 96963 | 7752569A,7752619A and 7752620A | CON-1128 | The consent is effective from 13 July 2023 until 30 November 2024. | 13/07/2023 | Subparagraph 8(3)(e) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) do not include the correct expiry date, that is, the date that ‘in relation to a product means the date (month and year) after which the medicine should not be used | 1. A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 6 July 2023 will be supplied with each affected batch including the updated shelf life for each batch. | supply | Prescription medicines |
| NIZAC nizatidine 150 mg capsule blister pack | Arrow Pharma Pty Ltd | 284129 | 7752556A and 7752611A | CON-1128 | The consent is effective from 13 July 2023 until 30 November 2024. | 13/07/2023 | Subparagraph 8(3)(e) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) do not include the correct expiry date, that is, the date that ‘in relation to a product means the date (month and year) after which the medicine should not be used | 1. A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 6 July 2023 will be supplied with each affected batch including the updated shelf life for each batch. | supply | Prescription medicines |
| DBL SODIUM NITRITE 0.3 g/10 mL injection BPC ampoule | Pfizer Australia Pty Ltd | 16290 | 241007 | CON-1129 | The consent is effective from 12 July 2023 until 30 September 2024. | 12/07/2023 | The USP-NF Sodium Nitrite Injection monograph requirements for Assay and Related substances. of United States Pharmacopoeia | The product is not tested as per the requirements of the monograph, as assay is tested by titration and there is no related substance method as per the USP-NF requirements | import and supply | Prescription medicines | |
| AMCAL MOMETASONE ALLERGY RELIEF NASAL SPRAY mometasone furoate (as monohydrate) 50 mcg/actuation suspension bottle | Neo Health OTC Pty Ltd | 345371 | CON-1127 | The consent is effective from 12 July 2023 until 31 December 2023. | 12/07/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The labels do not include certain required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (RASML No. 6). | import and supply | Over-the-counter medicines | ||
| TERRYWHITE CHEMMART MOMETASONE ALLERGY RELIEF mometasone furoate 50 mcg/actuation (as monohydrate) suspension spray bottle | Neo Health OTC Pty Ltd | 312273 | CON-1127 | The consent is effective from 12 July 2023 until 31 December 2023. | 12/07/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The labels do not include certain required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (RASML No. 6). | import and supply | Over-the-counter medicines | ||
| PRICELINE PHARMACY MOMETASONE ALLERGY RELIEF mometasone furoate (as monohydrate) 50 mcg/ actuation suspension nasal spray bottle | Neo Health OTC Pty Ltd | 285064 | CON-1127 | The consent is effective from 12 July 2023 until 31 December 2023. | 12/07/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The labels do not include certain required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (RASML No. 6). | import and supply | Over-the-counter medicines | ||
| PHARMACY HEALTH MOMETASONE ALLERGY RELIEF mometasone furoate (as monohydrate) 50 mcg/ actuation suspension nasal spray bottle | Neo Health OTC Pty Ltd | 285063 | CON-1127 | The consent is effective from 12 July 2023 until 31 December 2023. | 12/07/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The labels do not include certain required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (RASML No. 6). | import and supply | Over-the-counter medicines | ||
| NUROFEN MELTLETS BERRY BURST ibuprofen 200 mg orally disintegrating tablets blister pack | Reckitt Benckiser Pty Ltd | 373074 | MS778, NS148, MX532, MN904, MX815, NA401, MS770, MN904, MS779 | CON-1126 | The consent is effective from 7 July 2023 until 1 December 2024. | 7/07/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The labels do not use correct wording for certain required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (RASML No. 6) | supply | Registered complementary medicines | |
| NUROFEN FOR CHILDREN 7+ YEARS Orange Flavour ibuprofen 100 mg soft chewable capsules blister pack | Reckitt Benckiser Pty Ltd | 265278 | NL980 | CON-1126 | The consent is effective from 7 July 2023 until 1 December 2024. | 7/07/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The labels do not use correct wording for certain required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (RASML No. 6) | supply | Registered complementary medicines | |
| ATGAM equine antithymocyte immunoglobulin 250 mg/5 mL injection ampoule | Pfizer Australia Pty Ltd | 12282 | GY8471 | CON-1124 | The consent is effective from 29 June 2023 until 1 November 2023. | 29/06/2023 | Section 8(1)(o) Section 8(1)(b), Section 9(1)(b) & Section 10(4)(d) Section 11(2)(f)(v) Section 10(3)(a) Section 8(1)(d) Section 9(1)(g) Section 10(3)(b) Section 9(1)(e) Section 10(4)(f) Section 10(4)(h) and (i) Section 10(4)(j) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | - Name of the medicine is not stated on at least 3 non opposing sides of the carton. - Active ingredient is expressed differently to the AAN in the ARTG Entry. - Proportion of active ingredient is expressed differently. - The name and quantity of excipients are not all stated and expressed as nominal mass in the stated volume of fill of the injection in the container. - Dosage form, 'Injection, solution' is expressed differently, - 'for infusion’ is not displayed adjacent to the name of the dosage form. - Statement regarding use in one patient on one occasion only and contains no antimicrobial preservative is missing. - Quantity of the medicine is not stated on the main label of the carton, however, is stated on other panels of the carton. - Dosage form, 'injection, solution' is not stated on the ampoule label. - Batch and expiry details is not immediately preceded by the batch number prefix on the ampoule label. - Incorrect sponsor detail is on the ampoule label; however, ‘Pfizer’ is mentioned. | 1. The Sponsor is required to over sticker the US product carton with the Australian sponsor details, the AUST R number, signal headings and a direction to not administer the product undiluted. 2. A ‘Dear Healthcare Professional’ letter will be supplied with the affected batch warning that the product is a US-labelled product supplied with section 14 consent. | import and supply | Prescription medicines |
| Ocular Tissue - Lions Eye Donation Service | Lions Eye Donation Service | 234997 | CON-1122 | The consent is effective from 26 June 2023 until 1 October 2031. | 26/06/2023 | Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c). of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products will not comply with the requirement of indefinite geographical deferral for variant Creutzfeldt-Jakob disease (vCJD) risk, applicable to tissue donors having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or receiving a transfusion or injection of blood or blood components while in the UK at any time on or after 1 January 1980. | 1. That the sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Blood, tissues, and biologicals | |
| Ocular Tissue - Southern Adelaide Local Health Network T/a Flinders Medical Centre | Eye Bank of South Australia | 235477 | CON-1123 | The consent is effective from 20 June 2023 until 1 October 2031. | 20/06/2023 | Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products will not comply with the requirement of indefinite geographical deferral for variant Creutzfeldt-Jakob disease (vCJD) risk, applicable to tissue donors having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or receiving a transfusion or injection of blood or blood components while in the UK at any time on or after 1 January 1980. | The sponsor continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | supply | Blood, tissues, and biologicals | |
| Ocular Tissue - Lions Eye Bank of Western Australia | Lions Eye Bank of WA | 239107 | CON-1120 | The consent is effective from 20 June 2023 until 1 October 2031. (the sunset date of TGO 108) | 20/06/2023 | Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products will not comply with the requirement of indefinite geographical deferral for variant Creutzfeldt-Jakob disease (vCJD) risk, applicable to tissue donors having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996 or receiving a transfusion or injection of blood or blood components while in the UK at any time on or after 1 January 1980. | 1. that the sponsor continues to monitor the literature and informs the Therapeutic Goods Administration of any new evidence that substantively alters the estimated risks, such that they become unacceptable | supply | Blood, tissues, and biologicals | |
| MALTOFER Tablets | Vifor Pharma Pty Ltd | 229647 | CON-1119 | The consent is effective from 20 June 2023 until 20 June 2025. | 20/06/2023 | paragraphs 10 (8)(a)(v), 10 (8)(a)(vi) and 10 (8)(a)(vii) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | • The name on the proposed blister label is ‘Maltofer’, instead of Therapeutic Goods Administration (TGA) approved product name ‘Maltofer Tablets’. • The name of the active ingredient on the proposed blister label is ‘iron as iron (III)-hydroxide polymaltose complex (IPC)’, instead of ‘iron as iron polymaltose’ on the TGA approved blister label. • The quantity of iron on the proposed blister label is depicted as 100 mg, instead of 100 mg iron as 370 mg iron polymaltose presented on the TGA approved blister label. | import and supply | Over-the-counter medicines | ||
| IMIGRAN FDT sumatriptan 50 mg (as succinate) tablet blister pack | Aspen Pharmacare Australia Pty Ltd | 106714 | CON-1121 | The consent is effective from 16 June 2023 until 1 January 2024. | 16/06/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the carton labels for the 2 tablets pack size do not include certain required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (RASML No. 6) | supply | Over-the-counter medicines | ||
| IMIGRAN sumatriptan 50 mg (as succinate) tablet blister pack | Aspen Pharmacare Australia Pty Ltd | 52261 | CON-1121 | The consent is effective from 16 June 2023 until 1 January 2024. | 16/06/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the carton labels for the 2 tablets pack size do not include certain required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (RASML No. 6) | supply | Over-the-counter medicines | ||
| AVAGARD ANTISEPTIC CHG HAND RUB solution bottle | 3M Australia Pty Ltd | 77398 | CON-1118 | The consent is effective from 16 June 2023 until 1 January 2024. | 16/06/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The carton labels do not include certain required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (RASML No. 6). Specifically, the labels do not include the statements “Seek immediate medical assistance if this occurs” and “Mild skin irritation may occur; stop use if it becomes more severe.” and instead state “Severe allergic reactions can occur. Stop use if this occurs”. | supply | Over-the-counter medicines | ||
| AVAGARD ANTISEPTIC HAND AND BODY WASH chlorhexidine gluconate 2% w/w solution bottle | 3M Australia Pty Ltd | 176112 | CON-1117 | The consent is effective from 16 June 2023 until 1 December 2023. | 16/06/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The carton labels do not include certain required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (RASML No. 6). Specifically, the labels do not include the statements “Seek immediate medical assistance if this occurs” and “Mild skin irritation may occur; stop use if it becomes more severe.” and instead state “Severe allergic reactions can occur. Stop use if this occurs”. | supply | Over-the-counter medicines | ||
| AVAGARD ANTISEPTIC SURGICAL HAND SCRUB chlorhexidine gluconate 4% w/w solution bottle | 3M Australia Pty Ltd | 176111 | CON-1116 | The consent is effective from 16 June 2023 until 1 June 2024. | 16/06/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The carton labels do not include certain required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (RASML No. 6). Specifically, the labels do not include the statements “Seek immediate medical assistance if this occurs” and “Mild skin irritation may occur; stop use if it becomes more severe.” and instead state “Severe allergic reactions can occur. Stop use if this occurs”. | supply | Over-the-counter medicines | ||
| NUROFEN MELTLETS BERRY BURST ibuprofen 200 mg orally disintegrating tablets blister pack | Reckitt Benckiser Pty Ltd | 373074 | MH503, ML594, MN342, MS772, MZ615, ND982, NE693, NM806, NS149, MS780, MX482, MX712, MZ613, MZ614, MZ616, ND313, ND980, NJ031, NJ808, NN889, NV272, | CON-1113 | The consent is effective from 8 June 2023 until 1 December 2024. | 8/06/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product labels display the RASML 5 advisory statements “Unless a doctor has told you to do not use in children under 7 years” or “Unless a doctor has told you to do not use in children under 12 years” instead of the advisory statements required by RASML 6 “Do not use in children under 7 years” or “Do not use in children under 12 years”, as relevant to the product. | supply | Over-the-counter medicines | |
| NUROFEN QUICKZORB ibuprofen lysine 342 mg tablet blister pack | Reckitt Benckiser Pty Ltd | 96215 | NJ256, NL141, NR180, NW034, NN055, NN974, NW205, | CON-1113 | The consent is effective from 8 June 2023 until 1 December 2024. | 8/06/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product labels display the RASML 5 advisory statements “Unless a doctor has told you to do not use in children under 7 years” or “Unless a doctor has told you to do not use in children under 12 years” instead of the advisory statements required by RASML 6 “Do not use in children under 7 years” or “Do not use in children under 12 years”, as relevant to the product. | 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 | NB589, NM026, NN307, NN313 | CON-1113 | The consent is effective from 8 June 2023 until 1 December 2024. | 8/06/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product labels display the RASML 5 advisory statements “Unless a doctor has told you to do not use in children under 7 years” or “Unless a doctor has told you to do not use in children under 12 years” instead of the advisory statements required by RASML 6 “Do not use in children under 7 years” or “Do not use in children under 12 years”, as relevant to the product. | supply | Over-the-counter medicines | |
| Nurofen Caplets ibuprofen 200 mg capsule shaped tablet blister pack | Reckitt Benckiser Pty Ltd | 127287 | ND893, ND894, NR109, NA343, NM443, NM826, NT140, NR631, NV439 | CON-1113 | The consent is effective from 8 June 2023 until 1 December 2024. | 8/06/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product labels display the RASML 5 advisory statements “Unless a doctor has told you to do not use in children under 7 years” or “Unless a doctor has told you to do not use in children under 12 years” instead of the advisory statements required by RASML 6 “Do not use in children under 7 years” or “Do not use in children under 12 years”, as relevant to the product. | supply | Over-the-counter medicines | |
| NUROFEN ibuprofen 200 mg tablet blister pack | Reckitt Benckiser Pty Ltd | 127272 | NW109, NJ922, NL574, NR555, NN321, NG528, NG542, NM436, NM829, NR335, NS879 | CON-1113 | The consent is effective from 8 June 2023 until 1 December 2024. | 8/06/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product labels display the RASML 5 advisory statements “Unless a doctor has told you to do not use in children under 7 years” or “Unless a doctor has told you to do not use in children under 12 years” instead of the advisory statements required by RASML 6 “Do not use in children under 7 years” or “Do not use in children under 12 years”, as relevant to the product. | supply | Over-the-counter medicines | |
| NUROFEN ZAVANCE LIQUID CAPSULES ibuprofen 200 mg soft capsule blister pack | Reckitt Benckiser Pty Ltd | 163477 | NJ809, NM937, NV096 | CON-1113 | The consent is effective from 8 June 2023 until 1 December 2024. | 8/06/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product labels display the RASML 5 advisory statements “Unless a doctor has told you to do not use in children under 7 years” or “Unless a doctor has told you to do not use in children under 12 years” instead of the advisory statements required by RASML 6 “Do not use in children under 7 years” or “Do not use in children under 12 years”, as relevant to the product. | supply | Over-the-counter medicines | |
| NUROFEN ZAVANCE 256 mg ibuprofen sodium sugar coated capsule shaped tablet blister pack | Reckitt Benckiser Pty Ltd | 156294 | NM444, NR644, NX982, NW111, NG527, NR645, NS877 | CON-1113 | The consent is effective from 8 June 2023 until 1 December 2024. | 8/06/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product labels display the RASML 5 advisory statements “Unless a doctor has told you to do not use in children under 7 years” or “Unless a doctor has told you to do not use in children under 12 years” instead of the advisory statements required by RASML 6 “Do not use in children under 7 years” or “Do not use in children under 12 years”, as relevant to the product. | supply | Over-the-counter medicines | |
| NUROFEN ZAVANCE 256 mg ibuprofen sodium sugar coated tablet blister pack | Reckitt Benckiser Pty Ltd | 156293 | NR020, NR639, NB605, NM441, NN322, NX359 | CON-1113 | The consent is effective from 8 June 2023 until 1 December 2024. | 8/06/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product labels display the RASML 5 advisory statements “Unless a doctor has told you to do not use in children under 7 years” or “Unless a doctor has told you to do not use in children under 12 years” instead of the advisory statements required by RASML 6 “Do not use in children under 7 years” or “Do not use in children under 12 years”, as relevant to the product. | supply | Over-the-counter medicines | |
| VELTASSA patiromer (as sorbitex calcium)16.8 g powder for oral suspension sachet | Vifor Pharma Pty Ltd | 281014 | 221268 | CON-1112 | The consent is effective from 5 June 2023 until the stated batch is exhausted or 31 August 2025. | 5/06/2023 | Paragraph 7 (2)(b) Subparagraph 10(13)(a)(v) Subparagraph 10(13)(a)(vi) Subparagraph 10(13)(a)(x) Subsection 11 (5) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product does not comply because the sachet labels: - Contain information in multiple languages; - The product name of the medicines and the name of the active ingredients are not presented as they appear in the ARTG entry; - The Sponsor name is recorded as Vifor Fresenius Medical Care Renal Pharma France; and - The storage conditions say “Store in refrigerator. Can be stored below 25°C for up to 6 months”. | 1. A Dear End User letter identical to that provided to the Therapeutic Goods Administration on 5 June 2023 will be supplied in the product carton describing the changes. | import and supply | Prescription medicines |
| Vitamin C | Procter & Gamble Australia Pty Ltd | 313180 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Collagen | Procter & Gamble Australia Pty Ltd | 318054 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Hydrate Orange | Procter & Gamble Australia Pty Ltd | 321236 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Vitamin D | Procter & Gamble Australia Pty Ltd | 322266 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Iron + Vitamin C | Procter & Gamble Australia Pty Ltd | 324166 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Magnesium | Procter & Gamble Australia Pty Ltd | 325773 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Performance | Procter & Gamble Australia Pty Ltd | 326346 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Hydrate Apple + Berry | Procter & Gamble Australia Pty Ltd | 326355 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Sport Lemon + Lime | Procter & Gamble Australia Pty Ltd | 327124 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Sport Orange | Procter & Gamble Australia Pty Ltd | 327132 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Sport Berry | Procter & Gamble Australia Pty Ltd | 327133 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Magnesium Forte | Procter & Gamble Australia Pty Ltd | 329278 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Energy | Procter & Gamble Australia Pty Ltd | 330143 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Vitamin B+ | Procter & Gamble Australia Pty Ltd | 330981 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Kids Immunity | Procter & Gamble Australia Pty Ltd | 339911 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Kids Multivitamin | Procter & Gamble Australia Pty Ltd | 340864 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Multivitamin | Procter & Gamble Australia Pty Ltd | 341699 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Immunity Orange Zest | Procter & Gamble Australia Pty Ltd | 343585 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Mega B Complex | Procter & Gamble Australia Pty Ltd | 346336 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Calcium Plus | Procter & Gamble Australia Pty Ltd | 346494 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Zinc Plus | Procter & Gamble Australia Pty Ltd | 347980 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Vitamin C Elderberry Flavour | Procter & Gamble Australia Pty Ltd | 366796 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Hydrate Lemon + Lime | Procter & Gamble Australia Pty Ltd | 371178 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Kids Calcium | Procter & Gamble Australia Pty Ltd | 371179 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Multivitamin Berry | Procter & Gamble Australia Pty Ltd | 371992 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Energy Raspberry | Procter & Gamble Australia Pty Ltd | 371993 | CON-1110 | The consent is effective from 31 May 2023 until 1 June 2024. | 31/05/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the product labels do not bear the name and contact details of sponsor, instead the labels bear the name and contact details of the previous sponsor VitaminHaus Pty Ltd. | There must be arrangements in place with Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia Pty Ltd [the current sponsor]. | supply | Listed complementary medicines | |
| Plasma for fractionation | Australian Red Cross Lifeblood | CON-1111 | The consent is effective from 25 May 2023 until 1 October 2031. (when TGO 108 sunsets) | 25/05/2023 | Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order 2021; Part 2 Section 10 (9) , particularly Item 12 in Schedule 1 of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The product will be collected from donors which do not comply with these requirements for donor deferral but will be able to be collected from anyone reporting the following activities in the past 3-months: • for male donors: male-to-male sex • for female donors: sex with a man who has ever had sex with a man • for transgender donors: sexual contact with a male • sex work • sexual contact with a sex worker (male or female) • overseas sexual contact with a resident of a HIV high prevalence country • sexual contact with a new partner from a HIV high prevalence country • sexual contact with an injecting drug user (current or past) but does not include the current deferral for sexual contact with a partner known to be infected with a blood-borne virus (HIV, HBV, HCV or HTLV) i.e. this deferral with be maintained. | 1. That Lifeblood continues to monitor the literature and informs the Therapeutics Goods Administration of any new evidence that substantively alters the estimated risks, such that they become unacceptable. 2. That Lifeblood does not implement the change for plasma for fractionation until CSL Behring (CSLB) have submitted a variation to Therapeutics Goods Administration for the change and subsequently received approval from Therapeutics Goods Administration for the change. | supply | Blood, tissues, and biologicals | ||
| Plasma for fractionation only | Australian Red Cross Lifeblood | CON-1109 | The consent is effective from 25 May 2023 until 1 April 2029. (when TGO 102 sunsets) | 25/05/2023 | 19th edition; Standards for selection of donors, Chapter 2, section 4, table 2.1 of Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019 | The product will be collected from donors which do not comply with these requirements for donor deferral but will be able to be collected from anyone reporting the following activities in the past 3-months: • for male donors: male-to-male sex • for female donors: sex with a man who has ever had sex with a man • for transgender donors: sexual contact with a male • sex work • sexual contact with a sex worker (male or female) • overseas sexual contact with a resident of a HIV high prevalence country • sexual contact with a new partner from a HIV high prevalence country • sexual contact with an injecting drug user (current or past) but does not include the current deferral for sexual contact with a partner known to be infected with a blood-borne virus (HIV, HBV, HCV or HTLV) i.e. this deferral with be maintained. | 1. That Lifeblood continues to monitor the literature and informs the Therapeutics Goods Administration of any new evidence that substantively alters the estimated risks, such that they become unacceptable. 2. That Lifeblood does not implement the change for plasma for fractionation until CSL Behring (CSLB) have submitted a variation to Therapeutics Goods Administration for the change and subsequently received approval from Therapeutics Goods Administration for the change. | supply | Blood, tissues, and biologicals | ||
| COARTEM 20 mg /120 mg artemether/lumefantrine 20 mg/120 mg dispersible tablet blister pack | Novartis Pharmaceuticals Australia Pty Ltd | 158527 | Batches released for supply before 30 April 2025 | CON-1108 | The consent is effective from 25 May 2023 until 30 April 2025. | 25/05/2023 | Paragraph 8(1)(a), Paragraph 8(1)(h), Paragraph 8(1)(i), Paragraph 8(1)(j), Paragraph 8(1)(k), Paragraph 8(1)(o), Subsection 8(2). of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product labels are international labels and are not Australia-specific | 1. a ‘Dear Healthcare Professional’ letter identical to that provided to the Therapeutic Goods Administration on 2 September 2020, will be supplied with each affected batch. 2. The ARTG number and the quantity of the medicine will be over-stickered onto the carton labels | import and supply | Prescription medicines |
| RIAMET 20 mg/120 mg artemether/lumefantrine 20 mg/120 mg dispersible tablet blister pack | Novartis Pharmaceuticals Australia Pty Ltd | 158523 | Batches released for supply before 30 April 2025 | CON-1108 | The consent is effective from 25 May 2023 until 30 April 2025. | 25/05/2023 | Paragraph 8(1)(a), Paragraph 8(1)(h), Paragraph 8(1)(i), Paragraph 8(1)(j), Paragraph 8(1)(k), Paragraph 8(1)(o), Subsection 8(2). of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product labels are international labels and are not Australia-specific | 1. a ‘Dear Healthcare Professional’ letter identical to that provided to the Therapeutic Goods Administration on 2 September 2020, will be supplied with each affected batch. 2. The ARTG number and the quantity of the medicine will be over-stickered onto the carton labels | import and supply | Prescription medicines |
| MAXALT MIGRAINE RELIEF rizatriptan 5 mg (as benzoate) wafer blister pack | ORGANON PHARMA PTY LTD | 407853 | 5109201 | CON-1106 | The consent is effective from 18 May 2023 until 25 April 2024. | 18/05/2023 | paragraphs 8(1)(a), 9(1)(a) and 10(8)(a)(vi) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product does not comply because the medicine name on the foil blister and the sachet labels is slightly different to the approved name included in the Australian Register of Therapeutic Goods and the foil blister label displays the name of the active ingredient as rizatriptan instead of rizatriptan (as benzoate). | supply | Over-the-counter medicines | |
| donor for blood, tissues and biologicals | Australian Red Cross Lifeblood | CON-1102 | The consent is effective from 9 May 2023 until 1 October 2031. (when TGO 108 sunsets) | 9/05/2023 | (TGO 108) Order 2021; Part 2 Section 10 (9); Schedule 1 – Ineligibility criteria for donor selection Item 10 (c)-Period of ineligibility (a) or (b) or (c). of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | Donors of fresh blood and blood products who have a tattoo performed at a licensed/registered tattoo parlour or cosmetic clinic in Australia, can donate after a 7-day deferral period from the time of the last tattoo procedure | Continuation of the policy of deferring donors who have a tattoo performed outside Australia or performed in an unregistered premise e.g. home/backyard tattoo, from donation for 4 months from the date of the last procedure | supply | Blood, tissues, and biologicals | ||
| Blood and blood components | Australian Red Cross Lifeblood | CON-1101 | The consent is effective from 9 May 2023 until 1 April 2029. (when TGO 102 sunsets) | 9/05/2023 | Council of Europe Guide to the Preparation, Use and Quality Assurance of Blood Components 19th edition; Standards for selection of donors, Chapter 2, section 4, table 2.2: Condition: tattooing. of Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019 | Donors of fresh blood and blood products who have a tattoo performed at a licensed/registered tattoo parlour or cosmetic clinic in Australia, can donate after a 7-day deferral period from the time of the last tattoo procedure | Continuation of the policy of deferring donors who have a tattoo performed outside Australia or performed in an unregistered premise e.g. home/backyard tattoo, from donation for 4 months from the date of the last procedure | supply | Blood, tissues, and biologicals | ||
| DEXAMETHASONE MYLAN dexamethasone phosphate (as dexamethasone sodium phosphate) 8mg/2mL solution for injection vial | Alphapharm Pty Ltd | 163199 | CON-1105 | The consent is effective from 8 May 2023 until 30 June 2024. | 8/05/2023 | The product does not meet the pH requirements in the monograph for Dexamethasone Sodium Phosphate Injection of British Pharmacopoeia | Does not meet the pH requirements in the monograph | 1. 'Dear Healthcare Provider’ letters identical to those provided to the Therapeutic Goods Administration on 24 April 2023 will be supplied with each affected batch; 2. The Therapeutics Goods Administration must be informed immediately by writing to the decision delegate if any batch of the product(s) is analysed and the results obtained for pH are greater than or equal to pH 9.0. | import and supply | Prescription medicines | |
| DEXAMETHASONE VIATRIS dexamethasone phosphate (as dexamethasone sodium phosphate) 8 mg/2 mL solution for injection vial | Alphapharm Pty Ltd | 163199 | CON-1105 | The consent is effective from 8 May 2023 until 30 June 2024. | 8/05/2023 | The product does not meet the pH requirements in the monograph for Dexamethasone Sodium Phosphate Injection of British Pharmacopoeia | Does not meet the pH requirements in the monograph | 1. 'Dear Healthcare Provider’ letters identical to those provided to the Therapeutic Goods Administration on 24 April 2023 will be supplied with each affected batch; 2. The Therapeutics Goods Administration must be informed immediately by writing to the decision delegate if any batch of the product(s) is analysed and the results obtained for pH are greater than or equal to pH 9.0. | import and supply | Prescription medicines | |
| PANADOL CHILDREN 1 - 5 YEARS paracetamol 24 mg/mL oral suspension bottle (Strawberry - Colourfree) | Haleon Australia Pty Ltd | 178300 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL OPTIZORB (caplets) paracetamol 500 mg film coated tablet blister pack | Haleon Australia Pty Ltd | 160821 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| ZOVIRAX aciclovir 5% w/w cream bottle (reformulation) | Haleon Australia Pty Ltd | 150099 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| ZOVIRAX aciclovir 5% w/w cream tube (reformulation 2) | Haleon Australia Pty Ltd | 150098 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| OTRIVIN MENTHOL xylometazoline hydrochloride 1 mg/mL nasal spray pump actuated metered dose aerosol | Haleon Australia Pty Ltd | 99690 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| Centrum Kids BRAIN FUEL | Haleon Australia Pty Ltd | 386813 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum Kids IMMUNE FUEL | Haleon Australia Pty Ltd | 385794 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum Kids MULTI FUEL | Haleon Australia Pty Ltd | 389277 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum Kids VISION FUEL | Haleon Australia Pty Ltd | 385729 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Sensodyne Extra Fresh Complete Care+ Smart Clean | Haleon Australia Pty Ltd | 384096 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Sensodyne Cool Mint Complete Care + Smart Clean | Haleon Australia Pty Ltd | 384095 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum VISION & EYE HEALTH | Haleon Australia Pty Ltd | 383713 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum MOOD & IMMUNE SUPPORT | Haleon Australia Pty Ltd | 383712 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum BEAUTIFUL & BRIGHT | Haleon Australia Pty Ltd | 351921 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum CALM & COLLECTED | Haleon Australia Pty Ltd | 351912 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum MIND & MEMORY | Haleon Australia Pty Ltd | 348511 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum IMMUNE DEFENCE & RECOVERY | Haleon Australia Pty Ltd | 437415 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum MOVEMENT & MOBILTY | Haleon Australia Pty Ltd | 347414 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Chapstick Classic | Haleon Australia Pty Ltd | 344724 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Chapstick Strawberry | Haleon Australia Pty Ltd | 344721 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Chapstick Conditioner | Haleon Australia Pty Ltd | 344717 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| SENSODYNE Deep Clean Daily Care | Haleon Australia Pty Ltd | 344495 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| SENSODYNE Daily Care + Whitening Toothpaste | Haleon Australia Pty Ltd | 344494 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| SENSODYNE Daily Care Toothpaste | Haleon Australia Pty Ltd | 344490 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum Kids Strawberry | Haleon Australia Pty Ltd | 320154 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum REST & RENEW | Haleon Australia Pty Ltd | 318746 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum COLLAGEN BOOST & GLOW | Haleon Australia Pty Ltd | 318729 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Caltrate Vitamin D Daily | Haleon Australia Pty Ltd | 315416 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum for Men 50+ | Haleon Australia Pty Ltd | 293186 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum for Women 50+ | Haleon Australia Pty Ltd | 293185 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum for Women | Haleon Australia Pty Ltd | 293159 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum for Men | Haleon Australia Pty Ltd | 293158 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Caltrate Bone Health | Haleon Australia Pty Ltd | 214784 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Caltrate Bone & Muscle | Haleon Australia Pty Ltd | 214783 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Caltrate 600 mg | Haleon Australia Pty Ltd | 196980 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Caltrate Bone & Muscle 50+ Years | Haleon Australia Pty Ltd | 196979 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum Advance | Haleon Australia Pty Ltd | 193683 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum Advance 50+ | Haleon Australia Pty Ltd | 193642 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Macleans Sensitive Fresh Mint | Haleon Australia Pty Ltd | 172102 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| Centrum Kids Incremin Iron Mixture | Haleon Australia Pty Ltd | 167627 | CON-1104 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of GlaxoSmithKline Consumer Healthcare (previous sponsor name) instead of Haleon Australia Pty Ltd (current sponsor name). | import and supply | Listed complementary medicines | ||
| PANADOL CHILDREN 1 - 5 YEARS paracetamol 24 mg/mL oral suspension bottle (Orange - Colourfree) | Haleon Australia Pty Ltd | 178301 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL CHILDREN 5 - 12 YEARS paracetamol 48 mg/mL oral suspension bottle (Strawberry - Colourfree) | Haleon Australia Pty Ltd | 178302 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL CHILDREN 5 - 12 YEARS paracetamol 48 mg/mL oral suspension bottle (Orange - Colourfree) | Haleon Australia Pty Ltd | 178303 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| NICABATE GUM nicotine 4 mg Extra Fresh Mint Flavour coated chewing gum blister pack | Haleon Australia Pty Ltd | 258233 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| Panadol Suppositories paracetamol 500 mg blister pack | Haleon Australia Pty Ltd | 332712 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| NICABATE MINI LOZENGES nicotine 4 mg (as polacrilex) mint flavour lozenge tube (new formulation) | Haleon Australia Pty Ltd | 392046 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| NICABATE MINI LOZENGES nicotine 2 mg (as polacrilex) mint flavour lozenge tube | Haleon Australia Pty Ltd | 392045 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL OPTIZORB paracetamol 500 mg film coated round tablet blister pack (reformulation) | Haleon Australia Pty Ltd | 356022 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL OPTIZORB paracetamol 500 mg film coated capsule shaped tablet blister pack (reformulation) | Haleon Australia Pty Ltd | 356011 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| Panadol Children Suppositories 5 to 12 Years paracetamol 250 mg blister pack | Haleon Australia Pty Ltd | 332714 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| Panadol Children Suppositories 6 Months to 5 Years paracetamol 125 mg blister pack | Haleon Australia Pty Ltd | 332713 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL RAPID paracetamol 500mg tablet blister pack (reformulation) | Haleon Australia Pty Ltd | 332528 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| NEXIUM 24HR ONCE DAILY DOSING esomeprazole 20 mg (as magnesium trihydrate) capsule | Haleon Australia Pty Ltd | 316501 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| ADVIL ibuprofen 200 mg soft capsule bottle | Haleon Australia Pty Ltd | 311280 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| VOLTAREN EMULGEL NO MESS APPLICATOR diclofenac diethylamine 11.6 mg/g gel tube | Haleon Australia Pty Ltd | 282516 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| ZOVIRAX DUO cream tube | Haleon Australia Pty Ltd | 281884 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL OSTEO (reformulation) paracetamol 665 mg modified release tablet blister pack | Haleon Australia Pty Ltd | 260264 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| NICABATE GUM nicotine 2 mg Extra Fresh Mint Flavour coated chewing gum blister pack | Haleon Australia Pty Ltd | 258232 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| NEXIUM 24HR ONCE DAILY DOSING esomeprazole 20 mg (as magnesium trihydrate) tablet blister pack | Haleon Australia Pty Ltd | 231439 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| VOLTAREN OSTEO GEL 12 HOURLY diclofenac diethylamine 23.2 mg/g gel tube | Haleon Australia Pty Ltd | 219514 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL EXTRA (reformulation) film-coated tablet blister pack | Haleon Australia Pty Ltd | 203990 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL OPTIZORB (tablets) paracetamol 500 mg film coated tablet blister pack | Haleon Australia Pty Ltd | 186245 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| ADVIL CHILDREN 7-12 YEARS PAIN & FEVER RELIEF ibuprofen 100 mg chewable tablet bottle | Haleon Australia Pty Ltd | 178662 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| ADVIL CHILDREN 2-12 YEARS PAIN & FEVER RELIEF ibuprofen 100 mg/5 mL oral liquid suspension bottle | Haleon Australia Pty Ltd | 178433 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| ADVIL INFANT 3 MONTHS - 2 YEARS PAIN & FEVER RELIEF ibuprofen 40 mg/mL oral liquid suspension bottle | Haleon Australia Pty Ltd | 178432 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| OTRIVIN PLUS NASAL SPRAY pump actuated metered dose aerosol | Haleon Australia Pty Ltd | 178401 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| NICABATE P nicotine 21 mg/24 hours Transdermal Drug Delivery System sachet | Haleon Australia Pty Ltd | 171308 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| VOLTAREN RAPID 12.5 LIQUID CAPSULE diclofenac potassium 12.5 mg soft capsule blister pack | Haleon Australia Pty Ltd | 171307 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| VOLTAREN RAPID 12.5 diclofenac potassium 12.5 mg film coated tablet blister pack (reformulation) | Haleon Australia Pty Ltd | 168061 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL NIGHT capsule-shaped tablet blister pack (reformulation) | Haleon Australia Pty Ltd | 167596 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL CHILDREN CHEWABLE 7+ YEARS paracetamol 120 mg chewable tablet blister pack | Haleon Australia Pty Ltd | 159903 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL CHILDREN CHEWABLE 3+ YEARS paracetamol 120 mg chewable tablet blister pack | Haleon Australia Pty Ltd | 159902 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| ROBITUSSIN COLD & CHESTY COUGH oral liquid bottle | Haleon Australia Pty Ltd | 157799 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL COLD & FLU PLUS DECONGESTANT capsule-shaped tablet blister pack | Haleon Australia Pty Ltd | 156874 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| NICABATE MINI LOZENGES nicotine 1.5 mg Mint Flavour lozenge tube | Haleon Australia Pty Ltd | 156603 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| NICABATE MINI LOZENGES nicotine 4 mg Mint Flavour lozenge tube | Haleon Australia Pty Ltd | 156604 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| OTRIVIN JUNIOR NASAL SPRAY xylometazoline hydrochloride 0.5 mg/mL pump actuated metered dose aerosol | Haleon Australia Pty Ltd | 142227 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| OTRIVIN ADULT NASAL SPRAY xylometazoline hydrochloride 1mg/mL pump actuated metered dose aerosol (reformulation) | Haleon Australia Pty Ltd | 142197 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| LAMISIL ONCE terbinafine 10 mg/g (as hydrochloride) collodion tube | Haleon Australia Pty Ltd | 124887 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL OSTEO paracetamol 665 mg modified release tablet blister pack | Haleon Australia Pty Ltd | 116619 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| ADVIL ibuprofen 200 mg tablet blister pack | Haleon Australia Pty Ltd | 104221 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| ROBITUSSIN CHESTY COUGH guaifenesin 20 mg/mL oral liquid bottle | Haleon Australia Pty Ltd | 98291 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| ADVIL ibuprofen 200mg soft capsule blister pack | Haleon Australia Pty Ltd | 97229 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL CHILDREN 1 MONTH - 1 YEAR paracetamol 100 mg/mL oral liquid bottle | Haleon Australia Pty Ltd | 83363 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| NICABATE CLEAR PATCH nicotine 21 mg/24 hours transdermal drug delivery system sachet | Haleon Australia Pty Ltd | 81035 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| NICABATE CLEAR PATCH nicotine 14 mg/24 hours transdermal drug delivery system sachet | Haleon Australia Pty Ltd | 81034 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| NICABATE CLEAR PATCH nicotine 7 mg/24 hours transdermal drug delivery system sachet | Haleon Australia Pty Ltd | 81033 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL MINI CAPS paracetamol 500 mg tablet blister pack | Haleon Australia Pty Ltd | 81007 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| ROBITUSSIN CHESTY COUGH FORTE oral liquid bottle (reformulation) | Haleon Australia Pty Ltd | 76032 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| FLIXONASE ALLERGY & HAYFEVER 24 HOUR fluticasone propionate 50 ug/actuation aqueous nasal spray bottle | Haleon Australia Pty Ltd | 72724 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| ROBITUSSIN DRY COUGH FORTE dextromethorphan hydrobromide monohydrate 3 mg/mL oral liquid bottle | Haleon Australia Pty Ltd | 66734 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| LAMISIL DERMGEL terbinafine 10 mg/g tube | Haleon Australia Pty Ltd | 63434 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| DONNATAB tablet blister pack | Haleon Australia Pty Ltd | 60604 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| LAMISIL SPRAY terbinafine hydrochloride 10 mg/g spray solution aerosol pump actuated | Haleon Australia Pty Ltd | 59716 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| VOLTAREN EMULGEL diclofenac diethylamine 11.6 mg/g gel tube | Haleon Australia Pty Ltd | 47676 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| LAMISIL CREAM terbinafine hydrochloride 10mg/g tube | Haleon Australia Pty Ltd | 43524 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| VOLTAREN RAPID 25 diclofenac potassium 25 mg tablet blister pack | Haleon Australia Pty Ltd | 42942 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| ENO Lemon flavour powder | Haleon Australia Pty Ltd | 40656 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| ENO REGULAR oral powder jar | Haleon Australia Pty Ltd | 40655 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL SINUS RELIEF ORIGINAL FORMULA capsule-shaped tablet blister pack | Haleon Australia Pty Ltd | 35521 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL ALLERGY SINUS tablets blister pack | Haleon Australia Pty Ltd | 35520 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL RAPID SOLUBLE paracetamol 500 mg effervescent tablet strip pack | Haleon Australia Pty Ltd | 15509 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL CHILDREN 5 - 12 YEARS ELIXIR paracetamol 48 mg/mL oral liquid bottle | Haleon Australia Pty Ltd | 15506 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| ROBITUSSIN COUGH & CHEST CONGESTION oral liquid bottle | Haleon Australia Pty Ltd | 13884 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| Aquaear Ear Drops soution bottle | Haleon Australia Pty Ltd | 13857 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| PANADOL paracetamol 500mg Tablets - filmcoated blister pack | Haleon Australia Pty Ltd | 13591 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| AURALGAN EAR DROPS | Haleon Australia Pty Ltd | 10460 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| DE-GAS simethicone 100mg capsule blister pack | Haleon Australia Pty Ltd | 10395 | CON-1103 | The consent is effective from 4 May 2023 until 30 November 2025. | 4/05/2023 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the name and address of the previous sponsor. | import and supply | Over-the-counter medicines | ||
| TERRYWHITE CHEMMART DECONGESTANT NASAL SPRAY oxymetazoline hydrochloride 0.5 mg/mL spray solution bottle | Noumed Pharmaceuticals Pty Ltd | 308736 | CON-1100 | The consent is effective from 4 May 2023 until 30 June 2025. (the end of shelf-life for the affected batches). | 4/05/2023 | subsection 10(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The above batches of the products do not comply because the labels on the containers do not include the name of the antimicrobial preservative in the medicine. | import and supply | Over-the-counter medicines | ||
| PHARMACY CHOICE DECONGESTANT NASAL SPRAY oxymetazoline hydrochloride 0.5mg/mL solution bottle | Noumed Pharmaceuticals Pty Ltd | 58493 | 224472, 224473 | CON-1100 | The consent is effective from 4 May 2023 until 30 June 2025. (the end of shelf-life for the affected batches). | 4/05/2023 | subsection 10(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The above batches of the products do not comply because the labels on the containers do not include the name of the antimicrobial preservative in the medicine. | import and supply | Over-the-counter medicines | |
| SHI DU QING | Shen Neng Herbal Medicines Group Pty Ltd | 75334 | CON-1099 | The consent is effective from 2 May 2023 until 2 May 2024. | 2/05/2023 | section 6 of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products label incorrectly lists the spelling of the Approved Herbal Name (AHN) of the ingredient “Dictamnus dasycarpus” as “Dictamnus desycarpus”. | 1. All future cartons and labels of the affected product/s contain the correct spelling of the Approved Herbal Name (AHN) of the Ingredient ''Dictamnus dasycarpus". | import and supply | Over-the-counter medicines | |
| XERMELO telotristat ethyl (as telotristat etiprate) 250 mg film-coated tablet blister pack | Clinect Pty Ltd | 291734 | U22566 | CON-1098 | The consent is effective from 28 April 2023 until 30 November 2025 | 28/04/2023 | Paragraph 7(2)(b), Paragraph 8(1)(o), Section 8(2), Subparagraph 10(14)(a)(iv), Subparagraph 10(14)(a)(v) Subparagraph 10(14)(a)(ix), of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) include information that is required to be on the label in a language other than English, the correct name of the medicine is not on at least three non-opposing sides of the carton, the label of the medicine does not include a minimum space of 70 x 30 mm for the dispensing label, and the blister pack for the product does not include the name of the medicine, the name of all active ingredients in the medicine or the details of the sponsor or distributor of the medicine | A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 27 April 2023 will be supplied with the affected batch describing the label changes and providing an assurance there is no change to the medicine. | import and supply | Prescription medicines |
| VITRAKVI larotrectinib (as sulfate) 20 mg/mL bottle | Bayer Australia Ltd | 388084 | CON-1097 | The consent is effective from 21 April 2023 until 30 April 2025. | 21/04/2023 | Paragraph 8(1)(o) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product does not have the name of the medicine printed on the top or bottom panel, meaning it is not on three opposing sides | import and supply | Prescription medicines | ||
| COMIRNATY (tozinameran) COVID-19 VACCINE 10 micrograms/0.2 mL concentrated suspension for injection vial | Pfizer Australia Pty Ltd | 377111 | CON-1096 | The consent is effective from 19 April 2023 until 3 December 2023. | 19/04/2023 | multiple sections of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | -The product must be supplied with the alternative carton labels that were considered and agreed to as part of the evaluation under section 9D(3) of the Therapeutic Goods Act 1989 - a Dear Healthcare Professional Letter will be distributed with the product providing information to the prescribers of different presentations of the vaccine available, including how to differentiate them and what each is for. | import and supply | Prescription medicines | ||
| Cellular Therapies - T Cells - Brexucabtagene autoleucel, cryopreserved - T - Tecartus - Gilead Sciences Pty Ltd - Injection, intravenous infusion - Bag | Gilead Sciences Pty Ltd | 396794 | CON-1095 | The consent is effective from 13 April 2023 until 30 June 2023. | 13/04/2023 | Schedule 2, Part 1, Item 6 of Therapeutic Goods (Standard for Biologicals - Labelling Requirements) (TGO 107) Order 2021 | The products do not conform with Schedule 2, Part 1, Item 6 of TGO 107 that specifies that the name of the sponsor of the biological must be on the product label attached to the container. | import and supply | Blood, tissues, and biologicals | ||
| ABRAXANE nanoparticle albumin-bound paclitaxel 100 mg powder for injection (suspension) vial | Abraxis Bioscience Australia Pty Ltd | 133500 | 3A118B | CON-1094 | The consent is effective from 3 April 2023 until the affected batch is depleted. | 3/04/2023 | Paragraphs 8(1)(f) and 8(1)(g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product does not comply as the batch number and expiry date are not preceded by the correct prefix on the vial label, as the batch number is preceded by the date prefix and the date is preceded by the batch prefix. | A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 3 April 2023 will be supplied with each affected batch warning that the batch number and expiry date are not preceded by the correct prefix on the vial label, and therefore the vial must be stored in the carton when not in use. | import and supply | Prescription medicines |
| CODALGIN FORTE codeine phosphate hemihydrate 30 mg and paracetamol 500 mg tablet blister pack | Viatris Pty Ltd | 226337 | CON-1093 | The consent is effective from 31 March 2023 until 31 March 2024. | 31/03/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The name and address of the current sponsor or supplier of the goods is not included on the label. | 1.The labels to which this consent applies are those previously approved in submission. The requirements are to maintain the redirection from the old website (www.mylan.com.au ) to the new website (www.viatris.com.au) until the expiry of the last batch released under this consent. 2.Batches released after the expiry of this exemption will be required to be over-stickered if they still contain the incorrect name and contact details of the sponsor or supplier of the product. | supply | Prescription medicines | |
| MAXAMOX amoxicillin trihydrate 500 mg/5 mLpowder for oral suspension bottle | Sandoz Pty Ltd | 93722 | CON-1091 | The consent is effective from 21 March 2023 until 21 March 2025. | 21/03/2023 | Paragraph 8(1)(b) and Paragraph 8(1)(c) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The expression of the active ingredient name is non compliant. The expression of the quantity/proportion of the active ingredient is non compliant. | import and supply | Prescription medicines | ||
| CURAM DUO 500/125 amoxicillin 500 mg (as trihydrate) & clavulanic acid 125 mg (as potassium) tablet strip pack | Sandoz Pty Ltd | 82830 | CON-1091 | The consent is effective from 21 March 2023 until 21 March 2025. | 21/03/2023 | Paragraph 8(1)(b) and Paragraph 8(1)(c) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The expression of the active ingredient name is non compliant. The expression of the quantity/proportion of the active ingredient is non compliant. | 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-1091 | The consent is effective from 21 March 2023 until 21 March 2025. | 21/03/2023 | Paragraph 8(1)(b) and Paragraph 8(1)(c) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The expression of the active ingredient name is non compliant. The expression of the quantity/proportion of the active ingredient is non compliant. | import and supply | Prescription medicines | ||
| CURAM DUO 400/57 amoxicillin 400 mg/5 mL (as trihydrate) / clavulanic acid 57 mg/5 mL (as potassium clavulanate) powder for suspension bottle | Sandoz Pty Ltd | 147109 | CON-1091 | The consent is effective from 21 March 2023 until 21 March 2025. | 21/03/2023 | Paragraph 8(1)(b) and Paragraph 8(1)(c) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The expression of the active ingredient name is non compliant. The expression of the quantity/proportion of the active ingredient is non compliant. | import and supply | Prescription medicines | ||
| CURAM 125/31.25 amoxicillin (as trihydrate) 125 mg/5 mL clavulanic acid (as potassium clavulanate) 31.25 mg/5 mL powder for suspension bottle | Sandoz Pty Ltd | 146979 | CON-1091 | The consent is effective from 21 March 2023 until 21 March 2025. | 21/03/2023 | Paragraph 8(1)(b) and Paragraph 8(1)(c) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The expression of the active ingredient name is non compliant. The expression of the quantity/proportion of the active ingredient is non compliant. | import and supply | Prescription medicines | ||
| AMOXYCILLIN SANDOZ amoxicillin trihydrate 250 mg/5 mL powder for oral suspension bottle | Sandoz Pty Ltd | 93720 | CON-1091 | The consent is effective from 21 March 2023 until 21 March 2025. | 21/03/2023 | Paragraph 8(1)(b) and Paragraph 8(1)(c) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The expression of the active ingredient name is non compliant. The expression of the quantity/proportion of the active ingredient is non compliant. | import and supply | Prescription medicines | ||
| CURAM DUO 500/125 amoxicillin 500 mg (as trihydrate) & clavulanic acid 125 mg (as potassium) tablet strip pack | Sandoz Pty Ltd | 82830 | CON-1089 | The consent is effective from 21 March 2023 until 21 March 2025. | 21/03/2023 | Paragraph 8(1)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The expression of trade name is non compliant. | 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-1089 | The consent is effective from 21 March 2023 until 21 March 2025. | 21/03/2023 | Paragraph 8(1)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The expression of trade name is non compliant. | import and supply | Prescription medicines | ||
| CURAM DUO 400/57 amoxicillin 400 mg/5 mL (as trihydrate) / clavulanic acid 57 mg/5 mL (as potassium clavulanate) powder for suspension bottle | Sandoz Pty Ltd | 147109 | CON-1089 | The consent is effective from 21 March 2023 until 21 March 2025. | 21/03/2023 | Paragraph 8(1)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The expression of trade name is non compliant. | import and supply | Prescription medicines | ||
| CURAM 125/31.25 amoxicillin (as trihydrate) 125 mg/5 mL clavulanic acid (as potassium clavulanate) 31.25 mg/5 mL powder for suspension bottle | Sandoz Pty Ltd | 146979 | CON-1089 | The consent is effective from 21 March 2023 until 21 March 2025. | 21/03/2023 | Paragraph 8(1)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The expression of trade name is non compliant. | import and supply | Prescription medicines | ||
| PHYSEPTONE LIQUID methadone hydrochloride 5 mg/mL oral liquid bottle | Aspen Pharma Pty Ltd | 381325 | CON-1088 | The consent is effective from 20 March 2023 until 17 March 2025. | 20/03/2023 | USP Methadone Hydrochloride Oral Solution monograph: pH range. of United States Pharmacopoeia | The products do not meet the pH requirements specified in the Methadone Hydrochloride Oral Solution monograph (United States Pharmacopoeia 2023) which requires a pH range of 1.0 - 4.0. | supply | Prescription medicines | ||
| OPOD-P LIQUID methadone hydrochloride 5 mg/mL oral liquid bottle | Aspen Pharma Pty Ltd | 380871 | CON-1088 | The consent is effective from 20 March 2023 until 17 March 2025. | 20/03/2023 | USP Methadone Hydrochloride Oral Solution monograph: pH range. of United States Pharmacopoeia | The products do not meet the pH requirements specified in the Methadone Hydrochloride Oral Solution monograph (United States Pharmacopoeia 2023) which requires a pH range of 1.0 - 4.0. | supply | Prescription medicines | ||
| BONDRONAT ibandronic acid 50 mg film-coated tablet blister pack | Atnahs Pharma Australia Pty | 119673 | P0005B08W01, P0025B01W02, P0025B01W03 and P0025B01W04 | CON-1085 | The consent is effective from 20 March 2023 until the stated batch/es are exhausted or 30 November 2024. | 20/03/2023 | paragraphs 8(1)(f) and 8(1)(g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product label does not have the batch number and expiry date prefixes included in the debossing of the blister foil. | import and supply | Prescription medicines | |
| PRILOTEKAL prilocaine hydrochloride 100 mg/5 mL solution for injection ampoule | B Braun Australia Pty Ltd | 376271 | All relevant batches of the product released from the 16 March 2023 until 16 March 2028 | CON-1114 | The consent is effective from 16 March 2023 until 16 March 2028. | 16/03/2023 | The product does not conform with the requirements of official standards, either Prilocaine Injection (British Pharmacopoeia 2023) or Prilocaine Hydrochloride Injection (United States Pharmacopeia 2023). of United States Pharmacopoeia | The product does not necessarily conform because: • It has a pH in the range 4.0 – 6.0. • The Prilocaine Injection (British Pharmacopoeia 2023) monograph requires Acidity: pH 5.0 to 7.0; • The Prilocaine Hydrochloride Injection (United States Pharmacopeia 2023) monograph requires pH 〈791〉: 6.0–7.0. | The pH of the injection is in the range 4.0 – 6.0. | import and supply | Prescription medicines |
| blood components including red cells, platelets, plasma for transfusion and plasma for fractionation as defined in the Lifeblood TMF | Australian Red Cross Lifeblood | CON-1090 | The consent is effective from 16 March 2023 until 1 October 2031 | 16/03/2023 | Part 2 Section 10 (9) Schedule 1 Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products will not comply with the requirement of indefinite deferral for variant Creutzfeldt-Jakob disease (vCJD) risk, applicable to blood and plasma donors having received a transfusion or injection of blood or blood components while in England, Scotland, Wales, Northern Ireland or the Isle of Man at any time on or after the 1 January 1980. | 1. Lifeblood continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. 2. Lifeblood does not implement the change for plasma for fractionation until CSL Behring have submitted a variation to TGA for the change and subsequently received approval from TGA for the change. | supply | Blood, tissues, and biologicals | ||
| blood components including red cells, platelets, plasma for transfusion and plasma for fractionation as defined in the Lifeblood TMF | Australian Red Cross Lifeblood | CON-1087 | The consent is effective from 16 March 2023 until 1 April 2029. | 16/03/2023 | Section 7(4)(b) of Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019 | The products will not comply with the requirement of indefinite deferral for variant Creutzfeldt-Jakob disease (vCJD) risk, applicable to blood and plasma donors having received a transfusion or injection of blood or blood components while in England, Scotland, Wales, Northern Ireland or the Isle of Man at any time on or after the 1 January 1980. | 1. Lifeblood continues to monitor the literature and informs the TGA of any new evidence that substantively alters the estimated risks, such that they become unacceptable. 2. Lifeblood does not implement the change for plasma for fractionation until CSL Behring have submitted a variation to TGA for the change and subsequently received approval from TGA for the change. | supply | Blood, tissues, and biologicals | ||
| ALIMTA pemetrexed (as disodium) 500 mg powder for injection vial | Eli Lilly Australia Pty Ltd | 96731 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| CIALIS tadalafil 10 mg tablet blister pack | Eli Lilly Australia Pty Ltd | 90590 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| CIALIS tadalafil 20 mg tablet blister pack | Eli Lilly Australia Pty Ltd | 81137 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| ZYPREXA IM olanzapine 10 mg powder for injection vial | Eli Lilly Australia Pty Ltd | 76867 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| HUMALOG MIX50 insulin lispro 100 IU/mL injection multidose cartridge | Eli Lilly Australia Pty Ltd | 69166 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| HUMALOG MIX25 insulin lispro 100 IU/mL injection multidose cartridge | Eli Lilly Australia Pty Ltd | 69163 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| EVISTA raloxifene hydrochloride 60 mg tablet blister pack | Eli Lilly Australia Pty Ltd | 64709 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| HUMALOG insulin lispro 100 IU/mL injection multidose cartridge | Eli Lilly Australia Pty Ltd | 53466 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| HUMATROPE somatropin 18IU (6 mg) powder for injection cartridge with diluent syringe | Eli Lilly Australia Pty Ltd | 53423 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| HUMATROPE somatropin 36IU (12 mg) powder for injection cartridge with diluent syringe | Eli Lilly Australia Pty Ltd | 53365 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| HUMATROPE somatropin 72IU (24 mg) powder for injection cartridge with diluent syringe | Eli Lilly Australia Pty Ltd | 53364 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| HUMULIN R biosynthetic human neutral insulin 100IU/mL injection multidose cartridge | Eli Lilly Australia Pty Ltd | 39666 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| HUMULIN NPH biosynthetic human isophane insulin 100IU/mL injection multidose cartridge | Eli Lilly Australia Pty Ltd | 39662 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| HUMULIN 30/70 biosynthetic human 30% neutral 70% isophane insulin 100IU/mL injection multidose cartridge | Eli Lilly Australia Pty Ltd | 39659 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| OLUMIANT baricitinib 4 mg film-coated tablet blister pack | Eli Lilly Australia Pty Ltd | 277917 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| OLUMIANT baricitinib 2 mg film-coated tablet blister pack | Eli Lilly Australia Pty Ltd | 277905 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| ALIMTA pemetrexed (as disodium) 100 mg powder for injection vial | Eli Lilly Australia Pty Ltd | 146828 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| ZYPREXA RELPREVV olanzapine (as pamoate monohydrate) 210 mg powder for injection vial with diluent vial | Eli Lilly Australia Pty Ltd | 143658 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| ZYPREXA RELPREVV olanzapine (as pamoate monohydrate) 300 mg powder for injection vial with diluent vial | Eli Lilly Australia Pty Ltd | 143657 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| ZYPREXA RELPREVV olanzapine (as pamoate monohydrate) 405 mg powder for injection vial with diluent vial | Eli Lilly Australia Pty Ltd | 143636 | CON-1084 | The consent is effective from 16 March 2023 until 30 September 2026. | 16/03/2023 | Paragraphs 8(1)(f) and (g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not comply as the product labels do not have the batch and expiry prefixes immediately preceding the batch and expiry variable data on the carton and/or container labels. | import, supply, and export | Prescription medicines | ||
| PRILOTEKAL prilocaine hydrochloride 100 mg/5 mL solution for injection ampoule | B Braun Australia Pty Ltd | 376271 | CON-1083 | The consent is effective from 16 March 2023 until 16 March 2028. | 16/03/2023 | pH requirements of Prilocaine Injection (British Pharmacopoeia 2023) or Prilocaine Hydrochloride Injection (United States Pharmacopeia 2023). of British Pharmacopoeia | The product does not necessarily conform because: • It has a pH in the range 4.0 – 6.0. • The Prilocaine Injection (British Pharmacopoeia 2023) monograph requires Acidity: pH 5.0 to 7.0; • The Prilocaine Hydrochloride Injection (United States Pharmacopeia 2023) monograph requires pH 〈791〉: 6.0–7.0. | Import and supply | Prescription medicines | ||
| PRIORIX ALBUMIN FREE VACCINE 0.5 mL powder for injection vial and diluent syringe | GlaxoSmithKline Australia Pty Ltd | 97842 | CON-1086 | The consent is effective from 9 March 2023 until 1 October 2026 | 9/03/2023 | Section 6 and Subsection 10(3) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | the excipient names on the labels do not align with the AAN and the quantity of all excipients is not specified on the label as detailed below: Names of all fifteen ingredients and their quantity should be included on the label. | Non-compliance is limited to TGO 91 requirements only. | import and supply | Prescription medicines | |
| PRIORIX-TETRA vaccine 0.5 mL powder for injection vial with diluent syringe | GlaxoSmithKline Australia Pty Ltd | 107286 | CON-1082 | The consent is effective from 9 March 2023 until 1 October 2026. | 9/03/2023 | Section 6 and paragraph 10(3)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The excipient names on the labels do not align with the Australian Approved Names and the quantity of all excipients is not specified on the label. | import and supply | Prescription medicines | ||
| FERRO-F-TAB film coated tablets blister pack - Ferrous Fumarate (310 mg) and Folic Acid (350 mg) | AFT Pharmaceuticals Pty Ltd | 128099 | 7847 | CON-1081 | The consent is effective from 8 March 2023 until 18 December 2024. | 8/03/2023 | of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The batch (07847) does not comply with approved indication for the product with the indication (Uses) printed on the cartons of the affected batch as the carton states: "Source of iron and folic acid for the prevention and treatment of iron and folic acid deficiency anaemias, including in pregnancy". Instead of the approved indication: “Source of iron and folic acid for the prevention and treatment of iron and folic acid deficiency anaemia, including in pregnancy” | import and supply | Registered complementary medicines | |
| SCHOLL CORN WASHPROOF REMOVAL PLASTERS salicylic acid 400 mg/g dressing - medicated sachet | Scholls Wellness Company Pty Ltd | 46407 | CON-1080 | The consent is effective from 6 March 2023 until 5 December 2023. | 6/03/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product does not comply because the label displays the contact details for the previous sponsor (Reckitt Benckiser Pty Ltd) instead of the contact details for the new sponsor (Scholls Wellness Company Pty Ltd). | supply | Over-the-counter medicines | ||
| GASTROGEL ANTACID oral liquid bottle | Viatris Pty Ltd | 13452 | DP126 | CON-1079 | The consent is effective from 6 March 2023 until Batch DP126 has depleted | 6/03/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The label does not display the name of the current sponsor. | supply | Over-the-counter medicines | |
| SOLUPREP ANTISEPTIC SWAB large (clear) medicated swab | 3M Australia Pty Ltd | 226788 | CON-1074 | The consent is effective from 6 March 2023 until 1 October 2024. | 6/03/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The labels do not include certain required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (RASML No. 6). Specifically, the labels do not include the statement “Seek immediate medical assistance if this occurs” and instead state “Stop use if this occurs”. They also do not include the specific statement “Mild skin irritation may occur; stop use if it becomes more severe.” but instead state “Discontinue use if irritation and redness develops”. | supply | Over-the-counter medicines | ||
| IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial | Biocelect Pty Ltd (On behalf of Substipharm) | 162215 | CON-1076 | The consent is effective from 3 March 2023 until 3 March 2024. | 3/03/2023 | Section 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The name and contact details of the current Sponsor or distributor of the medicine is not included on the carton and vial label, and the product information leaflet. | 1. The product must be supplied with the labels that were submitted with the s.14 application on 21 February 2023; as follows: a) Carton label b) Powder for injection vial c) Diluent vial 2. Arrangements must be in place for the prompt referral of any queries or complaints concerning the product to the current Sponsor Biocelect Pty Ltd. 3. Non-compliance with the Therapeutic Goods Order 91 Standard for labels of prescription and related medicines is limited to this information. | import and supply | Prescription medicines | |
| SOLUPREP ANTISEPTIC SWAB LARGE (tinted) medicated swab sachet | 3M Australia Pty Ltd | 226781 | CON-1075 | The consent is effective from 3 March 2023 until 1 August 2023. | 3/03/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The labels do not include certain required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (RASML No. 6). Specifically, the labels do not include the statement “Seek immediate medical assistance if this occurs” and instead state “Stop use if this occurs”. They also do not include the specific statement “Mild skin irritation may occur; stop use if it becomes more severe.” but instead state “Discontinue use if irritation and redness develops”. | supply | Over-the-counter medicines | ||
| SOLUPREP ANTISEPTIC WIPE LARGE (1.5ml) medicated wipe sachet | 3M Australia Pty Ltd | 226786 | CON-1073 | The consent is effective from 3 March 2023 until 1 October 2023. | 3/03/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The labels do not include certain required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (RASML No. 6). Specifically, the labels do not include the statement “Seek immediate medical assistance if this occurs” and instead state “Stop use if this occurs”. They also do not include the specific statement “Mild skin irritation may occur; stop use if it becomes more severe.” but instead state “Discontinue use if irritation and redness develops”. | supply | Over-the-counter medicines | ||
| SOLUPREP ANTISEPTIC SPONGE (tinted) sponge blister pack | 3M Australia Pty Ltd | 226782 | CON-1072 | The consent is effective from 3 March 2023 until 1 January 2024. | 3/03/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The labels do not include certain required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (RASML No. 6). Specifically, the labels do not include the statement “Seek immediate medical assistance if this occurs” and instead state “Stop use if this occurs”. They also do not include the specific statement “Mild skin irritation may occur; stop use if it becomes more severe.” but instead state “Discontinue use if irritation and redness develops”. | supply | Over-the-counter medicines | ||
| SOLUPREP ANTISEPTIC SWAB SMALL (clear) medicated swab sachet | 3M Australia Pty Ltd | 226779 | CON-1072 | The consent is effective from 3 March 2023 until 1 January 2024. | 3/03/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The labels do not include certain required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (RASML No. 6). Specifically, the labels do not include the statement “Seek immediate medical assistance if this occurs” and instead state “Stop use if this occurs”. They also do not include the specific statement “Mild skin irritation may occur; stop use if it becomes more severe.” but instead state “Discontinue use if irritation and redness develops”. | supply | Over-the-counter medicines | ||
| SOLUPREP ANTISEPTIC WIPE SMALL medicated wipe sachet | 3M Australia Pty Ltd | 226778 | CON-1071 | The consent is effective from 3 March 2023 until 1 June 2025. | 3/03/2023 | paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The labels do not include certain required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (RASML No. 6). Specifically, the labels do not include the statement “Seek immediate medical assistance if this occurs” and instead state “Stop use if this occurs”. They also do not include the specific statement “Mild skin irritation may occur; stop use if it becomes more severe.” but instead state “Discontinue use if irritation and redness develops”. | supply | Over-the-counter medicines | ||
| SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial | Adjutor Healthcare Pty Ltd (on behalf of Moderna Australia Pty Ltd) | 389513 | CON-1077 | The consent is effective from 1 March 2023 until 29 August 2024. | 1/03/2023 | of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | 1. The product must be supplied with the labels that were considered and agreed to as part of the evaluation under section 9D(3) of the Therapeutic Goods Act 1989, being the ‘International Labels’, suspension for injection vial and carton labels, for the drug product referred to in submission. as follows: a) SPIKEVAX BIVALENT ORIGINAL/OMICRON 2.5 mL Carton Samsung 5501801 b) SPIKEVAX BIVALENT ORIGINAL/OMICRON 2.5 mL Label Samsung 5501701 c) SPIKEVAX BIVALENT ORIGINAL/OMICRON 2.5 mL Label Samsung 30001 | import and supply | Prescription medicines | ||
| COMIRNATY ORIGINAL/OMICRON BA.4-5 (tozinameran/famtozinameran) COVID-19 VACCINE 15/15 micrograms/0.3 mL suspension for injection vial | Pfizer Australia Pty Ltd | 400874 | CON-1078 | The consent is effective from 27 February 2023 until 20 January 2025. | 27/02/2023 | of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product will be supplied with International labels. | The product must be supplied with the labels that were considered and agreed to as part of the evaluation under section 9D(3) of the Therapeutic Goods Act 1989, being the ‘International Labels’ evaluated in submission. | import and supply | Prescription medicines | |
| COMIRNATY ORIGINAL/OMICRON BA.4-5 (tozinameran/famtozinameran) COVID-19 VACCINE 15/15 micrograms/0.3 mL suspension for injection vial | Pfizer Australia Pty Ltd | 400874 | CON-1070 | The consent is effective from 27 February 2023 until 20 January 2025. | 27/02/2023 | of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The carton labels of the product does not conform to TGO 91. | a. The product must be supplied with the carton labels (10 multidose vials) that were considered and agreed to as part of the evaluation under section 9D(3) of the Therapeutic Goods Act 1989, being the ‘International Labels’ submitted with the application on 23 February 2023. | import and supply | Prescription medicines | |
| Musculoskeletal Tissue - Victorian Institute of Forensic Medicine T/A Donor Tissue Bank of Victoria | The Victorian Institute of Forensic Medicine T/A Donor Tissue Bank of Victoria | 238244 | The consent is limited to the 237 non-compliant allografts specified in the submission dated 20 February 2023. | CON-1068 | The consent is effective from 23 February 2023 until 23 February 2027. | 23/02/2023 | clause 24(a)(ii) of TGO 109 of Therapeutic Goods (Standards for Biologicals-General and Specific Requirements) (TGO 109) Order 2021 | The biologicals were not stored at the required storage temperature for approximately 3.5 hours. | The consent is limited to the 237 non-compliant allografts specified in the submission dated 20 February 2023. | supply | Blood, tissues, and biologicals |
| SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial | Adjutor Healthcare Pty Ltd (on behalf of Moderna Australia Pty Ltd) | 389513 | CON-1069 | The consent is effective from 22 February 2023 until 29 August 2024. | 22/02/2023 | of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products are supplied with International Labels | The product must be supplied with the labels that were considered and agreed to as part of the evaluation under section 9D(3) of the Therapeutic Goods Act 1989, being the ‘International Labels’, suspension for injection vial and carton labels, for the drug product referred to in submission. | import and supply | Prescription medicines | |
| Sun Zapper Ultra Clear Zinc Sunscreen SPF50+ | Sun Zapper Sun Care Pty Ltd | 345771 | CON-1067 | The consent is effective from 8 February 2023 until 31 March 2023. | 8/02/2023 | Ph. Eur. Monograph 2584 of European Pharmacopoeia | The product doesn’t comply with the test limits for Hydroxyl value and Acid Value in the applicable monograph. | Accelerated and real time stability testing will continue on the impacted batches and any out of specification results observed during this stability testing will be reported to the TGA. | supply | Listed complementary medicines | |
| Baby & Child Teething Gel | Brauer Natural Medicine Pty Ltd | 347981 | CON-1066 | The consent is effective from 7 February 2023 until 1 October 2026. | 7/02/2023 | subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | supply | Listed complementary medicines | |||
| Baby & Child Teething | Brauer Natural Medicine Pty Ltd | 351865 | CON-1066 | The consent is effective from 7 February 2023 until 1 October 2026. | 7/02/2023 | subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | supply | Listed complementary medicines | |||
| Baby & Child Stomach Calm | Brauer Natural Medicine Pty Ltd | 323471 | CON-1066 | The consent is effective from 7 February 2023 until 1 October 2026. | 7/02/2023 | subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | supply | Listed complementary medicines | |||
| Baby & Child Sleep | Brauer Natural Medicine Pty Ltd | 322409 | CON-1066 | The consent is effective from 7 February 2023 until 1 October 2026. | 7/02/2023 | subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | supply | Listed complementary medicines | |||
| Baby & Child Runny Nose | Brauer Natural Medicine Pty Ltd | 322616 | CON-1066 | The consent is effective from 7 February 2023 until 1 October 2026. | 7/02/2023 | subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | supply | Listed complementary medicines | |||
| Baby & Child Immunity Support | Brauer Natural Medicine Pty Ltd | 322578 | CON-1066 | The consent is effective from 7 February 2023 until 1 October 2026. | 7/02/2023 | subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | supply | Listed complementary medicines | |||
| Baby & Child Cough | Brauer Natural Medicine Pty Ltd | 383114 | CON-1066 | The consent is effective from 7 February 2023 until 1 October 2026. | 7/02/2023 | subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | supply | Listed complementary medicines | |||
| Baby & Child Colic | Brauer Natural Medicine Pty Ltd | 322575 | CON-1066 | The consent is effective from 7 February 2023 until 1 October 2026. | 7/02/2023 | subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | supply | Listed complementary medicines | |||
| Baby & Child Cold & Flu | Brauer Natural Medicine Pty Ltd | 322577 | CON-1066 | The consent is effective from 7 February 2023 until 1 October 2026. | 7/02/2023 | subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | supply | Listed complementary medicines | |||
| Baby & Child Calm | Brauer Natural Medicine Pty Ltd | 322579 | CON-1066 | The consent is effective from 7 February 2023 until 1 October 2026. | 7/02/2023 | subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | supply | Listed complementary medicines | |||
| Musculoskeletal Tissue - Victorian Institute of Forensic Medicine T/A Donor Tissue Bank of Victoria | The Victorian Institute of Forensic Medicine T/A Donor Tissue Bank of Victoria | 238244 | CBM-T00020-20-25, CBM-T00020-20-26, CBM-T00020-20-27, CBM-T00020-20-28, CBM-T00020-20-29, CBM-T00020-20-30, CBM-T00020-20-31, CBM-T00020-20-32, CBM-T00020-20-33, CBM-T00020-20-34, CBM-T00020-20-35, CBM-T00020-20-36, CBM-T00020-20-37, CBM-T00020-20-38, CBM-T00020-20-39, CBM-T00020-20-40, CBM-T00020-20-41, CBM-T00020-20-42, CBM-T00020-20-43, CBM-T00020-20-44, CBM-T00020-20-45, CBM-T00020-20-46, CBM-T00020-20-47, CBM-T00020-20-48, CBM-T00020-20-49, CBM-T00020-20-50, CBM-T00020-20-51, CBM-T00020-20-52, CBM-T00020-20-53, CBM-T00020-20-54 | CON-1065 | The consent is effective from 1 February 2023 until 1 February 2024. | 1/02/2023 | Schedule 2, Part 2, Item 9 of Therapeutic Goods (Standard for Biologicals - Labelling Requirements) (TGO 107) Order 2021 | The incorrect expiry date of the biological has been printed on the product labels. | import and supply | Blood, tissues, and biologicals | |
| VOXZOGO vosoritide 1.2 mg powder for injection vial and diluent pre-filled syringe | BioMarin Pharmaceutical Australia Pty Ltd | 376618 | CON-1107 | The consent is effective from 16 January 2023 until 31 July 2023. The consent is effective for all batches of the product that are labelled as per the international English/ bilingual language pack for marketing in the EU (as described in the consent letter) imported into and supplied in Australia. | 16/01/2023 | Carton section 8(1)(h), section 8(1)(d), section 8(1)(l), section 8(1)(l)(iii), section 9(3)(a), section 10(3)(a), section 10(3)(b) Vial label section 10(5)(d), section 10(5)(h) Intermediate packaging label (diluent syringe tray) section 8(3)(a), section 8(3)(c), section 8(3)(f) Diluent syringe label section 10(5)(d) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products are labelled as per the international English / bilingual language pack for marketing in the EU. | 1. The consent only applies to affected batches (international English/ bilingual language pack for marketing in the EU) imported into and supplied in Australia on or before 31st July 2023. 2. The Sponsor will advise pharmacies and affected healthcare providers of the temporary use of international labels, including links to the Australian Product Information (PI) and Consumer Medicine Information (CMI). 3. The Sponsor will over-sticker the carton label to include: a. the Australian Sponsor’s details on the main label prefaced by “Supplied by:” to make it clear to consumers it is the Australian distributor. b. the AUST R number. c. signal heading 'PRESCRIPTION ONLY MEDICINE' and cautionary statement 'KEEP OUT OF REACH OF CHILDREN'. d. the statement “Refer to the Australian CMI available at www.biomarin.com/en-au/voxzogoconsumer-medicine-information/” on the main label to allow patients and their carers easy access to the Australian approved CMI which also includes Instructions for use. | import and supply | Prescription medicines | |
| VOXZOGO vosoritide 0.56 mg powder for injection vial and diluent pre-filled syringe | BioMarin Pharmaceutical Australia Pty Ltd | 376617 | CON-1107 | The consent is effective from 16 January 2023 until 31 July 2023. The consent is effective for all batches of the product that are labelled as per the international English/ bilingual language pack for marketing in the EU (as described in the consent letter) imported into and supplied in Australia. | 16/01/2023 | Carton section 8(1)(h), section 8(1)(d), section 8(1)(l), section 8(1)(l)(iii), section 9(3)(a), section 10(3)(a), section 10(3)(b) Vial label section 10(5)(d), section 10(5)(h) Intermediate packaging label (diluent syringe tray) section 8(3)(a), section 8(3)(c), section 8(3)(f) Diluent syringe label section 10(5)(d) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products are labelled as per the international English / bilingual language pack for marketing in the EU. | 1. The consent only applies to affected batches (international English/ bilingual language pack for marketing in the EU) imported into and supplied in Australia on or before 31st July 2023. 2. The Sponsor will advise pharmacies and affected healthcare providers of the temporary use of international labels, including links to the Australian Product Information (PI) and Consumer Medicine Information (CMI). 3. The Sponsor will over-sticker the carton label to include: a. the Australian Sponsor’s details on the main label prefaced by “Supplied by:” to make it clear to consumers it is the Australian distributor. b. the AUST R number. c. signal heading 'PRESCRIPTION ONLY MEDICINE' and cautionary statement 'KEEP OUT OF REACH OF CHILDREN'. d. the statement “Refer to the Australian CMI available at www.biomarin.com/en-au/voxzogoconsumer-medicine-information/” on the main label to allow patients and their carers easy access to the Australian approved CMI which also includes Instructions for use. | import and supply | Prescription medicines | |
| VOXZOGO vosoritide 0.4 mg powder for injection vial and diluent pre-filled syringe | BioMarin Pharmaceutical Australia Pty Ltd | 376616 | CON-1107 | The consent is effective from 16 January 2023 until 31 July 2023. The consent is effective for all batches of the product that are labelled as per the international English/ bilingual language pack for marketing in the EU (as described in the consent letter) imported into and supplied in Australia. | 16/01/2023 | Carton section 8(1)(h), section 8(1)(d), section 8(1)(l), section 8(1)(l)(iii), section 9(3)(a), section 10(3)(a), section 10(3)(b) Vial label section 10(5)(d), section 10(5)(h) Intermediate packaging label (diluent syringe tray) section 8(3)(a), section 8(3)(c), section 8(3)(f) Diluent syringe label section 10(5)(d) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products are labelled as per the international English / bilingual language pack for marketing in the EU. | 1. The consent only applies to affected batches (international English/ bilingual language pack for marketing in the EU) imported into and supplied in Australia on or before 31st July 2023. 2. The Sponsor will advise pharmacies and affected healthcare providers of the temporary use of international labels, including links to the Australian Product Information (PI) and Consumer Medicine Information (CMI). 3. The Sponsor will over-sticker the carton label to include: a. the Australian Sponsor’s details on the main label prefaced by “Supplied by:” to make it clear to consumers it is the Australian distributor. b. the AUST R number. c. signal heading 'PRESCRIPTION ONLY MEDICINE' and cautionary statement 'KEEP OUT OF REACH OF CHILDREN'. d. the statement “Refer to the Australian CMI available at www.biomarin.com/en-au/voxzogoconsumer-medicine-information/” on the main label to allow patients and their carers easy access to the Australian approved CMI which also includes Instructions for use. | import and supply | Prescription medicines | |
| VOXZOGO vosoritide 1.2 mg powder for injection vial and diluent pre-filled syringe | PharmaLex Pty Ltd (agent for BioMarin Pharmaceutical Australia Pty Ltd) | 376618 | CON-1063 | The consent is effective from 16 January 2023 until 31 July 2023. | 16/01/2023 | section 8(1)(h), section 11(5)(iii), section 8(1)(d), section 8(1)(l), section 8(1)(l)(iii), section 9(3)(a), section 10(3)(a), section 10(3)(b), section 10(5)(d), section 10(5)(h), section 8(3)(a), section 8(3)(c), section 8(3)(f) and section 10(5)(d) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products are labelled as per the international English / bilingual language pack for marketing in the EU. | 1. The consent only applies to affected batches (international English/ bilingual language pack for marketing in the EU) imported into and supplied in Australia on or before 31st July 2023. 2. The Sponsor will advise pharmacies and affected healthcare providers of the temporary use of international labels, including links to the Australian PI and CMI, as detailed in the section14 request. 3. The Sponsor will over-sticker the carton label to include: a. the Australian Sponsor’s details on the main label prefaced by “Supplied by:” to make it clear to consumers it is the Australian distributor. b. the AUST R number. c. signal heading 'PRESCRIPTION ONLY MEDICINE' and cautionary statement 'KEEP OUT OF REACH OF CHILDREN'. d. the statement “Refer to the Australian CMI available at www.biomarin.com/en-au/voxzogoconsumer-medicine-information/” on the main label to allow patients and their carers easy access to the Australian approved CMI which also includes Instructions For Use. | Import and supply | Prescription medicines | |
| VOXZOGO vosoritide 0.56 mg powder for injection vial and diluent pre-filled syringe | PharmaLex Pty Ltd (agent for BioMarin Pharmaceutical Australia Pty Ltd) | 376617 | CON-1063 | The consent is effective from 16 January 2023 until 31 July 2023. | 16/01/2023 | section 8(1)(h), section 11(5)(iii), section 8(1)(d), section 8(1)(l), section 8(1)(l)(iii), section 9(3)(a), section 10(3)(a), section 10(3)(b), section 10(5)(d), section 10(5)(h), section 8(3)(a), section 8(3)(c), section 8(3)(f) and section 10(5)(d) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products are labelled as per the international English / bilingual language pack for marketing in the EU. | 1. The consent only applies to affected batches (international English/ bilingual language pack for marketing in the EU) imported into and supplied in Australia on or before 31st July 2023. 2. The Sponsor will advise pharmacies and affected healthcare providers of the temporary use of international labels, including links to the Australian PI and CMI, as detailed in the section14 request. 3. The Sponsor will over-sticker the carton label to include: a. the Australian Sponsor’s details on the main label prefaced by “Supplied by:” to make it clear to consumers it is the Australian distributor. b. the AUST R number. c. signal heading 'PRESCRIPTION ONLY MEDICINE' and cautionary statement 'KEEP OUT OF REACH OF CHILDREN'. d. the statement “Refer to the Australian CMI available at www.biomarin.com/en-au/voxzogoconsumer-medicine-information/” on the main label to allow patients and their carers easy access to the Australian approved CMI which also includes Instructions For Use. | Import and supply | Prescription medicines | |
| VOXZOGO vosoritide 0.4 mg powder for injection vial and diluent pre-filled syringe | PharmaLex Pty Ltd (agent for BioMarin Pharmaceutical Australia Pty Ltd) | 376616 | CON-1063 | The consent is effective from 16 January 2023 until 31 July 2023. | 16/01/2023 | section 8(1)(h), section 11(5)(iii), section 8(1)(d), section 8(1)(l), section 8(1)(l)(iii), section 9(3)(a), section 10(3)(a), section 10(3)(b), section 10(5)(d), section 10(5)(h), section 8(3)(a), section 8(3)(c), section 8(3)(f) and section 10(5)(d) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products are labelled as per the international English / bilingual language pack for marketing in the EU. | 1. The consent only applies to affected batches (international English/ bilingual language pack for marketing in the EU) imported into and supplied in Australia on or before 31st July 2023. 2. The Sponsor will advise pharmacies and affected healthcare providers of the temporary use of international labels, including links to the Australian PI and CMI, as detailed in the section14 request. 3. The Sponsor will over-sticker the carton label to include: a. the Australian Sponsor’s details on the main label prefaced by “Supplied by:” to make it clear to consumers it is the Australian distributor. b. the AUST R number. c. signal heading 'PRESCRIPTION ONLY MEDICINE' and cautionary statement 'KEEP OUT OF REACH OF CHILDREN'. d. the statement “Refer to the Australian CMI available at www.biomarin.com/en-au/voxzogoconsumer-medicine-information/” on the main label to allow patients and their carers easy access to the Australian approved CMI which also includes Instructions For Use. | Import and supply | Prescription medicines | |
| DEXAMETHASONE VIATRIS dexamethasone phosphate (as dexamethasone sodium phosphate) 8 mg/2 mL solution for injection vial | Alphapharm Pty Ltd | 163199 | CON-1064 | The consent is effective from 12 January 2023 until 30 June 2023. | 12/01/2023 | The product does not meet the pH requirements of British Pharmacopoeia | The product does not meet the pH requirements in the monograph | 1. A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 15 July 2022 will be supplied with each affected batch 2. The TGA must be inform immediately by writing to the decision delegate if any batch of the product(s) is analysed and the results obtained for pH are greater than or equal to pH 9.0. | import and supply | Prescription medicines | |
| PHENERGAN promethazine hydrochloride 10 mg tablet blister pack (reformulation) | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 80159 | 245230A | CON-1062 | The consent is effective from 9 January 2023 until batch 245230A is exhausted | 9/01/2023 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product does not comply because the labels display the previous sponsor name/contact details that are slightly different to the new sponsor name/contact details. | supply | Over-the-counter medicines | |
| TETRABENAZINE SUN tetrabenazine 25 mg tablet bottle | Sun pharma ANZ Pty Ltd | 381235 | DND1109BR and DNC1348AR | CON-1059 | The consent is effective from 9 January 2023 until affected Batches DND1109BR and DNC 1348AR are exhausted. | 9/01/2023 | Section 8(2) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) label does not include the correct dispensing label space. | import and supply | Prescription medicines | |
| VIAGRA sildenafil (as citrate) 50 mg tablet blister pack | Viatris Pty Ltd | 64435 | B700013 | CON-1061 | The consent is effective from 6 January 2023 until 6 January 2024. | 6/01/2023 | Section 8 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) blister does not include the prefixes for batch number and expiry date. | A ‘Dear Healthcare Provider’ letter identical to that provided to the TGA on 14 November 2022 will be supplied with each affected batch. | import and supply | Prescription medicines |
| BICILLIN L-A-benzathine benzylpenicillin tetrahydrate 600,000 units/1.17 mL suspension for injection syringe with needle | Pfizer Australia Pty Ltd | 293456 | FC3933 | CON-1060 | The consent is effective from 6 January 2023 until 6 January 2025. | 6/01/2023 | United States Pharmacopeia-National Formulary (USP-NF) monograph for Lecithin of United States Pharmacopoeia | The products do not meet the specification for ‘Assay: Content of Phospholipids’ of NLT 70.0% for phosphatidylcholine | import and supply | Prescription medicines | |
| BICILLIN L-A benzathine benzylpenicillin tetrahydrate 1,200,000 Units / 2.3 mL suspension for injection pre-filled syringe with needle | Pfizer Australia Pty Ltd | 147169 | FT9667, GJ9969 and GM8084 | CON-1060 | The consent is effective from 6 January 2023 until 6 January 2025. | 6/01/2023 | United States Pharmacopeia-National Formulary (USP-NF) monograph for Lecithin of United States Pharmacopoeia | The products do not meet the specification for ‘Assay: Content of Phospholipids’ of NLT 70.0% for phosphatidylcholine | import and supply | Prescription medicines | |
| TRAVACALM H.O. Chewable hyoscine hydrobromide 300 micrograms tablet strip pack | Key Pharmaceuticals Pty Ltd | 68450 | PB10670 and PB10671 | CON-1052 | The consent is effective from 1 January 2023 until 31 December 2024. | 1/01/2023 | subsection 10(4) of Therapeutic Goods (Medicines - Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021 | The products do not comply as the carton label includes a 2D data matrix code; however, the human readability formatting requirements are not compliant because the Global Trade Item Number (GTIN) and serial number are only identified by the application identifier (01) and (21) instead of GTIN and S/N. | import and supply | Over-the-counter medicines | |
| ALEPAM 30 oxazepam 30 mg tablet blister pack | Alphapharm Pty Ltd | 385082 | 8145371 and 8149184 | CON-1058 | The consent is effective from the date of this letter until the affected batches are exhausted. | 21/12/2022 | Paragraph 9(1)(d) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) incorrectly refer to the dosage form as “film coated tablets” whereas the correct dosage form is “tablets”. | import and supply | Prescription medicines | |
| PANADOL CHILDREN 5 - 12 YEARS paracetamol 48 mg/mL oral suspension bottle (Orange - Colourfree) | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd t/a Haleon | 178303 | CON-1056 | The consent is effective from 19 December 2022 until 1 January 2024. | 19/12/2022 | Test and limits for “Deliverable volume <698>” of United States Pharmacopoeia | The products that do not conform to the requirements of the USP with respect to test and limits for “Deliverable volume <698>”. | supply | Over-the-counter medicines | ||
| PANADOL CHILDREN 5 - 12 YEARS paracetamol 48 mg/mL oral suspension bottle (Strawberry - Colourfree) | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd t/a Haleon | 178302 | CON-1056 | The consent is effective from 19 December 2022 until 1 January 2024. | 19/12/2022 | Test and limits for “Deliverable volume <698>” of United States Pharmacopoeia | The products that do not conform to the requirements of the USP with respect to test and limits for “Deliverable volume <698>”. | supply | Over-the-counter medicines | ||
| OLANZAPINE SANDOZ olanzapine 7.5 mg film coated tablet, blister pack | Sandoz Pty Ltd | 148474 | CON-1055 | The consent is effective from 19 December 2022 until 19 December 2023. | 19/12/2022 | of United States Pharmacopoeia | The products that do not conform to the requirements of Olanzapine Tablets BP or USP monograph, in that • the method equivalency of in-house Dissolution, Assay and Related Substances methods with the official standard when tested by the methods specified by the standard have not been established. | import and supply | Prescription medicines | ||
| OLANZAPINE SANDOZ olanzapine 5 mg film coated tablet, blister pack | Sandoz Pty Ltd | 148469 | CON-1055 | The consent is effective from 19 December 2022 until 19 December 2023. | 19/12/2022 | of United States Pharmacopoeia | The products that do not conform to the requirements of Olanzapine Tablets BP or USP monograph, in that • the method equivalency of in-house Dissolution, Assay and Related Substances methods with the official standard when tested by the methods specified by the standard have not been established. | import and supply | Prescription medicines | ||
| OLANZAPINE SANDOZ olanzapine 10 mg film coated tablet, blister pack | Sandoz Pty Ltd | 148451 | CON-1055 | The consent is effective from 19 December 2022 until 19 December 2023. | 19/12/2022 | of United States Pharmacopoeia | The products that do not conform to the requirements of Olanzapine Tablets BP or USP monograph, in that • the method equivalency of in-house Dissolution, Assay and Related Substances methods with the official standard when tested by the methods specified by the standard have not been established. | import and supply | Prescription medicines | ||
| OLANZAPINE SANDOZ olanzapine 2.5 mg film coated tablet, blister pack | Sandoz Pty Ltd | 148450 | CON-1055 | The consent is effective from 19 December 2022 until 19 December 2023. | 19/12/2022 | of United States Pharmacopoeia | The products that do not conform to the requirements of Olanzapine Tablets BP or USP monograph, in that • the method equivalency of in-house Dissolution, Assay and Related Substances methods with the official standard when tested by the methods specified by the standard have not been established. | import and supply | Prescription medicines | ||
| Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Matrix - Implant - Pouch | Medtronic Australasia Pty Ltd | 229636 | CON-1054 | The consent is effective from 16 December 2022 until 21 June 2023. | 16/12/2022 | clause 11(18) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products do not conform with clause 11(18) of TGO 108 that specifies that the serum or plasma of a blood sample taken from a donor of HCT materials must be retained for a minimum of two years after the expiry date of the relevant HCT product, or for a period that is validated on the basis of validated data or documented evidence from relevant scientific literature. | import and supply | Prescription medicines | ||
| Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton Plus DBM Paste - Implant - Syringe | Medtronic Australasia Pty Ltd | 229635 | CON-1054 | The consent is effective from 16 December 2022 until 21 June 2023. | 16/12/2022 | clause 11(18) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products do not conform with clause 11(18) of TGO 108 that specifies that the serum or plasma of a blood sample taken from a donor of HCT materials must be retained for a minimum of two years after the expiry date of the relevant HCT product, or for a period that is validated on the basis of validated data or documented evidence from relevant scientific literature. | import and supply | Prescription medicines | ||
| Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Flex - Implant - Pouch | Medtronic Australasia Pty Ltd | 229634 | CON-1054 | The consent is effective from 16 December 2022 until 21 June 2023. | 16/12/2022 | clause 11(18) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products do not conform with clause 11(18) of TGO 108 that specifies that the serum or plasma of a blood sample taken from a donor of HCT materials must be retained for a minimum of two years after the expiry date of the relevant HCT product, or for a period that is validated on the basis of validated data or documented evidence from relevant scientific literature. | import and supply | Prescription medicines | ||
| Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Orthoblend - Implant - Jar/Can | Medtronic Australasia Pty Ltd | 229633 | CON-1054 | The consent is effective from 16 December 2022 until 21 June 2023. | 16/12/2022 | clause 11(18) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The products do not conform with clause 11(18) of TGO 108 that specifies that the serum or plasma of a blood sample taken from a donor of HCT materials must be retained for a minimum of two years after the expiry date of the relevant HCT product, or for a period that is validated on the basis of validated data or documented evidence from relevant scientific literature. | import and supply | Prescription medicines | ||
| Aquacare/HP Urea 100 mg/g Cream | Allergan Australia Pty Ltd | 23199 | CON-1051 | The consent is effective from 12 December 2022 until 12 December 2023. | 12/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the previous address of the sponsor instead of the current address of the sponsor | import and supply | Over-the-counter medicines | ||
| ALBALON naphazoline hydrochloride 1mg/mL eye drop bottle | Allergan Australia Pty Ltd | 23197 | CON-1051 | The consent is effective from 12 December 2022 until 12 December 2023. | 12/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the previous address of the sponsor instead of the current address of the sponsor | import and supply | Over-the-counter medicines | ||
| ALBALON-A eye drop bottle | Allergan Australia Pty Ltd | 23091 | CON-1051 | The consent is effective from 12 December 2022 until 12 December 2023. | 12/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the previous address of the sponsor instead of the current address of the sponsor | import and supply | Over-the-counter medicines | ||
| ENDURA PERFORMANCE HYDRATION PINEAPPLE | Metagenics (Aust) Pty Ltd | 338671 | CON-1053 | The consent is effective from 9 December 2022 until 1 October 2026. | 9/12/2022 | subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text | 1. The exemption only applies to the ‘ENDURA’ distinguishing mark used as a component of the medicine name for each aforementioned product. Specifically: The tagline ‘SPORTS NUTRITION’ positioned directly below the word ‘ENDURA’, which separates ‘ENDURA’ from the rest of the name of the medicine | supply | Listed complementary medicines | |
| ENDURA PERFORMANCE HYDRATION ORANGE | Metagenics (Aust) Pty Ltd | 375078 | CON-1053 | The consent is effective from 9 December 2022 until 1 October 2026. | 9/12/2022 | subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text | 1. The exemption only applies to the ‘ENDURA’ distinguishing mark used as a component of the medicine name for each aforementioned product. Specifically: The tagline ‘SPORTS NUTRITION’ positioned directly below the word ‘ENDURA’, which separates ‘ENDURA’ from the rest of the name of the medicine | supply | Listed complementary medicines | |
| ENDURA LOW CARB HYDRATION TROPICAL PUNCH | Metagenics (Aust) Pty Ltd | 374902 | CON-1053 | The consent is effective from 9 December 2022 until 1 October 2026. | 9/12/2022 | subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text | 1. The exemption only applies to the ‘ENDURA’ distinguishing mark used as a component of the medicine name for each aforementioned product. Specifically: The tagline ‘SPORTS NUTRITION’ positioned directly below the word ‘ENDURA’, which separates ‘ENDURA’ from the rest of the name of the medicine | supply | Listed complementary medicines | |
| ENDURA LOW CARB HYDRATION LEMON LIME | Metagenics (Aust) Pty Ltd | 374312 | CON-1053 | The consent is effective from 9 December 2022 until 1 October 2026. | 9/12/2022 | subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text | 1. The exemption only applies to the ‘ENDURA’ distinguishing mark used as a component of the medicine name for each aforementioned product. Specifically: The tagline ‘SPORTS NUTRITION’ positioned directly below the word ‘ENDURA’, which separates ‘ENDURA’ from the rest of the name of the medicine | supply | Listed complementary medicines | |
| Bondi Sands Mineral Zinc Sunscreen SPF50+ Body Lotion | Bondi Sands Pty Ltd | 386666 | CON-1050 | The consent is effective from 9 December 2022 until 28 February 2023. | 9/12/2022 | Ph. Eur. monograph 2584 of European Pharmacopoeia | The products do not comply because they don’t meet the requirements for ID test B – Hydroxyl Value and the Acid Value test, as the results are higher than the limit. | The accelerated and real time testing will continue on the impacted batches and any out of specification results observed during this stability testing will be reported to the Therapeutics Goods Administration. | supply | Listed complementary medicines | |
| Bondi Sands Mineral Zinc Sunscreen SPF50+ Face Lotion | Bondi Sands Pty Ltd | 386665 | CON-1050 | The consent is effective from 9 December 2022 until 28 February 2023. | 9/12/2022 | Ph. Eur. monograph 2584 of European Pharmacopoeia | The products do not comply because they don’t meet the requirements for ID test B – Hydroxyl Value and the Acid Value test, as the results are higher than the limit. | The accelerated and real time testing will continue on the impacted batches and any out of specification results observed during this stability testing will be reported to the Therapeutics Goods Administration. | supply | Listed complementary medicines | |
| Key Sun Clear Zinke Mineral SPF50+ | Key-Sun Laboratories Pty Ltd | 386778 | CON-1049 | The consent is effective from 9 December 2022 until 28 February 2023. | 9/12/2022 | Ph. Eur. monograph 2584 of European Pharmacopoeia | The product does not comply because they don’t meet the requirements for ID test B – Hydroxyl Value and the Acid Value test, as the results are higher than the limit. | Accelerated and real time testing will continue on the impacted batches and any out of specification results observed during this stability testing will be reported to the TGA. | supply | Listed complementary medicines | |
| Sun Zapper Pure Zinc Sunscreen SPF50+ | Sun Zapper Sun Care Pty Ltd | 385945 | CON-1048 | The consent is effective from 9 December 2022 until 28 February 2023. | 9/12/2022 | Ph. Eur. monograph 2584 of European Pharmacopoeia | The product does not comply because it does not meet the requirements for ID test B – Hydroxyl Value and the Acid Value test, as the results are higher than the limit. | Accelerated and real time stability testing will continue on the impacted batches and any out of specification results observed during this stability testing will be reported to the TGA. | supply | Listed complementary medicines | |
| Ombra Sensitive With Zinc Sunscreen Lotion SPF50+ | Ross Laboratories Aust Pty Ltd | 387125 | CON-1047 | The consent is effective from 9 December 2022 until 28 February 2023. | 9/12/2022 | Ph. Eur. monograph 2584 of European Pharmacopoeia | The product does not comply because it does not meet the requirements for ID test B – Hydroxyl Value and the Acid Value test, as the results are higher than the limit. | The accelerated and real time stability testing will continue on the impacted batches and any out of specification results observed during this stability testing will be reported to the Therapeutics Goods Administration. | supply | Listed complementary medicines | |
| Natural Instinct Kids SPF50+ Clean Sunscreen | Mentholatum Australasia Pty Ltd | 395312 | CON-1046 | The consent is effective from 9 December 2022 until 28 February 2023. | 9/12/2022 | Ph. Eur. Monograph 2584 of European Pharmacopoeia | The product does not comply because it does not meet the requirements for ID test B – Hydroxyl Value and the Acid Value test, as the results are higher than the limit. | Accelerated and real time stability testing will continue on the impacted batches and any out of specification results observed during this stability testing will be reported to the TGA. | supply | Listed complementary medicines | |
| REVLIMID lenalidomide 5 mg capsule blister pack | Celgene Pty Ltd | 132510 | CON-1045 | The consent is effective from 7 December 2022 until 28 November 2024. | 7/12/2022 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) labels refer to the previous registered address of the sponsor. | 1. The labels to which this consent applies are those previously approved with the previous sponsor address. | supply | Prescription medicines | |
| REVLIMID lenalidomide 10 mg capsule blister pack | Celgene Pty Ltd | 132514 | CON-1045 | The consent is effective from 7 December 2022 until 28 November 2024. | 7/12/2022 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) labels refer to the previous registered address of the sponsor. | 1. The labels to which this consent applies are those previously approved with the previous sponsor address. | supply | Prescription medicines | |
| REVLIMID lenalidomide 25 mg capsule blister pack | Celgene Pty Ltd | 132516 | CON-1045 | The consent is effective from 7 December 2022 until 28 November 2024. | 7/12/2022 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) labels refer to the previous registered address of the sponsor. | 1. The labels to which this consent applies are those previously approved with the previous sponsor address. | supply | Prescription medicines | |
| REVLIMID lenalidomide 15 mg capsule blister pack | Celgene Pty Ltd | 132515 | CON-1045 | The consent is effective from 7 December 2022 until 28 November 2024. | 7/12/2022 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) labels refer to the previous registered address of the sponsor. | 1. The labels to which this consent applies are those previously approved with the previous sponsor address. | supply | Prescription medicines | |
| THALOMID thalidomide 50 mg hard capsule blister pack | Celgene Pty Ltd | 156729 | CON-1045 | The consent is effective from 7 December 2022 until 28 November 2024. | 7/12/2022 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) labels refer to the previous registered address of the sponsor. | 1. The labels to which this consent applies are those previously approved with the previous sponsor address. | supply | Prescription medicines | |
| THALOMID thalidomide 100 mg hard capsule blister pack | Celgene Pty Ltd | 156902 | CON-1045 | The consent is effective from 7 December 2022 until 28 November 2024. | 7/12/2022 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) labels refer to the previous registered address of the sponsor. | 1. The labels to which this consent applies are those previously approved with the previous sponsor address. | supply | Prescription medicines | |
| VIDAZA azacitidine 100 mg powder for injection | Celgene Pty Ltd | 153080 | CON-1045 | The consent is effective from 7 December 2022 until 28 November 2024. | 7/12/2022 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) labels refer to the previous registered address of the sponsor. | 1. The labels to which this consent applies are those previously approved with the previous sponsor address. | supply | Prescription medicines | |
| POMALYST pomalidomide 1 mg capsule blister pack | Celgene Pty Ltd | 212657 | CON-1045 | The consent is effective from 7 December 2022 until 28 November 2024. | 7/12/2022 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) labels refer to the previous registered address of the sponsor. | 1. The labels to which this consent applies are those previously approved with the previous sponsor address. | supply | Prescription medicines | |
| POMALYST pomalidomide 3 mg capsule blister pack | Celgene Pty Ltd | 212656 | CON-1045 | The consent is effective from 7 December 2022 until 28 November 2024. | 7/12/2022 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) labels refer to the previous registered address of the sponsor. | 1. The labels to which this consent applies are those previously approved with the previous sponsor address. | supply | Prescription medicines | |
| POMALYST pomalidomide 4 mg capsule blister pack | Celgene Pty Ltd | 212655 | CON-1045 | The consent is effective from 7 December 2022 until 28 November 2024. | 7/12/2022 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) labels refer to the previous registered address of the sponsor. | 1. The labels to which this consent applies are those previously approved with the previous sponsor address. | supply | Prescription medicines | |
| POMALYST pomalidomide 2 mg capsule blister pack | Celgene Pty Ltd | 212654 | CON-1045 | The consent is effective from 7 December 2022 until 28 November 2024. | 7/12/2022 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) labels refer to the previous registered address of the sponsor. | 1. The labels to which this consent applies are those previously approved with the previous sponsor address. | supply | Prescription medicines | |
| Immunity Orange Zest | Procter and Gamble Australia Pty Ltd | 343585 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Vitamin C | Procter and Gamble Australia Pty Ltd | 313180 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Collagen | Procter and Gamble Australia Pty Ltd | 318054 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Hydrate Orange | Procter and Gamble Australia Pty Ltd | 321236 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Vitamin D | Procter and Gamble Australia Pty Ltd | 322266 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Iron + Vitamin C | Procter and Gamble Australia Pty Ltd | 324166 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Magnesium | Procter and Gamble Australia Pty Ltd | 325773 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Performance | Procter and Gamble Australia Pty Ltd | 326346 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Hydrate Apple + Berry | Procter and Gamble Australia Pty Ltd | 326355 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Sport Lemon + Lime | Procter and Gamble Australia Pty Ltd | 327124 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Sport Orange | Procter and Gamble Australia Pty Ltd | 327132 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Sport Berry | Procter and Gamble Australia Pty Ltd | 327133 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Magnesium Forte | Procter and Gamble Australia Pty Ltd | 329278 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Energy | Procter and Gamble Australia Pty Ltd | 330143 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Vitamin B+ | Procter and Gamble Australia Pty Ltd | 330981 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Immunity Blackcurrant | Procter and Gamble Australia Pty Ltd | 338210 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Kids Immunity | Procter and Gamble Australia Pty Ltd | 339911 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Kids Multivitamin | Procter and Gamble Australia Pty Ltd | 340864 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Multivitamin | Procter and Gamble Australia Pty Ltd | 341699 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Mega B Complex | Procter and Gamble Australia Pty Ltd | 346336 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Calcium Plus | Procter and Gamble Australia Pty Ltd | 346494 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Zinc Plus | Procter and Gamble Australia Pty Ltd | 347980 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Vitamin C Elderberry Flavour | Procter and Gamble Australia Pty Ltd | 366796 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Hydrate Lemon + Lime | Procter and Gamble Australia Pty Ltd | 371178 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Kids Calcium | Procter and Gamble Australia Pty Ltd | 371179 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Multivitamin Berry | Procter and Gamble Australia Pty Ltd | 371992 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| Energy Raspberry | Procter and Gamble Australia Pty Ltd | 371993 | CON-1044 | The consent is effective from 6 December 2022 until 1 June 2023. | 6/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because they contain the name and contact details of the previous sponsor. | There are arrangements in place with the Vitaminhaus Pty Ltd [the former sponsor] for the prompt referral of any queries or complaints concerning the products to Procter & Gamble Australia [the current sponsor]. | import, supply, and export | Listed complementary medicines | |
| SCHOLL CALLUS REMOVAL PADS salicylic acid 400 mg/g dressing - medicated sachet | Scholls Wellness Company Pty Ltd | 13517 | CON-1043 | The consent is effective from 5 December 2022 until 5 December 2023. | 5/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the contact details for the previous sponsor (Reckitt Benckiser Pty Ltd) instead of the contact details for the new sponsor (Scholls Wellness Company Pty Ltd). | Import and supply | Over-the-counter medicines | ||
| SCHOLL WART REMOVAL SYSTEM salicylic acid 400 mg/g medicated dressing sachet | Scholls Wellness Company Pty Ltd | 53606 | CON-1043 | The consent is effective from 5 December 2022 until 5 December 2023. | 5/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the contact details for the previous sponsor (Reckitt Benckiser Pty Ltd) instead of the contact details for the new sponsor (Scholls Wellness Company Pty Ltd). | Import and supply | Over-the-counter medicines | ||
| SCHOLL CORN REMOVAL PADS salicylic acid 400 mg/g dressing - medicated sachet | Scholls Wellness Company Pty Ltd | 13518 | CON-1043 | The consent is effective from 5 December 2022 until 5 December 2023. | 5/12/2022 | paragraph 8(1)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the labels display the contact details for the previous sponsor (Reckitt Benckiser Pty Ltd) instead of the contact details for the new sponsor (Scholls Wellness Company Pty Ltd). | Import and supply | Over-the-counter medicines | ||
| EVUSHELD tixagevimab 100 mg/mL and cilgavimab 100 mg/mL solution for injection in 150 mg single dose vials | AstraZeneca Pty Ltd | 378245 | CON-1030 | The consent is effective from 1 December 2022 until 31 December 2023. | 1/12/2022 | section 6, paragraph 8(1)(d), paragraph 8(1)(i), subsection 8(2), paragraph 9(1)(d), paragraph 9(3)(a) and (b), subsection 9(5), paragraph 10(4)(f). of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | • section 6: the excipients 'L-histidine' and 'L-histidine hydrochloride monohydrate' are not named as per the Australian Approved Names • paragraph 8(1)(d): the dosage form 'solution for injection' is shown as ' injection' and 'each 1.5 mL of solution contains…' • paragraph 8(1)(i): the sponsor address is not included as they are international artworks. Details can be found by scanning the QR code or going to 'laab.azcovid-19.com' • subsection 8(2): the international cartons don't include a dispensing label • paragraph 9(1)(d): 'injection' is included on the main panel and 'solution' is included on the back panel as part of 'each 1.5mL of solution contains…' • paragraphs 9(3)(a) and (b): the name of the medicine, active ingredient and quantity are not presented in the required cohesive layout • subsection 9(5): the name of the active ingredients and quantity have a text height of less than 3.0 millimetres • paragraph 10(4)(f): the dosage form is described as 'injection' on the vial labels. | Import and supply | Prescription medicines | ||
| IKERVIS ciclosporin 1 mg/mL eye drops emulsion ampoule | Seqirus Pty Ltd | 319502 | CON-1038 | The consent is effective from 23 November 2022 until 23 November 2023. | 23/11/2022 | paragraphs 8(3)(d), 8(3)(e) and 10(12)(d) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product batch number prefix is not printed immediately before the batch number on the carton label, the expiry date prefix is not printed immediately before the expiry date on the carton label, and the batch number and expiry date prefixes are not included on the ampoule label. | 1. The carton label must include the batch number and expiry date prefixes in immediate proximity to the batch number and expiry date (as outlined in the application). 2. The ampoule labels must include the batch number and expiry date. 3. The associated pouch labels must include the batch number and expiry date immediately after their respective prefixes. 4. The associated carton and pouch labels must include instructions that unused ampoules must be stored in the associated pouch. | import and supply | Prescription medicines | |
| Cellular Therapies - T Cells - Brexucabtagene autoleucel, cryopreserved - T - Tecartus - Injection, intravenous infusion - Bag | Gilead Sciences Pty Ltd | 396794 | CON-1037 | The consent is effective from 23 November 2022 until 30 April 2023. | 23/11/2022 | TGO 107: Schedule 2, Part 1, Item 6 of Therapeutic Goods (Standard for Biologicals - Labelling Requirements) (TGO 107) Order 2021 | The product does not conform to the requirements of Schedule 2, Part 1, Item 6 of TGO 107 in that the name of the sponsor of the biological is not on the product label attached to the container. | import and supply | Blood, tissues, and biologicals | ||
| OROXINE levothyroxine sodium 100 microgram tablet blister pack | Company X | 125499 | AP-009681 DD899 | CON-389 | The consent is effective from 21 November 2022 until 21 November 2023. | 21/11/2022 | Section 9(a)(iii)(ggg) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021 | The product doesn't include the company contact details on the label. | import and supply | Prescription medicines | |
| ACETYLCYSTEINE-LINK INJECTION acetylcysteine 2 g/10 mL concentrated injection ampoule | Link Medical Products Pty Ltd TA Link Pharmaceuticals | 170803 | CON-1036 | The consent is effective from 18 November 2022 until 1 November 2024. | 18/11/2022 | of British Pharmacopoeia | The product does not meet the BP Acetylcysteine Injection monograph limit for L-cysteine | import and supply | Prescription medicines | ||
| PROVERA medroxyprogesterone acetate 500 mg tablet blister pack | Pfizer Australia Pty Ltd | 12336 | FY8343, FH3873 & ED6832 | CON-1035 | The consent is effective from 18 November 2022 until 18 November 2023. | 18/11/2022 | Standard for labels of prescription and related medicines (TGO 91) Paragraph 8(1)(j) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product carton labels do not include the declaration of benzoates being present in the medicine | 1. a ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 26 October 2022 will be supplied with each affected batch. 2. The Company must inform Therapeutic Goods Administration of the batch number for the one referenced batch of AUST R 12331 with batch number not currently known to which this consent is requested (letter of 14 November 2022), prior to supplying the affected batch. | import and supply | Prescription medicines |
| PROVERA medroxyprogesterone acetate 250 mg tablet blister pack | Pfizer Australia Pty Ltd | 12334 | FW9600, FR4755 & FE6336 | CON-1035 | The consent is effective from 18 November 2022 until 18 November 2023. | 18/11/2022 | Standard for labels of prescription and related medicines (TGO 91) Paragraph 8(1)(j) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product carton labels do not include the declaration of benzoates being present in the medicine | 1. a ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 26 October 2022 will be supplied with each affected batch. 2. The Company must inform Therapeutic Goods Administration of the batch number for the one referenced batch of AUST R 12331 with batch number not currently known to which this consent is requested (letter of 14 November 2022), prior to supplying the affected batch. | import and supply | Prescription medicines |
| PROVERA medroxyprogesterone acetate 200 mg tablet blister pack | Pfizer Australia Pty Ltd | 12333 | FW7855, FA1126, GK6319 & DP0015 | CON-1035 | The consent is effective from 18 November 2022 until 18 November 2023. | 18/11/2022 | Standard for labels of prescription and related medicines (TGO 91) Paragraph 8(1)(j) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product carton labels do not include the declaration of benzoates being present in the medicine | 1. a ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 26 October 2022 will be supplied with each affected batch. 2. The Company must inform Therapeutic Goods Administration of the batch number for the one referenced batch of AUST R 12331 with batch number not currently known to which this consent is requested (letter of 14 November 2022), prior to supplying the affected batch. | import and supply | Prescription medicines |
| PROVERA medroxyprogesterone acetate 100 mg tablet blister pack | Pfizer Australia Pty Ltd | 12331 | GD9405, FR3315, ER1782, ER2778, EG9425, GL0803 & DW2135 | CON-1035 | The consent is effective from 18 November 2022 until 18 November 2023. | 18/11/2022 | Standard for labels of prescription and related medicines (TGO 91) Paragraph 8(1)(j) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product carton labels do not include the declaration of benzoates being present in the medicine | 1. a ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 26 October 2022 will be supplied with each affected batch. 2. The Company must inform Therapeutic Goods Administration of the batch number for the one referenced batch of AUST R 12331 with batch number not currently known to which this consent is requested (letter of 14 November 2022), prior to supplying the affected batch. | import and supply | Prescription medicines |
| Formula IV Plus - New | NeoLife International Pty Ltd | 274389 | CON-1032 | The consent is effective from 10 November 2022 until 30 November 2024. | 10/11/2022 | TGO 92 Standard for labels of non-prescription medicines - subparagraphs 10(8)(a)(vi) and 10(8)(a)(vii) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product does not comply because the individual unit wrapper (intermediate packaging) does not include the names and quantities of all active ingredients in the medicine. | The outer carton (primary packaging) must include a statement indicating that each individually wrapped unit must be kept inside the carton prior to the time of consumption. The Company may choose the following statements on your labels or wordings along those lines. ‘Do not remove from primary packaging before use’; or ‘Store in original outer packaging until use’ | import and supply | Listed complementary medicines | |
| Faecal microbiota, frozen - L - Biomictra | BiomeBank | CON-1033 | The consent is effective from 9 November 2022 until 9 November 2023 and is only applicable to batches manufactured before 16 November 2022 with the name BiomeBoost. | 9/11/2022 | TGO 107 - Standard for Biologicals -Labelling Requirements (TGO 107) clause 10(1)(a) of Therapeutic Goods (Standard for Biologicals - Labelling Requirements) (TGO 107) Order 2021 | The products do not conform with clause 10(1)(a) of TGO 107 in that Schedule 2 Part 1 Item 3 states that the product type or name must be on or attached to the container and primary pack. The trade name BiomeBoost is on the label instead of the approved trade name Biomictra. | 1. ‘Dear Healthcare Professional’ letter identical to that provided to the Therapeutic Goods Administration will be supplied with each affected batch explaining the name change. 2. BiomeBank will supply the released batch numbers and date of release to the Therapeutic Goods Administration (via email) within 30 days of the release. | supply | Blood, tissues, and biologicals | ||
| All blood components as per the Lifeblood Technical Master File | Australian Red Cross Lifeblood | CON-1031 | The consent is effective from 4 November 2022 until 9 November 2024. | 4/11/2022 | Council of Europe Guide to the Preparation, Use and Quality Assurance of Blood Components 19th edition: Chapter 2 Principles of donor selection, Apheresis donors (Page 146): ‘Haemoglobin levels should be determined at each donation. The minimum value for plasmapheresis should be 120 g/L and 130 g/L for female and male donors, respectively.’ Chapter 2 Standards for selection of donors, Whole blood donors (page 259): • Haemoglobin concentration must be determined each time the donor attends to donate blood or blood components. • Minimum values before donation: o female donors: 125 g/L or 7. 8 mmol/L (minimum haematocrit = 0.38) o male donors: 135 g/L or 8. 4 mmol/L (minimum haematocrit = 0.4) • Individual donations may be accepted below these levels after consultation with the responsible physicians or as established by a Competent Authority, based on norms for their specific populations. of Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019 | The products may not comply with the requirements of TGO 102 as blood and apheresis donors are currently accepted with haemoglobin levels below those levels described in the standard. Lifeblood donor haemoglobin acceptable ranges, previously agreed after consultation with the TGA and in place since 2004, are: Apheresis - Female: 115-165g/L, Male: 125-185 g/L Whole blood - Female: 120-165g/L, Male: 130-185 g/L | 1. A condition of this consent is that during the exemption Lifeblood will submit to TGA six monthly updates outlining progress on implementation of a strategy for measuring donor ferritin levels. | supply | Blood, tissues, and biologicals | ||
| Pfizer (Australia) MIDAZOLAM INJECTION midazolam 5 mg/1 mL injection ampoule | Pfizer Australia Pty Ltd | 72213 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) MIDAZOLAM INJECTION midazolam 50 mg/10 mL injection ampoule | Pfizer Australia Pty Ltd | 72207 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| HEPARINISED SALINE 50 IU/5 mL (porcine mucous) injection ampoule | Pfizer Australia Pty Ltd | 66684 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) LEUCOVORIN CALCIUM folinic acid (as calcium folinate) 100 mg/10 mL injection USP ampoule | Pfizer Australia Pty Ltd | 61887 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) LEUCOVORIN CALCIUM folinic acid (as calcium folinate) 50 mg/5 mL injection USP ampoule | Pfizer Australia Pty Ltd | 61885 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) CHLORHEXIDINE 0.015% Cetrimide 0.15% irrigation solution ampoule | Pfizer Australia Pty Ltd | 57021 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) CHLORHEXIDINE 0.05% Cetrimide 0.5% irrigation solution ampoule | Pfizer Australia Pty Ltd | 57011 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) LIGNOCAINE HYDROCHLORIDE 1% (200 mg/20 mL) injection BP ampoule | Pfizer Australia Pty Ltd | 49297 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) LIGNOCAINE HYDROCHLORIDE 1% (50 mg/5 mL) injection BP ampoule | Pfizer Australia Pty Ltd | 49296 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) LIGNOCAINE HYDROCHLORIDE 2% (400 mg/20 mL) injection BP ampoule | Pfizer Australia Pty Ltd | 49295 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) LIGNOCAINE HYDROCHLORIDE 2% (100 mg/5 mL) injection BP ampoule | Pfizer Australia Pty Ltd | 49293 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) WATER FOR INJECTION 20 mL BP ampoule | Pfizer Australia Pty Ltd | 49288 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) WATER FOR INJECTION 10 mL BP ampoule | Pfizer Australia Pty Ltd | 49287 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) WATER FOR INJECTION 5 mL BP ampoule | Pfizer Australia Pty Ltd | 49286 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) WATER FOR INJECTION 2 mL BP ampoule | Pfizer Australia Pty Ltd | 49284 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) SODIUM CHLORIDE 0.9% (180 mg/20 mL) injection BP ampoule | Pfizer Australia Pty Ltd | 49279 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) SODIUM CHLORIDE 0.9% (90 mg/10 mL) injection BP ampoule | Pfizer Australia Pty Ltd | 49278 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) SODIUM CHLORIDE 0.9% (45 mg/ 5mL) injection BP ampoule | Pfizer Australia Pty Ltd | 49272 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| HEPARIN SODIUM 25000 IU/5 mL (porcine mucous) injection ampoule | Pfizer Australia Pty Ltd | 49236 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| HEPARIN SODIUM 5000 IU/5 mL (porcine mucous) injection ampoule | Pfizer Australia Pty Ltd | 49232 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| CYKLOKAPRON tranexamic acid 1000 mg/10 mL solution for injection ampoule | Pfizer Australia Pty Ltd | 166415 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) GENTAMICIN 80 mg/2 mL (as sulfate) injection BP ampoule | Pfizer Australia Pty Ltd | 11376 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) CHLORHEXIDINE 0.2% CATHETER PREP Irrigation Solution ampoule | Pfizer Australia Pty Ltd | 11324 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) BUPIVACAINE HYDROCHLORIDE 0.5% (50 mg/10 mL) injection BP ampoule | Pfizer Australia Pty Ltd | 11312 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Perth) ATROPINE INJECTION BP atropine sulfate monohydrate 1.2 mg/1 mL injection BP ampoule | Pfizer Australia Pty Ltd | 11303 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Perth) ATROPINE INJECTION BP atropine sulfate monohydrate 600 microgram/1 mL injection BP ampoule | Pfizer Australia Pty Ltd | 11302 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) SODIUM CHLORIDE 0.9% irrigation solution ampoule | Pfizer Australia Pty Ltd | 11290 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) CHLORHEXIDINE 0.1% irrigation solution ampoule | Pfizer Australia Pty Ltd | 11175 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| Pfizer (Australia) STERILE POTASSIUM CHLORIDE CONCENTRATE potassium chloride 750 mg/10 mL injection ampoule | Pfizer Australia Pty Ltd | 10793 | CON-1029 | The consent is effective from 1 November 2022 until 1 November 2023. | 1/11/2022 | Various sections of Therapeutic Goods Order No. 91 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product has print direct stamped onto the plastic ampoules (TECA print) and comply with the requirements of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69) | import and supply | Prescription medicines | ||
| NATULAN procarbazine 50 mg (as hydrochloride) capsule blister pack | Link Medical Products Pty Ltd TA Link Pharmaceuticals | 231199 | CON-1027 | The consent is effective from 1 November 2022 until 1 November 2024. | 1/11/2022 | Subparagraphs 10(14)a(vii), 10(14)a(viii) and 10(14)a(ix) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product blister foil does not have the batch number and expiry date prefixes preceding the batch numbers and expiry dates respectively, or the name of the sponsor or distributor, or registered trademark of the sponsor or distributor. | a ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 13 October 2022 will be supplied with each affected batch. | import and supply | Prescription medicines | |
| ONCASPAR pegaspargase 3750 units/5 mL powder for solution injection/infusion vial | Servier Laboratories (Aust) Pty Ltd | 303807 | CON-1028 | The consent is effective from 28 October 2022 until 31 March 2023. | 28/10/2022 | subsection 7(1) and Section 8 of TGO 91. of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product does not meet the requirements of TGO 91 subsection 7(1) because the container and primary pack do not bear a label that meets the requirements of TGO 91. | The current registered Australian product label will be included in a clear zip-lock bag containing one unit of the product, a ‘Dear Healthcare Professional’ letter identical to that provided to the Therapeutic Goods Administration on 27 October 2022 and a copy of the ONCASPAR Australian-approved Product Information document. | import and supply | Prescription medicines | |
| PEMETREXED EVER PHARMA pemetrexed (as disodium) 1000 mg/40 mL concentrated solution for infusion vial | InterPharma Pty Ltd | 372329 | CON-1026 | The consent is effective from 20 October 2022 until 17 October 2024. | 20/10/2022 | paragraphs 8(1)(h), 8(1)(i) and 8(1)(n) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product vial label does not include storage conditions, the product vial label does not include contact details of the sponsor, and the product vial label does not contain a machine-readable code. | a. Conditions applicable to all registered therapeutic goods as specified in the document Standard Conditions Applying to Registered or Listed Therapeutic Goods under Section 28 of the Therapeutic Goods Act 1989 effective 1 July 1995. b. Conditions applicable to specific classes of registered therapeutic goods as specified in the Standard Conditions Applying to Registered or Listed Therapeutic Goods under Section 28 of the Therapeutic Goods Act 1989 effective 1 July 1995 | import and supply | Prescription medicines | |
| ULTRAVIST 150 iopromide 62.34 g/200 mL injection bottle | Bayer Australia Ltd | 48503 | CON-1018 | The consent is effective for all batches of the products released for supply from 20 October 2022 until 20 October 2024. | 20/10/2022 | Paragraph 10(2)(f) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The products do not include the statement ‘Use in one patient on one occasion only’, rather the label states ‘For use in a single-use setting or with an automated contrast injection system approved for multi-patient use’. | Import and supply | Prescription medicines | ||
| ULTRAVIST 370 iopromide 153.77 g/200 mL injection bottle | Bayer Australia Ltd | 48501 | CON-1018 | The consent is effective for all batches of the products released for supply from 20 October 2022 until 20 October 2024. | 20/10/2022 | Paragraph 10(2)(f) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The products do not include the statement ‘Use in one patient on one occasion only’, rather the label states ‘For use in a single-use setting or with an automated contrast injection system approved for multi-patient use’. | Import and supply | Prescription medicines | ||
| SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial | Moderna Australia Pty Ltd | 389513 | CON-1017 | The consent is effective from 18 October 2022 until 29 August 2024 | 18/10/2022 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | The product is non-compliant with TGO91 in that the labels are international labels. | 1. The product must be supplied with the labels that were considered and agreed to as part of the evaluation under section 9D(3) of the Therapeutic Goods Act 1989, being the ‘International Labels’, vial and carton labels, for drug product referred to in submission PM-2022-03959-1-2 as follows: > a) Drug product manufactured at Catalent Indiana LLCi. Vial label for the 0.1 > mg/mL suspension for injection vial: > ii. Carton label for the 0.1 mg/mL suspension for injection vial > > > > > b) Drug product manufactured at Rovi Pharma Industrial Services, S.A.i. Vial > label for the 0.1 mg/mL suspension for injection vial ii. Carton label for > the 0.1 mg/mL suspension for injection vial > c) Drug product manufactured at Samsung Biologics Co. Ltd. i. Vial label for > the 0.1 mg/mL suspension for injection vial ii. Carton label for the 0.1 > mg/mL suspension for injection vial | Import and supply | Prescription medicines | |
| TEPMETKO tepotinib 225 mg (as hydrochloride monohydrate) tablet blister pack | Merck Healthcare Pty Ltd | 370977 | CON-1016 | The consent is effective for all relevant batches released from 13 October 2022 until 29 September 2023. | 13/10/2022 | Therapeutic Goods Order No.91 - Standard for labels of prescription and related medicines (TGO 91) | The product is packed in US labelled blister foils. The blisters are packed in US labelled cartons which are overstickered with Australian labels, including the AUST R number. | 1. A Dear Healthcare Professional letter identical to that provided to the Therapeutic Goods Administration on 22 August 2022 will be supplied with each affected batch 2. The Australian PI and CMI documents will be supplied with each affected batch. | Import and supply | Prescription medicines | |
| TIROFIBAN JUNO tirofiban (as hydrochloride) 12.5 mg/50 mL Concentrated Injection for infusion Vial | Juno Pharmaceuticals Pty Ltd | 209216 | HZ201 and HZ202 | CON-1015 | The consent is effective from 13 October 2022 until 30 June 2023. | 13/10/2022 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product is packaged in labels compliant with Therapeutic Goods Order No. 69 (TGO 69). | 1. A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 12 October 2022 will be supplied with each affected batch. 2. The labels to which this consent applies are those previously approved to comply with TGO 69. | Supply | Prescription medicines |
| CILICAINE VK phenoxymethylpenicillin (as potassium) 250 mg capsule blister pack | Viatris Pty Ltd | 339013 | CON-1014 | The consent is effective from 11 October 2022 until 11 October 2023. | 11/10/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product label does not include the name and address of the current sponsor or supplier of the goods. | Import and supply | Prescription medicines | ||
| VIAGRA sildenafil (as citrate) 50 mg tablet blister pack | Viatris Pty Ltd | 64435 | B700003 | CON-1012 | The consent is effective from 30 September 2022 until 30 September 2024 for import and supply of the affected batch. | 30/09/2022 | Paragraph 10(14)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product blister does not include the prefixes for batch number and expiry date. | A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutics Goods Administration on 27 September 2022 will be supplied with each affected batch. | Import and supply | Prescription medicines |
| Sodium iodide(131I) 2000 MBq/mL Therapy Solution oral liquid BP vial | Australian Nuclear Science and Technology Organisation T/A ANSTO | 48267 | CON-1011 | This consent is effective from 26 September 2022 until 31 December 2022. | 26/09/2022 | Therapeutic Goods (Microbiological Standards for Medicines) Order 2018 (TGO 100), subsection 11(1). | The product does not conform with subsection 11(1) of the Therapeutic Goods (Microbiological Standards for Medicines) Order 2018 (TGO 100), as the product(s) do not include required testing criteria for microbiological attributes for a non-sterile medicine. | Supply and export | Prescription medicines | ||
| AUSTRALIAN RADIOISOTOPES Sodium Iodide (I-131) 50 - 6000 MBq Therapy Capsule vial | Australian Nuclear Science and Technology Organisation T/A ANSTO | 22808 | CON-1011 | This consent is effective from 26 September 2022 until 31 December 2022. | 26/09/2022 | Therapeutic Goods (Microbiological Standards for Medicines) Order 2018 (TGO 100), subsection 11(1). | The product does not conform with subsection 11(1) of the Therapeutic Goods (Microbiological Standards for Medicines) Order 2018 (TGO 100), as the product(s) do not include required testing criteria for microbiological attributes for a non-sterile medicine. | Supply and export | Prescription medicines | ||
| Sodium iodide(131I) 200 MBq/mL Therapy Solution oral liquid BP vial | Australian Nuclear Science and Technology Organisation T/A ANSTO | 22807 | CON-1011 | This consent is effective from 26 September 2022 until 31 December 2022. | 26/09/2022 | Therapeutic Goods (Microbiological Standards for Medicines) Order 2018 (TGO 100), subsection 11(1). | The product does not conform with subsection 11(1) of the Therapeutic Goods (Microbiological Standards for Medicines) Order 2018 (TGO 100), as the product(s) do not include required testing criteria for microbiological attributes for a non-sterile medicine. | Supply and export | Prescription medicines | ||
| Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Matrix - Implant - Pouch | Medtronic Australasia Pty Ltd | 229636 | T42200AUS-149 Units T42210AUS-133 Units T42275AUS-68 Units T42280AUS-17 Units | CON-1013 | The consent is effective from 21 September 2022 until 21 December 2022. | 21/09/2022 | clause 11(18) of the Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order. | The products do not conform with clause 11(18) of TGO 108 that specifies that the serum or plasma of a blood sample taken from a donor of HCT materials must be retained for a minimum of two years after the expiry date of the relevant HCT product, or for a period that is validated on the basis of validated data or documented evidence from relevant scientific literature. | Import and supply | Blood, tissues, and biologicals | |
| Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton Plus DBM Paste - Implant - Syringe | Medtronic Australasia Pty Ltd | 229635 | T45001AUS-411 Units T45010AUS-138 Units | CON-1013 | The consent is effective from 21 September 2022 until 21 December 2022. | 21/09/2022 | clause 11(18) of the Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order. | The products do not conform with clause 11(18) of TGO 108 that specifies that the serum or plasma of a blood sample taken from a donor of HCT materials must be retained for a minimum of two years after the expiry date of the relevant HCT product, or for a period that is validated on the basis of validated data or documented evidence from relevant scientific literature. | Import and supply | Blood, tissues, and biologicals | |
| Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Flex - Implant - Pouch | Medtronic Australasia Pty Ltd | 229634 | T42100AUS - 39 Units T42110AUS - 92 Units | CON-1013 | The consent is effective from 21 September 2022 until 21 December 2022. | 21/09/2022 | clause 11(18) of the Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order. | The products do not conform with clause 11(18) of TGO 108 that specifies that the serum or plasma of a blood sample taken from a donor of HCT materials must be retained for a minimum of two years after the expiry date of the relevant HCT product, or for a period that is validated on the basis of validated data or documented evidence from relevant scientific literature. | Import and supply | Blood, tissues, and biologicals | |
| Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Orthoblend - Implant - Jar/Can | Medtronic Australasia Pty Ltd | 229633 | T44125AUS-31 Units T44145AUS-299 Units T44150AUS-279 units | CON-1013 | The consent is effective from 21 September 2022 until 21 December 2022. | 21/09/2022 | clause 11(18) of the Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order. | The products do not conform with clause 11(18) of TGO 108 that specifies that the serum or plasma of a blood sample taken from a donor of HCT materials must be retained for a minimum of two years after the expiry date of the relevant HCT product, or for a period that is validated on the basis of validated data or documented evidence from relevant scientific literature. | Import and supply | Blood, tissues, and biologicals | |
| Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Matrix - Medtronic Australasia Pty Ltd - Implant - Pouch | Medtronic Australasia Pty Ltd | 229636 | T42200AUS - 49 units T42210AUS - 83 units T42275AUS - 67 units T42280AUS -17 units | CON-1010 | The consent is effective from the 21 September 2022 until 21 December 2022. | 21/09/2022 | Clause 11(18) of the Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order. | The products do not conform with clause 11(18) of TGO 108 that specifies that the serum or plasma of a blood sample taken from a donor of HCT materials must be retained for a minimum of two years after the expiry date of the relevant HCT product, or for a period that is validated on the basis of validated data or documented evidence from relevant scientific literature. | Import and supply | Blood, tissues, and biologicals | |
| Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton Plus DBM Paste - Medtronic Australasia Pty Ltd - Implant - Syringe | Medtronic Australasia Pty Ltd | 229635 | T45001AUS - 310 units T45010AUS -123 units | CON-1010 | The consent is effective from the 21 September 2022 until 21 December 2022. | 21/09/2022 | Clause 11(18) of the Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order. | The products do not conform with clause 11(18) of TGO 108 that specifies that the serum or plasma of a blood sample taken from a donor of HCT materials must be retained for a minimum of two years after the expiry date of the relevant HCT product, or for a period that is validated on the basis of validated data or documented evidence from relevant scientific literature. | Import and supply | Blood, tissues, and biologicals | |
| Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Flex - Medtronic Australasia Pty Ltd - Implant - Pouch | Medtronic Australasia Pty Ltd | 229634 | T42100AUS - 17 units T42110AUS - 26 units | CON-1010 | The consent is effective from the 21 September 2022 until 21 December 2022. | 21/09/2022 | Clause 11(18) of the Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order. | The products do not conform with clause 11(18) of TGO 108 that specifies that the serum or plasma of a blood sample taken from a donor of HCT materials must be retained for a minimum of two years after the expiry date of the relevant HCT product, or for a period that is validated on the basis of validated data or documented evidence from relevant scientific literature. | Import and supply | Blood, tissues, and biologicals | |
| Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Orthoblend - Medtronic Australasia Pty Ltd - Implant - Jar/Can | Medtronic Australasia Pty Ltd | 229633 | T44125AUS - 22 units T44145AUS - 242 units T44150AUS - 213 units | CON-1010 | The consent is effective from the 21 September 2022 until 21 December 2022. | 21/09/2022 | Clause 11(18) of the Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order. | The products do not conform with clause 11(18) of TGO 108 that specifies that the serum or plasma of a blood sample taken from a donor of HCT materials must be retained for a minimum of two years after the expiry date of the relevant HCT product, or for a period that is validated on the basis of validated data or documented evidence from relevant scientific literature. | Import and supply | Blood, tissues, and biologicals | |
| PHARMACY ACTION Low Dose Aspirin 100 mg tablet blister pack | Generic Health Pty Ltd | 190572 | D10504A and D11336C | CON-1008 | The consent is effective from 16 September 2022 until the affected batches have been depleted. | 16/09/2022 | paragraphs 9(1)(b), 9(1)(c) and 9(1)(d) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92). | The product does not comply because the carton main labels are missing the name and quantity of the active ingredient ‘Aspirin 100 mg’ and the full name of the dosage form ‘enteric-coated tablets’. | Supply | Over-the-counter medicines | |
| VECTIBIX panitumumab 400 mg/20 mL concentrated injection vial | Amgen Australia Pty Ltd | 128332 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| VECTIBIX panitumumab 100 mg/5 mL concentrated injection vial | Amgen Australia Pty Ltd | 128270 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| PROLIA denosumab (rch) 60 mg/1 mL solution for injection prefilled syringe with automatic needle guard | Amgen Australia Pty Ltd | 159323 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| OTEZLA TITRATION PACK apremilast tablet blister pack | Amgen Australia Pty Ltd | 220424 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| OTEZLA apremilast 30 mg film coated tablet blister pack | Amgen Australia Pty Ltd | 220423 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| NPLATE romiplostim (rbe) 625 microgram powder for injection vial | Amgen Australia Pty Ltd | 147188 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| NPLATE romiplostim (rbe) 375 microgram powder for injection vial | Amgen Australia Pty Ltd | 147187 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| MVASI bevacizumab 400 mg/16 mL injection concentrated vial | Amgen Australia Pty Ltd | 297456 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| MVASI bevacizumab 100 mg/4 mL injection concentrated vial | Amgen Australia Pty Ltd | 297455 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| KYPROLIS carfilzomib 10 mg powder for injection vial | Amgen Australia Pty Ltd | 288527 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| KYPROLIS carfilzomib 60 mg powder for injection vial | Amgen Australia Pty Ltd | 283228 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| KYPROLIS carfilzomib 30 mg powder for injection vial | Amgen Australia Pty Ltd | 266773 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| KANJINTI trastuzumab 420 mg powder for injection vial | Amgen Australia Pty Ltd | 296883 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| KANJINTI trastuzumab 150 mg powder for injection vial | Amgen Australia Pty Ltd | 296881 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| EVENITY romosozumab 105 mg/1.17 mL injection solution syringe | Amgen Australia Pty Ltd | 296831 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| AMGEVITA adalimumab (rch) 20 mg/0.4 mL injection solution syringe | Amgen Australia Pty Ltd | 278702 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| AMGEVITA adalimumab (rch) 40 mg/0.8 mL injection solution syringe | Amgen Australia Pty Ltd | 278701 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| AMGEVITA adalimumab (rch) 40 mg/0.8 mL injection solution syringe within a pen injector | Amgen Australia Pty Ltd | 273536 | CON-1009 | The consent is effective from 13 September 2022 until 01 September 2023. | 13/09/2022 | Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that, on the cartons the contact details of the distributor of the medicine are not current. | Import and supply | Prescription medicines | ||
| XGEVA denosumab (rch) 70 mg/mL (120 mg/1.7 mL) solution for injection vial | Amgen Australia Pty Ltd | 175041 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| RISTEMPA pegfilgrastim (rbe) 6 mg/0.6 mL injection syringe with automatic needle guard | Amgen Australia Pty Ltd | 283847 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| REPATHA evolocumab (rch) 420 mg/3.5 mL injection solution automated mini-doser AMD | Amgen Australia Pty Ltd | 348651 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| REPATHA evolocumab (rch) 140 mg/mL injection solution syringe within a pen injector | Amgen Australia Pty Ltd | 231152 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| NEUPOGEN filgrastim (rbe) 480 microgram/0.5 mL injection syringe | Amgen Australia Pty Ltd | 53581 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| NEUPOGEN filgrastim (rbe) 300 microgram/0.5 mL injection syringe | Amgen Australia Pty Ltd | 53580 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| NEUPOGEN filgrastim (rbe) 300 microgram/1 mL injection vial | Amgen Australia Pty Ltd | 53579 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| NEUPOGEN filgrastim (rbe) 480 microgram/1.6 mL injection vial | Amgen Australia Pty Ltd | 53577 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| BLINCYTO blinatumomab (rch) 38.5 microgram powder for injection vial with Intravenous (IV) solution stabiliser | Amgen Australia Pty Ltd | 232805 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| ARANESP darbepoetin alfa (rch) 60 microgram/0.3 mL injection syringe with automatic needle guard | Amgen Australia Pty Ltd | 166688 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| ARANESP darbepoetin alfa (rch) 80 microgram/0.4 mL injection syringe with automatic needle guard | Amgen Australia Pty Ltd | 166097 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| ARANESP darbepoetin alfa (rch) 50 microgram/0.5 mL injection syringe with automatic needle guard | Amgen Australia Pty Ltd | 166095 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| ARANESP darbepoetin alfa (rch) 40 microgram/0.4 mL injection syringe with automatic needle guard | Amgen Australia Pty Ltd | 166094 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| ARANESP darbepoetin alfa (rch) 30 microgram/0.3 mL injection syringe with automatic needle guard | Amgen Australia Pty Ltd | 166092 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| ARANESP darbepoetin alfa (rch) 20 microgram/0.5 mL injection syringe with automatic needle guard | Amgen Australia Pty Ltd | 166090 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| ARANESP darbepoetin alfa (rch) 150 microgram/0.3 mL injection syringe with automatic needle guard | Amgen Australia Pty Ltd | 166089 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| ARANESP darbepoetin alfa (rch) 100 microgram/0.5 mL injection syringe with automatic needle guard | Amgen Australia Pty Ltd | 166087 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| ARANESP darbepoetin alfa (rch) 80 microgram/0.4 mL injection syringe within a pen injector | Amgen Australia Pty Ltd | 122855 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| ARANESP darbepoetin alfa (rch) 150 microgram/0.3 mL injection syringe within a pen injector | Amgen Australia Pty Ltd | 122854 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| ARANESP darbepoetin alfa (rch) 20 microgram/0.5 mL injection syringe within a pen injector | Amgen Australia Pty Ltd | 122853 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| ARANESP darbepoetin alfa (rch) 100 microgram/0.5 mL injection syringe within a pen injector | Amgen Australia Pty Ltd | 122852 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| ARANESP darbepoetin alfa (rch) 40 microgram/0.4 mL injection syringe within a pen injector | Amgen Australia Pty Ltd | 122851 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| ARANESP darbepoetin alfa (rch) 60 microgram/0.3 mL injection syringe within a pen injector | Amgen Australia Pty Ltd | 122849 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| ARANESP darbepoetin alfa (rch) 10 microgram/0.4 mL injection syringe | Amgen Australia Pty Ltd | 77950 | CON-1007 | The consent is effective for all batches of the products manufactured until 01 March 2024. | 13/09/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The products’ labels do not comply with the TGO 91 in that the contact details of the distributor of the medicine are not current on the cartons. | Import and supply | Prescription medicines | ||
| ADIRAMEDICA IBUPROFEN SUSPENSION 40 mg/mL oral suspension bottle | Adiramedica Pty Ltd | 393798 | CON-1006 | The consent is effective from 8 September 2022 until 8 September 2023 | 8/09/2022 | The products do not comply with the monograph of the British Pharmacopoeia. | The products do not comply because the rotation speed of the dissolution apparatus is 75 rpm as opposed to 50 rpm as specified in the Ibuprofen Oral Suspension monograph of the British Pharmacopoeia. | Import and supply | Over-the-counter medicines | ||
| ADIRAMEDICA IBUPROFEN SUSPENSION 20 mg/mL oral suspension bottle | Adiramedica Pty Ltd | 393797 | CON-1006 | The consent is effective from 8 September 2022 until 8 September 2023 | 8/09/2022 | The products do not comply with the monograph of the British Pharmacopoeia. | The products do not comply because the rotation speed of the dissolution apparatus is 75 rpm as opposed to 50 rpm as specified in the Ibuprofen Oral Suspension monograph of the British Pharmacopoeia. | Import and supply | Over-the-counter medicines | ||
| Key Sun Clear Zinke Mineral SPF50+ | Key-Sun Laboratories Pty Ltd | 376550 | CON-1005 | The consent is effective from 1 September 2022 until 1 October 2026. | 1/09/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Key Sun Clear Zinke Mineral SPF50+ | Key-Sun Laboratories Pty Ltd | 386778 | CON-1005 | The consent is effective from 1 September 2022 until 1 October 2026. | 1/09/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Key Sun Clear Zinke Vegan SPF50 | Key-Sun Laboratories Pty Ltd | 322738 | CON-1000 | The consent is effective from 31 August 2022 until 1 October 2026. | 31/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| KEY SUN ZINKE STICK SPF50+ - PASTEL TEAL | Key-Sun Laboratories Pty Ltd | 292866 | CON-1000 | The consent is effective from 31 August 2022 until 1 October 2026. | 31/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Key Sun Clear Zinke SPF50+ Roll On | Key-Sun Laboratories Pty Ltd | 302167 | CON-1000 | The consent is effective from 31 August 2022 until 1 October 2026. | 31/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Key Sun Zinke Clear SPF50+ Coconut Scented | Key-Sun Laboratories Pty Ltd | 291657 | CON-1000 | The consent is effective from 31 August 2022 until 1 October 2026. | 31/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Key Sun White Zinke SPF50+ Stick | Key-Sun Laboratories Pty Ltd | 286353 | CON-1000 | The consent is effective from 31 August 2022 until 1 October 2026. | 31/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Key Sun Clear Zinke for Babies Toddlers SPF50+ | Key-Sun Laboratories Pty Ltd | 275539 | CON-1000 | The consent is effective from 31 August 2022 until 1 October 2026. | 31/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Key Sun Clear Zinke SPF50+ | Key-Sun Laboratories Pty Ltd | 275540 | CON-1000 | The consent is effective from 31 August 2022 until 1 October 2026. | 31/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Key Sun Blue Zinke Stick SPF50+ | Key-Sun Laboratories Pty Ltd | 285366 | CON-1000 | The consent is effective from 31 August 2022 until 1 October 2026. | 31/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Key Sun Yellow Zinke SPF50+ | Key-Sun Laboratories Pty Ltd | 285365 | CON-1000 | The consent is effective from 31 August 2022 until 1 October 2026. | 31/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Key Sun Pink Zinke Stick SPF50+ | Key-Sun Laboratories Pty Ltd | 285367 | CON-1000 | The consent is effective from 31 August 2022 until 1 October 2026. | 31/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Key Sun Green Zinke Stick SPF50+ | Key-Sun Laboratories Pty Ltd | 285362 | CON-1000 | The consent is effective from 31 August 2022 until 1 October 2026. | 31/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Key Sun Clear Zinke Sensitive Skin SPF50+ | Key-Sun Laboratories Pty Ltd | 285460 | CON-1000 | The consent is effective from 31 August 2022 until 1 October 2026. | 31/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Key Sun Tanne Zinke SPF50+ Stick | Key-Sun Laboratories Pty Ltd | 285835 | CON-1000 | The consent is effective from 31 August 2022 until 1 October 2026. | 31/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Key Sun Red Zinke SPF50+ | Key-Sun Laboratories Pty Ltd | 263652 | CON-1000 | The consent is effective from 31 August 2022 until 1 October 2026. | 31/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Key Sun White Zinke SPF30+ | Key-Sun Laboratories Pty Ltd | 200843 | CON-1000 | The consent is effective from 31 August 2022 until 1 October 2026. | 31/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| KEY SUN TANNE SPORTS ZINKE SPF30+ | Key-Sun Laboratories Pty Ltd | 69560 | CON-1000 | The consent is effective from 31 August 2022 until 1 October 2026. | 31/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| KEYSUN ZINKE STICK PURPLE SPF50+ | Key-Sun Laboratories Pty Ltd | 214873 | CON-1000 | The consent is effective from 31 August 2022 until 1 October 2026. | 31/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| FOSCAVIR foscarnet sodium 6 g/250 mL injection bottle | Link Medical Products Pty Ltd TA Link Pharmaceuticals | 37310 | CON-994 | The consent is effective from the 31 August 2022 until 31 August 2027. | 31/08/2022 | British Pharmacopoeia (BP) supplementary chapter SC IV Q. Elemental Impurities and European Pharmacopoeia (Ph. Eur.) general text 5.20 | The product does not conform with the ICH Q3D limits (as adopted by the BP and Ph. Eur. general chapters) for barium content. | Import and supply | Prescription medicines | ||
| Brauer Ultra Pure DHA for Pregnancy Breastfeeding | BNutrition Pty Ltd | 307113 | CON-1004 | The consent is effective from the 1 September 2022 until 1 October 2026. | 30/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Brauer Baby Kids Ultra Pure DHA | BNutrition Pty Ltd | 307115 | CON-1004 | The consent is effective from the 1 September 2022 until 1 October 2026. | 30/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Brauer Baby Kids Ultra Pure Cod Liver Oil with DHA | BNutrition Pty Ltd | 307114 | CON-1004 | The consent is effective from the 1 September 2022 until 1 October 2026. | 30/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Brauer Baby Kids Liquid Vitamin D 400IU | BNutrition Pty Ltd | 302169 | CON-1004 | The consent is effective from the 1 September 2022 until 1 October 2026. | 30/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Brauer Baby Kids Liquid Calcium with Magnesium and Zinc | BNutrition Pty Ltd | 302979 | CON-1004 | The consent is effective from the 1 September 2022 until 1 October 2026. | 30/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Brauer Kids Liquid Iron with Vitamin B | BNutrition Pty Ltd | 313393 | CON-1004 | The consent is effective from the 1 September 2022 until 1 October 2026. | 30/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Caruso's Mega B Complex | Caruso's Natural Health Pty Ltd | 279840 | CON-999 | The consent is effective from 1 September 2022 until 1 October 2026. | 30/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Caruso's Mega B Complex | Caruso's Natural Health Pty Ltd | 279840 | CON-988 | The consent is effective from 1 September 2022 until 1 October 2026. | 30/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The product does not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| SPIKEVAX (elasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial | Moderna Australia Pty Ltd | 388244 | CON-984 | The consent is effective from 29 August 2022 until 15 July 2024 | 29/08/2022 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | The carton and vial labels are supplied with ‘International Labels’ which do not comply with Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | 1. The product must be supplied with the labels that were considered and agreed to as part of the evaluation under section 9D(3) of the Therapeutic Goods Act 1989, being a) The ‘International Labels’, vial and carton labels, for drug product manufactured at Catalent Indiana LLC, referred to in submission as follows i. Vial label for the 0.1 mg/mL suspension for injection vial ii. Carton label for the 0.1 mg/mL suspension for injection vial | Import and supply | Prescription medicines | |
| Bosisto's Eucalyptus Oil | Felton Grimwade Bosisto's Pty Ltd | 10908 | CON-1003 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Bosisto's Lavender Spray | Felton Grimwade Bosisto's Pty Ltd | 314000 | CON-1003 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Bosisto's Tea Tree Spray | Felton Grimwade Bosisto's Pty Ltd | 315698 | CON-1003 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Bosisto's Eucalyptus Spray | Felton Grimwade Bosisto's Pty Ltd | 349597 | CON-1003 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Clements Iron | Felton Grimwade Bosisto's Pty Ltd | 209320 | CON-1003 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Clements Energy and Focus | Felton Grimwade Bosisto's Pty Ltd | 280109 | CON-1003 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY GARLIC HEART CARE | Amway of Australia | 92128 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY OMEGA 3 COMPLEX | Amway of Australia | 82166 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY COMPLEX FOR HAIR SKIN AND NAILS DIETARY SUPPLEMENT | Amway of Australia | 80537 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY* HERBALS TRIPLE SHIELD* ECHINACEA DIETARYSUPPLEMENT | Amway of Australia | 78752 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY Tri-Iron Folic | Amway of Australia | 234661 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Nutriway Trim Choice Advance | Amway of Australia | 230849 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY Cal Mag D Advanced | Amway of Australia | 206345 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY VITAMIN C PLUS EXTENDED RELEASE | Amway of Australia | 174148 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY GLUCOSAMINE HCL WITH BOSWELLIA DIETARY SUPPLEMENT | Amway of Australia | 154934 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY DAILY MULTIVITAMIN MULTIMINERAL TABLET | Amway of Australia | 152479 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY FIBRE BLEND CHEWABLE TABLET | Amway of Australia | 145941 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY MILK THISTLE AND DANDELION DIETARY SUPPLEMENT | Amway of Australia | 120668 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY CARB BLOCKER PLUS HERBAL DIETARY SUPPLEMENT | Amway of Australia | 114288 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY CHOLESTEROL HEALTH GREEN TEA DIETARY SUPPLEMENT | Amway of Australia | 104714 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY PARSELENIUM-E | Amway of Australia | 77605 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY HERBALS SIBERIAN GINSENG GINKGO BILOBA BLEND HERBAL DIETARY SUPPLEMENT. | Amway of Australia | 59162 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY* Vitamin B Complete Dual Action tablet | Amway of Australia | 268592 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Xs ENERGISE RHODIOLA SUPPLEMENT | Amway of Australia | 266798 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY CONCENTRATED FRUITS AND VEGETABLES | Amway of Australia | 238532 | CON-1001 | The consent is effective from the 26 August 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE LIVER GUARD 35,000 PLUS | Vitaco Health Australia Pty Ltd | 336523 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE BIO-CURCUMIN TURMERIC 16,500+ | Vitaco Health Australia Pty Ltd | 336668 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE COLD FLU IMMUNE SUPPORT | Vitaco Health Australia Pty Ltd | 336589 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE KYOLIC AGED GARLIC EXTRACT HEART CHOLESTEROL FORMULA | Vitaco Health Australia Pty Ltd | 335450 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE GRAPE SEED 50,000 + | Vitaco Health Australia Pty Ltd | 327877 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE GREEN LIPPED MUSSEL 850 MG + | Vitaco Health Australia Pty Ltd | 327201 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE PROBIOTICA DAILY HEALTH | Vitaco Health Australia Pty Ltd | 325284 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE ESTER-C + PROBIOTICS | Vitaco Health Australia Pty Ltd | 324631 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRALIFE MAGNESIUM STRESS EASE | Vitaco Health Australia Pty Ltd | 314025 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE MAGNESIUM HI-ZORB | Vitaco Health Australia Pty Ltd | 314035 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE MAGNESIUM COMPLETE FORTE | Vitaco Health Australia Pty Ltd | 314036 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE PROBIOTICA EXTRA CARE | Vitaco Health Australia Pty Ltd | 311717 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE SUPER B PLUS | Vitaco Health Australia Pty Ltd | 311315 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE BILBERRY 10,000 PLUS | Vitaco Health Australia Pty Ltd | 310442 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE PROSTATE COMPLETE | Vitaco Health Australia Pty Ltd | 308311 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE PROBIOTICA KID'S DAILY | Vitaco Health Australia Pty Ltd | 300534 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE SILICAPLEX 5000 | Vitaco Health Australia Pty Ltd | 289118 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE COQ10 300 MG | Vitaco Health Australia Pty Ltd | 286704 | CON-998 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE MAGNESIUM SLEEP | Vitaco Health Australia Pty Ltd | 284655 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE ESTER-C + BIOFLAVONOIDS | Vitaco Health Australia Pty Ltd | 284792 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE JOINT FORMULA + MSM UNFLAVOURED POWDER | Vitaco Health Australia Pty Ltd | 284718 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE JOINT FORMULA + MSM CONCENTRATE POWDER | Vitaco Health Australia Pty Ltd | 284712 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE SUPER CALCIUM COMPLETE | Vitaco Health Australia Pty Ltd | 284646 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE JOINT FORMULA + MSM POWDER | Vitaco Health Australia Pty Ltd | 284262 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE ESTER-C + CHEWABLES | Vitaco Health Australia Pty Ltd | 283066 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE OMEGA 3 TRIPLE STRENGTH | Vitaco Health Australia Pty Ltd | 268855 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE DIGESTIVE ENZYMES | Vitaco Health Australia Pty Ltd | 247076 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE CELERY 10,000 | Vitaco Health Australia Pty Ltd | 235360 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE GINKGO 7500 PLUS | Vitaco Health Australia Pty Ltd | 225999 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE ESTER-C HIGH STRENGTH + BIOFLAVONOIDS | Vitaco Health Australia Pty Ltd | 219050 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE ESTER-C POWDER | Vitaco Health Australia Pty Ltd | 219048 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE GLUCOSAMINE 1500 COMPLEX ADVANCED | Vitaco Health Australia Pty Ltd | 184317 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE FISH OIL 1500 MG PLUS VITAMIN D | Vitaco Health Australia Pty Ltd | 180397 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE FISH OIL 1000 MG | Vitaco Health Australia Pty Ltd | 149891 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE TRIPLE STRENGTH GARLIC + C, HORSERADISH + | Vitaco Health Australia Pty Ltd | 134591 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE CO-Q-MAX 150 MG | Vitaco Health Australia Pty Ltd | 96692 | CON-997 | The consent is effective from 26 August 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92. | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Colostrum 820 MAX | Homart Pharmaceuticals Pty Ltd | 115093 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| SHARK CARTILAGE 750 mg | Homart Pharmaceuticals Pty Ltd | 90987 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Colostrum Powder 400g | Homart Pharmaceuticals Pty Ltd | 310600 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Evening Primrose Oil 1000 Max | Homart Pharmaceuticals Pty Ltd | 110300 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Propolis Capsule 1000 mg | Homart Pharmaceuticals Pty Ltd | 158240 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Bio-Collagen 4-in-1 Max | Homart Pharmaceuticals Pty Ltd | 1535353 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Premium Propolis Capsule 2000 mg Max | Homart Pharmaceuticals Pty Ltd | 153534 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life NAD+ MAX | Homart Pharmaceuticals Pty Ltd | 168238 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Squalene 1000 Max | Homart Pharmaceuticals Pty Ltd | 110253 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life NAD+ MAX | Homart Pharmaceuticals Pty Ltd | 330661 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life IMMUNI C 1600 MAX | Homart Pharmaceuticals Pty Ltd | 334955 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Propolis Liquid 40% Max | Homart Pharmaceuticals Pty Ltd | 101655 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Kids Vital Calcium 200Max | Homart Pharmaceuticals Pty Ltd | 195686 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Kids Fish Oil 750 Max | Homart Pharmaceuticals Pty Ltd | 164018 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Liver Guard 15000Max | Homart Pharmaceuticals Pty Ltd | 164167 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Omega-3 1000 mg Max | Homart Pharmaceuticals Pty Ltd | 17218 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Premium Cranberry 65000 Max | Homart Pharmaceuticals Pty Ltd | 153474 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Premium Cranberry 65000 Max | Homart Pharmaceuticals Pty Ltd | 24392 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Squalene 1000 Max Complex | Homart Pharmaceuticals Pty Ltd | 153647 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Royal Jelly 1000Max 2.2% HDA | Homart Pharmaceuticals Pty Ltd | 193315 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Royal Jelly 1000Max 2.2% HDA | Homart Pharmaceuticals Pty Ltd | 193312 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Grape Seed 24000 MAX | Homart Pharmaceuticals Pty Ltd | 167661 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Top Life Bilberry 5000Max | Homart Pharmaceuticals Pty Ltd | 173715 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Spring Leaf Kids Mega Milky Calcium | Homart Pharmaceuticals Pty Ltd | 195741 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Propolis Capsule 2000 mg | Homart Pharmaceuticals Pty Ltd | 121926 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Spring Leaf Lecithin 1200 mg | Homart Pharmaceuticals Pty Ltd | 119055 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Spring Leaf Immuni-C Powder 1000 | Homart Pharmaceuticals Pty Ltd | 332585 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Spring Leaf Vitamin C 1000 mg Complex Chewable | Homart Pharmaceuticals Pty Ltd | 334957 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Spring Leaf DHA Algal Oil Drops | Homart Pharmaceuticals Pty Ltd | 336522 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Spring Leaf Shark Cartilage 750 mg | Homart Pharmaceuticals Pty Ltd | 110296 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Spring Leaf Propolis Capsule 500mg | Homart Pharmaceuticals Pty Ltd | 104256 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| SQUALENE 1000 mg | Homart Pharmaceuticals Pty Ltd | 90831 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Spring Leaf Ginkgo Biloba 2000 mg | Homart Pharmaceuticals Pty Ltd | 110297 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Garlic Oil 3000 | Homart Pharmaceuticals Pty Ltd | 127630 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Super Omega 3:6:9 | Homart Pharmaceuticals Pty Ltd | 127631 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Spring Leaf Propolis Capsule 1000 mg | Homart Pharmaceuticals Pty Ltd | 158394 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Spring Leaf Wild Red Krill Oil Complex 700 mg | Homart Pharmaceuticals Pty Ltd | 217085 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Spring Leaf Super Sleep Stress Aid | Homart Pharmaceuticals Pty Ltd | 232959 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Spring Leaf Super Vitamin D 1000 One-A-Day | Homart Pharmaceuticals Pty Ltd | 232489 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Bilberry 5000 | Homart Pharmaceuticals Pty Ltd | 129133 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Spring Leaf NZ Green Lipped Mussel Essence 2000 mg | Homart Pharmaceuticals Pty Ltd | 148896 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Health Nature Squalene 1000 Max | Homart Pharmaceuticals Pty Ltd | 110250 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Health Nature Omega-3 1000 Max | Homart Pharmaceuticals Pty Ltd | 110248 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Health N Nature Premium Propolis Capsule 2000 mg | Homart Pharmaceuticals Pty Ltd | 152940 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Health N Nature Joint 1500 Glucosamine with Chondroitin | Homart Pharmaceuticals Pty Ltd | 152673 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Health N Nature Liver Tonic Active 15000 | Homart Pharmaceuticals Pty Ltd | 164166 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Health Nature Lecithin 1000 mg | Homart Pharmaceuticals Pty Ltd | 121657 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Propolis Capsule 1000 mg | Homart Pharmaceuticals Pty Ltd | 128602 | CON-996 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 | The names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Ultra Magnesium Complete Powder | NutriVital Pty Ltd | 190375 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Premium Glucosamine 1500 Plus | NutriVital Pty Ltd | 230207 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Zinc Complete Tablets | NutriVital Pty Ltd | 287917 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Vitex 1000 One A Day | NutriVital Pty Ltd | 283373 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Vitamin D3 in Rice Bran Oil | NutriVital Pty Ltd | 232417 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Vitamin C and Hesperidin Powder | NutriVital Pty Ltd | 187105 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Vegan BioCurcumin Plus | NutriVital Pty Ltd | 305951 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Triple Strength Omega 3 Concentrate | NutriVital Pty Ltd | 226200 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital St Johns Wort 4000 One A Day | NutriVital Pty Ltd | 283369 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Sleep Formula | NutriVital Pty Ltd | 307510 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Selenium Forte 150 | NutriVital Pty Ltd | 316263 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Premium Women's Multi Tablets | NutriVital Pty Ltd | 192269 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Premium Magnesium Complete | NutriVital Pty Ltd | 227459 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Premium Liver Support | NutriVital Pty Ltd | 232416 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Premium Everyday Multi | NutriVital Pty Ltd | 171345 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Premium Calcium Complete Tablets | NutriVital Pty Ltd | 203047 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Premium 50 Billion Probiotic + | NutriVital Pty Ltd | 281598 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Olive Leaf 6,000 One-a-Day | NutriVital Pty Ltd | 280800 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Odourless Fish Oil 1000 mg | NutriVital Pty Ltd | 201243 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Milk Thistle 35,000 One A Day | NutriVital Pty Ltd | 285192 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Methyl B12 2500 mcg | NutriVital Pty Ltd | 279823 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Magnesium Cramp Bark | NutriVital Pty Ltd | 318346 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Iron 24 mg | NutriVital Pty Ltd | 157355 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Immune Support | NutriVital Pty Ltd | 212125 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Co-Enzyme Q10 150 mg | NutriVital Pty Ltd | 197139 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Activated Charcoal Plus | NutriVital Pty Ltd | 323692 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Non - Acidic Vitamin C Complete | NutriVital Pty Ltd | 261475 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Ultra SB 5 billion + | NutriVital Pty Ltd | 281545 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NutriVital Premium Magnesium Complete | NutriVital Pty Ltd | 227459 | CON-995 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Vitanox | Integria Healthcare Australia Pty Ltd | 336190 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb Vitamin D Spray | Integria Healthcare Australia Pty Ltd | 322174 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Ubiquinol Forte 150 mg | Integria Healthcare Australia Pty Ltd | 220957 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb Neurosom | Integria Healthcare Australia Pty Ltd | 319648 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb MediMag Cognition | Integria Healthcare Australia Pty Ltd | 330246 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb HiPep | Integria Healthcare Australia Pty Ltd | 332793 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Echinacea Premium Tablets | Integria Healthcare Australia Pty Ltd | 331437 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb DiGest Forte | Integria Healthcare Australia Pty Ltd | 259812 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb HiPep | Integria Healthcare Australia Pty Ltd | 332793 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb Omega 3 Clean Essentials | Integria Healthcare Australia Pty Ltd | 317128 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb Phellodendron Forte | Integria Healthcare Australia Pty Ltd | 312261 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Mushroom Forte Liquid | Integria Healthcare Australia Pty Ltd | 301610 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Mushroom Forte | Integria Healthcare Australia Pty Ltd | 301609 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Metabol Complex | Integria Healthcare Australia Pty Ltd | 300236 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb PhytoRegenex Tablets | Integria Healthcare Australia Pty Ltd | 295977 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Methyl Factors tablets | Integria Healthcare Australia Pty Ltd | 294928 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb Joint Defence | Integria Healthcare Australia Pty Ltd | 292905 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Livton Complex | Integria Healthcare Australia Pty Ltd | 292705 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb MediMag Calm | Integria Healthcare Australia Pty Ltd | 288875 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb MediMag Powder | Integria Healthcare Australia Pty Ltd | 288868 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Myrrh Forte | Integria Healthcare Australia Pty Ltd | 287101 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb Poly-C Powder | Integria Healthcare Australia Pty Ltd | 253192 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Hawthorn | Integria Healthcare Australia Pty Ltd | 227142 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb P2-Detox | Integria Healthcare Australia Pty Ltd | 218993 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Horsechestnut Complex | Integria Healthcare Australia Pty Ltd | 214424 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb Nervagesic | Integria Healthcare Australia Pty Ltd | 210977 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb Gymnema | Integria Healthcare Australia Pty Ltd | 204363 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Mexican Valerian (NE) | Integria Healthcare Australia Pty Ltd | 128605 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb PCO Support | Integria Healthcare Australia Pty Ltd | 292833 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb MediMag tablets | Integria Healthcare Australia Pty Ltd | 288714 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Cascara Complex | Integria Healthcare Australia Pty Ltd | 290970 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Fe-Max Iron Tonic | Integria Healthcare Australia Pty Ltd | 297027 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb Fe-Max Tablet | Integria Healthcare Australia Pty Ltd | 299646 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb Curcuma Active | Integria Healthcare Australia Pty Ltd | 315129 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb Garlic Forte | Integria Healthcare Australia Pty Ltd | 329108 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb Evening Primrose Oil 1g stand | Integria Healthcare Australia Pty Ltd | 51894 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Chaste Tree | Integria Healthcare Australia Pty Ltd | 76384 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Clivers Complex | Integria Healthcare Australia Pty Ltd | 76393 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Broncafect | Integria Healthcare Australia Pty Ltd | 142087 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Adrenal Complex | Integria Healthcare Australia Pty Ltd | 168180 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Ginkgo Forte | Integria Healthcare Australia Pty Ltd | 197966 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb EFA Essentials | Integria Healthcare Australia Pty Ltd | 225464 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb Andrographis Complex | Integria Healthcare Australia Pty Ltd | 227817 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb EndoFem | Integria Healthcare Australia Pty Ltd | 237217 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb FibroFem | Integria Healthcare Australia Pty Ltd | 237222 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Cramplex | Integria Healthcare Australia Pty Ltd | 282383 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb GIT Regenex | Integria Healthcare Australia Pty Ltd | 284828 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb Tissue Regenex | Integria Healthcare Australia Pty Ltd | 329896 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb Pulmaco | Integria Healthcare Australia Pty Ltd | 325368 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb ProstaCo | Integria Healthcare Australia Pty Ltd | 316653 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Mediherb Rhodiola Ginseng | Integria Healthcare Australia Pty Ltd | 315874 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Silymarin | Integria Healthcare Australia Pty Ltd | 293910 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Ubiquinol Forte 300 | Integria Healthcare Australia Pty Ltd | 290747 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Stealth Complex | Integria Healthcare Australia Pty Ltd | 286616 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Zinc-C Powder | Integria Healthcare Australia Pty Ltd | 285687 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb PolyFem | Integria Healthcare Australia Pty Ltd | 237218 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb ThyAdren Support | Integria Healthcare Australia Pty Ltd | 231018 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Valerian Complex | Integria Healthcare Australia Pty Ltd | 226203 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb ResCo | Integria Healthcare Australia Pty Ltd | 201349 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Sheep Sorrel Combination NE | Integria Healthcare Australia Pty Ltd | 137428 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Slippery Elm 400 mg | Integria Healthcare Australia Pty Ltd | 107217 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| MediHerb Wormwood Complex | Integria Healthcare Australia Pty Ltd | 91797 | CON-993 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's One-A-Day Ginkgo 6000 | Integria Healthcare Australia Pty Ltd | 283710 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's One-A-Day Echinacea 4000 | Integria Healthcare Australia Pty Ltd | 306994 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's One-A-Day Celery 5000 capsules | Integria Healthcare Australia Pty Ltd | 290741 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's One-A-Day Ultra Cranberry 60000 | Integria Healthcare Australia Pty Ltd | 316097 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's One-A-Day AstaMax | Integria Healthcare Australia Pty Ltd | 221922 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Natural E 500IU | Integria Healthcare Australia Pty Ltd | 310896 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Multivital liquid | Integria Healthcare Australia Pty Ltd | 327455 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Men's Multi Tablets | Integria Healthcare Australia Pty Ltd | 324964 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Maca 1000 | Integria Healthcare Australia Pty Ltd | 279219 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Ultra Liver Detox Liquid | Integria Healthcare Australia Pty Ltd | 323921 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Liver Cleanse | Integria Healthcare Australia Pty Ltd | 292762 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Immunofort | Integria Healthcare Australia Pty Ltd | 341874 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Glucosamine Chondroitin with Boron | Integria Healthcare Australia Pty Ltd | 276818 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Garlic Perles | Integria Healthcare Australia Pty Ltd | 288866 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| THOMPSON'S FAT BLOCKER CAPSULES | Integria Healthcare Australia Pty Ltd | 288572 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Biotin 150 mcg | Integria Healthcare Australia Pty Ltd | 261294 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's B Complex | Integria Healthcare Australia Pty Ltd | 264390 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Ashwagandha Complex NIGHT | Integria Healthcare Australia Pty Ltd | 328820 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Ashwagandha Complex DAY | Integria Healthcare Australia Pty Ltd | 329000 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Astraforte tablet | Integria Healthcare Australia Pty Ltd | 222750 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's AstraForte Oral Liquid | Integria Healthcare Australia Pty Ltd | 217887 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Vitamin D3 1000IU | Integria Healthcare Australia Pty Ltd | 179619 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Vitamin C 1000 | Integria Healthcare Australia Pty Ltd | 320774 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| THOMPSON'S VITAMIN A 10000IU | Integria Healthcare Australia Pty Ltd | 283706 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Ultra Strength Resveratrol | Integria Healthcare Australia Pty Ltd | 326733 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Ultra Liver Detox Liquid | Integria Healthcare Australia Pty Ltd | 323921 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Ultra Grape Seed 50000 | Integria Healthcare Australia Pty Ltd | 273767 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Ultra Cranberry 50000 Liquid | Integria Healthcare Australia Pty Ltd | 273823 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's High Strength Ultra CoQ10 300 | Integria Healthcare Australia Pty Ltd | 288877 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Ultra CoQ10 | Integria Healthcare Australia Pty Ltd | 159961 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Ultra C 1000, Tablets | Integria Healthcare Australia Pty Ltd | 319030 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Ultra B12 1000 mcg | Integria Healthcare Australia Pty Ltd | 297677 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Turmeric Joint Support | Integria Healthcare Australia Pty Ltd | 251793 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Triplex Oral liquid | Integria Healthcare Australia Pty Ltd | 225217 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Slippery Elm Bark Tablets | Integria Healthcare Australia Pty Ltd | 323773 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Skin, Hair Nails | Integria Healthcare Australia Pty Ltd | 333379 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Salmon Oil Plus 1000 mg Capsules | Integria Healthcare Australia Pty Ltd | 158900 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Prostate Support | Integria Healthcare Australia Pty Ltd | 287538 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Phytosterol Complex | Integria Healthcare Australia Pty Ltd | 291022 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| THOMPSON'S ORGANIC ZINC TABLETS | Integria Healthcare Australia Pty Ltd | 68145 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Organic Selenium 150 | Integria Healthcare Australia Pty Ltd | 261404 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Organic Magnesium | Integria Healthcare Australia Pty Ltd | 272334 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Organic Iron | Integria Healthcare Australia Pty Ltd | 266925 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's One-A-Day Valerian 2000 | Integria Healthcare Australia Pty Ltd | 287407 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's One-A-Day Ultra Cranberry 60000 | Integria Healthcare Australia Pty Ltd | 316097 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's One-A-Day Tribulus 20000 | Integria Healthcare Australia Pty Ltd | 289113 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's One-A-Day St John's Wort 4000 | Integria Healthcare Australia Pty Ltd | 238192 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's One-A-Day Organic Olive Leaf 5000 | Integria Healthcare Australia Pty Ltd | 302686 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's One-A-Day Milk Thistle 42000 | Integria Healthcare Australia Pty Ltd | 291537 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's One-A-Day Kava 3800 | Integria Healthcare Australia Pty Ltd | 285751 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's One-A-Day Hawthorn 2000 | Integria Healthcare Australia Pty Ltd | 287074 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's One-A-Day Grape Seed 19000 | Integria Healthcare Australia Pty Ltd | 322270 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Manuka Sore Throat Spray | Integria Healthcare Australia Pty Ltd | 297382 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Omega 3 Fish Oil Capsules | Integria Healthcare Australia Pty Ltd | 321099 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's One-A-Day Bilberry 12000 | Integria Healthcare Australia Pty Ltd | 281324 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's One-A-Day Vitex 1500 | Integria Healthcare Australia Pty Ltd | 274356 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thompson's Salmon Oil Plus 1000 mg Capsules | Integria Healthcare Australia Pty Ltd | 158900 | CON-992 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thursday Plantation Tea Tree Manuka Honey Healing Balm | Integria Healthcare Australia Pty Ltd | 295668 | CON-991 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thursday Plantation Tea Tree Anti-Fungal Solution for Nails | Integria Healthcare Australia Pty Ltd | 259986 | CON-991 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thursday Plantation Tea Tree Spray | Integria Healthcare Australia Pty Ltd | 165994 | CON-991 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thursday Plantation Tea Tree Antiseptic Ointment | Integria Healthcare Australia Pty Ltd | 211663 | CON-991 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thursday Plantation Tea Tree Antiseptic Cream | Integria Healthcare Australia Pty Ltd | 167903 | CON-991 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thursday Plantation Tea Tree Antiseptic Spray with Aloe Vera | Integria Healthcare Australia Pty Ltd | 166190 | CON-991 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| THURSDAY PLANTATION TEA TREE HEAD LICE GEL | Integria Healthcare Australia Pty Ltd | 81593 | CON-991 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| THURSDAY PLANTATION TEA TREE ANTI-FUNGAL GEL | Integria Healthcare Australia Pty Ltd | 74586 | CON-991 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| THURSDAY PLANTATION TEA TREE MEDICATED GEL FOR ACNE | Integria Healthcare Australia Pty Ltd | 55740 | CON-991 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thursday Plantation Tea Tree Antiseptic Liquid | Integria Healthcare Australia Pty Ltd | 350297 | CON-991 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| THURSDAY PLANTATION TEA TREE COLD SORE cream tube | Integria Healthcare Australia Pty Ltd | 50564 | CON-991 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| THURSDAY PLANTATION TEA TREE OIL Melaleuca Oil 1 mL/mL multipurpose liquid bottle | Integria Healthcare Australia Pty Ltd | 15674 | CON-991 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| EAGLE VITAMIN D3 1000IU CAPSULES | Integria Healthcare Australia Pty Ltd | 152564 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Vitamin D3 1000IU Spray | Integria Healthcare Australia Pty Ltd | 322175 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Ubiquinol Bio Q10 150 | Integria Healthcare Australia Pty Ltd | 215562 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Ubiquinol Bio Q10 300 | Integria Healthcare Australia Pty Ltd | 290745 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Tresos Natal | Integria Healthcare Australia Pty Ltd | 315610 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Tresos Energy | Integria Healthcare Australia Pty Ltd | 276094 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Tresos Activated B PluSe | Integria Healthcare Australia Pty Ltd | 322566 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Tissue Matrix Support | Integria Healthcare Australia Pty Ltd | 326305 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Sublingual B12 1000 | Integria Healthcare Australia Pty Ltd | 297676 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Seleno Forte 150 | Integria Healthcare Australia Pty Ltd | 261405 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Q10 150 Capsules | Integria Healthcare Australia Pty Ltd | 158295 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Omega Vital Pure Omega-3 Concentrate | Integria Healthcare Australia Pty Ltd | 204123 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle DHA + Choline | Integria Healthcare Australia Pty Ltd | 275316 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| EAGLE NATURAL VITAMIN E 500IU WATER DISPERSIBLE CAPSULES | Integria Healthcare Australia Pty Ltd | 73328 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Nutra-Mag BioMuscle Powder | Integria Healthcare Australia Pty Ltd | 262976 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle MAG Restore Tablets | Integria Healthcare Australia Pty Ltd | 308247 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| EAGLE MAG-ORO TABLETS | Integria Healthcare Australia Pty Ltd | 289775 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Lavandula Calm | Integria Healthcare Australia Pty Ltd | 311525 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Haemo-Red Plus | Integria Healthcare Australia Pty Ltd | 292911 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle CytoPro Repair | Integria Healthcare Australia Pty Ltd | 229911 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Curcuvestin Complex | Integria Healthcare Australia Pty Ltd | 315374 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Cat's Claw - Echine | Integria Healthcare Australia Pty Ltd | 324889 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Beta A-C Tablets | Integria Healthcare Australia Pty Ltd | 295851 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Adreno Restore Plus Tablets | Integria Healthcare Australia Pty Ltd | 288713 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Vegie Digestaid | Integria Healthcare Australia Pty Ltd | 330721 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle PathoClear Tablets | Integria Healthcare Australia Pty Ltd | 330532 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle NeuroMood | Integria Healthcare Australia Pty Ltd | 337391 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle GlucoSupport | Integria Healthcare Australia Pty Ltd | 334940 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Elderberry Viral Protect | Integria Healthcare Australia Pty Ltd | 332699 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle Defence Support Tablets | Integria Healthcare Australia Pty Ltd | 334708 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle CytoPro Balance Probiotic Powder | Integria Healthcare Australia Pty Ltd | 220743 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Eagle ACU-Mind | Integria Healthcare Australia Pty Ltd | 333906 | CON-990 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| ENDURA MAX MAGNESIUM RASPBERRY | Metagenics (Aust) Pty Ltd | 324311 | CON-989 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| ENDURA MAX MAGNESIUM CITRUS | Metagenics (Aust) Pty Ltd | 324310 | CON-989 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| ENDURA LOW CARB HYDRATION COCONUT | Metagenics (Aust) Pty Ltd | 330951 | CON-989 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| ENDURA LOW CARB HYDRATION GRAPEBERRY | Metagenics (Aust) Pty Ltd | 330953 | CON-989 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| ENDURA LOW CARB HYDRATION TROPICAL PUNCH | Metagenics (Aust) Pty Ltd | 330952 | CON-989 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| ENDURA LOW CARB HYDRATION LEMON LIME | Metagenics (Aust) Pty Ltd | 330950 | CON-989 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| ENDURA PERFORMANCE HYDRATION LEMON LIME | Metagenics (Aust) Pty Ltd | 330954 | CON-989 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| ENDURA PERFORMANCE HYDRATION ORANGE | Metagenics (Aust) Pty Ltd | 331109 | CON-989 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| ENDURA PERFORMANCE HYDRATION RASPBERRY | Metagenics (Aust) Pty Ltd | 331105 | CON-989 | The consent is effective from 1 September 2022 until 1 October 2026. | 26/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Natural Life Propolis Manuka Spray | Lifetime Health Products Pty Ltd | 319950 | CON-983 | The consent is effective from 1 September 2022 until 1 October 2026. | 25/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Natural Life Propolis Liquid double strength | Lifetime Health Products Pty Ltd | 75196 | CON-983 | The consent is effective from 1 September 2022 until 1 October 2026. | 25/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Natural Life Omega 3 1000 mg | Lifetime Health Products Pty Ltd | 220785 | CON-983 | The consent is effective from 1 September 2022 until 1 October 2026. | 25/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Natural Life Propolis 2000 | Lifetime Health Products Pty Ltd | 197220 | CON-983 | The consent is effective from 1 September 2022 until 1 October 2026. | 25/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Natural Life Royal Jelly 1000 mg | Lifetime Health Products Pty Ltd | 122592 | CON-983 | The consent is effective from 1 September 2022 until 1 October 2026. | 25/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Natural Life Squalene 1000 mg | Lifetime Health Products Pty Ltd | 94402 | CON-983 | The consent is effective from 1 September 2022 until 1 October 2026. | 25/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Natural life Propolis 1000 | Lifetime Health Products Pty Ltd | 224834 | CON-983 | The consent is effective from 1 September 2022 until 1 October 2026. | 25/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Natural Life Lecithin 1200 mg | Lifetime Health Products Pty Ltd | 221428 | CON-983 | The consent is effective from 1 September 2022 until 1 October 2026. | 25/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Natural Life Green Lipped Mussel Plus | Lifetime Health Products Pty Ltd | 319943 | CON-983 | The consent is effective from 1 September 2022 until 1 October 2026. | 25/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Natural Life Propolis 500 | Lifetime Health Products Pty Ltd | 320235 | CON-983 | The consent is effective from 1 September 2022 until 1 October 2026. | 25/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Ddrops Booster | Tycoon Asia Pacific (Australia) Pty Limited | 344046 | CON-982 | The consent is effective from 1 September 2022 until 1 October 2026. | 25/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Ddrops 1000IU | Tycoon Asia Pacific (Australia) Pty Limited | 344045 | CON-982 | The consent is effective from 1 September 2022 until 1 October 2026. | 25/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Baby Ddrops | Tycoon Asia Pacific (Australia) Pty Limited | 344044 | CON-982 | The consent is effective from 1 September 2022 until 1 October 2026. | 25/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NITYR nitisinone 5 mg tablet bottle | Orpharma Pty Ltd | 288128 | CON-981 | The consent is effective from the 25 August 2022 until 31 December 2026. | 25/08/2022 | Subsection 11(5), subsection 8(2) and paragraphs 8(1)(n) and 8(1)(j) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product labels do not include storage conditions in the required format, a machine-readable code in the required format, space for a dispensing label, and do not declare the presence of lactose and sugars. | 1. The labels to which this consent applies are those provided with the letter of application and are overstickered with the warning statements “Prescription Only Medicine” and “Keep Out of Reach of Children”, the Australian sponsor’s details and the AUST R numbers as indicated. 2. A ‘Dear Healthcare Professional’ letter as provided to the Therapeutic Goods Administration dated 18 August 2022 must be provided with each of the affected batches. 3. A copy of the Australian approved Product Information document will accompany each ‘Dear Healthcare Professional’ letter. | Import, supply and export | Prescription medicines | |
| NITYR nitisinone 2 mg tablet bottle | Orpharma Pty Ltd | 288127 | CON-981 | The consent is effective from the 25 August 2022 until 31 December 2026. | 25/08/2022 | Subsection 11(5), subsection 8(2) and paragraphs 8(1)(n) and 8(1)(j) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product labels do not include storage conditions in the required format, a machine-readable code in the required format, space for a dispensing label, and do not declare the presence of lactose and sugars. | 1. The labels to which this consent applies are those provided with the letter of application and are overstickered with the warning statements “Prescription Only Medicine” and “Keep Out of Reach of Children”, the Australian sponsor’s details and the AUST R numbers as indicated. 2. A ‘Dear Healthcare Professional’ letter as provided to the Therapeutic Goods Administration dated 18 August 2022 must be provided with each of the affected batches. 3. A copy of the Australian approved Product Information document will accompany each ‘Dear Healthcare Professional’ letter. | Import, supply and export | Prescription medicines | |
| NITYR nitisinone 10 mg tablet bottle | Orpharma Pty Ltd | 288126 | CON-981 | The consent is effective from the 25 August 2022 until 31 December 2026. | 25/08/2022 | Subsection 11(5), subsection 8(2) and paragraphs 8(1)(n) and 8(1)(j) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product labels do not include storage conditions in the required format, a machine-readable code in the required format, space for a dispensing label, and do not declare the presence of lactose and sugars. | 1. The labels to which this consent applies are those provided with the letter of application and are overstickered with the warning statements “Prescription Only Medicine” and “Keep Out of Reach of Children”, the Australian sponsor’s details and the AUST R numbers as indicated. 2. A ‘Dear Healthcare Professional’ letter as provided to the Therapeutic Goods Administration dated 18 August 2022 must be provided with each of the affected batches. 3. A copy of the Australian approved Product Information document will accompany each ‘Dear Healthcare Professional’ letter. | Import, supply and export | Prescription medicines | |
| Cenovis Fish Oil 1500 mg | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 267172 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Iron Plus | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 265482 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Men's Multi | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 196028 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Women's Multi | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 318459 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Women's Multi + Energy Boost | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 322957 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Men's Multi + Performance | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 322406 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Hair, Skin Nails | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 314234 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Cranberry 30,000 | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 257233 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Echinacea 5000 | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 248433 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Turmeric 3100 | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 237253 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Zinc Plus | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 236895 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Cold Sore Complex | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 235512 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis 50+ Multi | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 233483 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Ginkgo Biloba 2000 | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 226980 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis B Complex | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 159721 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Co-Enzyme Q10 150 mg | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 223677 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Liver Support Milk Thistle 7000 | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 217877 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Guarana + Ginseng | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 217485 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Garlic | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 211990 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Folic Acid 500 mcg | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 90869 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Vitamin C 250 mg | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 53666 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Magnesium | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 154312 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Mega E 500IU | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 167100 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis St John’s Wort | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 128698 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Vitamin D3 1000IU | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 172889 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Celery 2500 | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 245172 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Mega Calcium Plus D | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 167654 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Garlic and Horseradish + C Complex | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 242498 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Multivitamin and Minerals | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 172259 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Easy Sleep Valerian | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 214036 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Echinacea, Garlic, Zinc C | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 147655 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| CENOVIS MEGA B | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 113019 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Sugarless C 500 mg | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 55033 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Mega C 1000 mg | Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare | 67549 | CON-980 | The consent is effective from 1 September 2022 until 1 October 2026. | 23/08/2022 | subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines: | The products do not comply because the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| STAQUIS crisaborole 2% w/w ointment tube | Pfizer Australia Pty Ltd | 295283 | CON-979 | The consent only applies to the 2.5g pack size, and is effective from the 18 August 2022 until 18 August 2023. | 18/08/2022 | Paragraphs 10(12)(d) and 10(12)(e) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The 2.5g pack size of the product(s) tube label does not include batch and expiry prefixes before the batch number and expiry date. | Supply | Prescription medicines | ||
| TRACRIUM atracurium besilate 25 mg/2.5 mL injection ampoule | Aspen Pharmacare Australia Pty Ltd | 11008 | XF419 | CON-978 | The consent is effective from 17 August 2022 until 28 February 2023. | 17/08/2022 | Paragraph 8(1)(g) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The expiry date printed on product labels does not align with the current registered shelf life. | A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 16 August 2022 will be supplied with the affected batch. | Supply | Prescription medicines |
| Hydroxy Thermo Fuel | Bio Health Pharmaceuticals Pty Ltd | 328052 | 6005 | CON-985 | The consent is effective from 11 August 2022 until 11 August 2024. | 11/08/2022 | Therapeutic Goods Order No. 101 - Standard for Tablets, Capsules and Pills (TGO 101) Order 2019 | The product does not comply because the estimated average content of Chromium is 78.8 % of the label claim. As a result, this is outside the lower limit of TGO101 Schedule 2 requirements for a listed product of 90.0 - 160.0 %. | The content of Chromium must be no less than 78.8 % and no more than 160 % of the stated content on the label for the affected batch/es. | Supply | Listed complementary medicines |
| C-Max | Biomedica Nutraceuticals Pty Ltd | 315373 | 37466B | CON-986 | The consent is effective from 5 May 2022 until the stated batch/es are exhausted or 5 May 2024. | 5/08/2022 | Therapeutic Goods Order No. 101 - Standard for Tablets, Capsules and Pills (TGO 101) Order 2019 | The product does not comply because the estimated average content of Zinc is 141.0% of the label claim. As a result, this is outside the upper limit of the TGO 101 Schedule 2 requirements for the content of a mineral in a listed product of 90.0 - 125.0%. | The content of Zinc for the stated batch/es must be no less than 90% and no more than 141.0% of the stated content on the label. | Supply | Listed complementary medicines |
| CILICAINE VK phenoxymethylpenicillin (as potassium) 500 mg capsule blister pack | Viatris Pty Ltd | 339012 | CON-977 | The consent is effective from 1 August 2022 until 1 August 2023. | 1/08/2022 | Paragraph 8(1)(i), Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product label does not include the name and address of the current sponsor or supplier of the goods. | Import and supply | Prescription medicines | ||
| NEBILET nebivolol (as hydrochloride) 1.25 mg/5 mg composite starter titration tablet blister pack | A Menarini Australia Pty Ltd | 148895 | CON-976 | This consent is effective from 1 August 2022 until 31 December 2023. | 1/08/2022 | The current European Pharmacopeia (Ph. Eur.) monograph for Nebivolol hydrochloride | The products do not meet the Ph. Eur. monograph for Nebivolol hydrochloride analytical procedures used to determine Assay and Related Substances. | Import, supply and export | Prescription medicines | ||
| NEBILET nebivolol (as hydrochloride) 10 mg tablet blister pack | A Menarini Australia Pty Ltd | 148875 | CON-976 | This consent is effective from 1 August 2022 until 31 December 2023. | 1/08/2022 | The current European Pharmacopeia (Ph. Eur.) monograph for Nebivolol hydrochloride | The products do not meet the Ph. Eur. monograph for Nebivolol hydrochloride analytical procedures used to determine Assay and Related Substances. | Import, supply and export | Prescription medicines | ||
| NEBILET nebivolol (as hydrochloride) 5 mg tablet blister pack | A Menarini Australia Pty Ltd | 148874 | CON-976 | This consent is effective from 1 August 2022 until 31 December 2023. | 1/08/2022 | The current European Pharmacopeia (Ph. Eur.) monograph for Nebivolol hydrochloride | The products do not meet the Ph. Eur. monograph for Nebivolol hydrochloride analytical procedures used to determine Assay and Related Substances. | Import, supply and export | Prescription medicines | ||
| NEBILET nebivolol (as hydrochloride) 1.25 mg tablet blister pack | A Menarini Australia Pty Ltd | 148873 | CON-976 | This consent is effective from 1 August 2022 until 31 December 2023. | 1/08/2022 | The current European Pharmacopeia (Ph. Eur.) monograph for Nebivolol hydrochloride | The products do not meet the Ph. Eur. monograph for Nebivolol hydrochloride analytical procedures used to determine Assay and Related Substances. | Import, supply and export | Prescription medicines | ||
| DILANTIN PAEDIATRIC SUSPENSION phenytoin 30 mg/5 mL oral liquid bottle | Viatris Pty Ltd | 14309 | All batches released for supply from 29 July 2022 until 31 December 2023 | CON-975 | The consent is effective for all batches released for supply from 29 July 2022 until 31 December 2023. | 29/07/2022 | The product does not conform with the requirements of • European Pharmacopoeia (Ph. Eur.) general monograph 5.20 and British Pharmacopoeia (BP) general monograph SC IV Q for Elemental Impurities (i.e. adopted guideline of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3D Impurities - Guideline on Elemental impurities) | The product(s) exceed the ICH Q3D limits for Lead and Lithium for adults. | 1. The levels of lead and lithium present in the product must not exceed the Permitted Daily Exposure limits for children. 2. The products are supplied with the Dear Healthcare Practitioner letter provided to the Therapeutics Goods Administration via email on 2 August 2022. | Import and supply | Prescription medicines |
| NOUMED CELECOXIB celecoxib 200 mg hard capsule blister pack | AVALLON PHARMACEUTICALS PTY LTD | 285668 | NOAC101, NOAC102 NOAC103 | CON-974 | The consent is effective from 26 July 2022 until 31 August 2023 or until the relvant batch/es are exhausted . | 26/07/2022 | Subsection 9(1) Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The name of the medicine is equally conspicuous across 3 label panels, hence, each panel could be considered a 'main label' on the product(s). | Supply | Prescription medicines | |
| NOUMED CELECOXIB celecoxib 100 mg hard capsule blister pack | AVALLON PHARMACEUTICALS PTY LTD | 285667 | NOAB101,NOAB102 NOAB103 | CON-974 | The consent is effective from 26 July 2022 until 31 August 2023 or until the relvant batch/es are exhausted . | 26/07/2022 | Subsection 9(1) Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The name of the medicine is equally conspicuous across 3 label panels, hence, each panel could be considered a 'main label' on the product(s). | Supply | Prescription medicines | |
| NASONEX aqueous nasal spray mometasone furoate 50 microgram/actuation (as monohydrate) spray bottle | Organon Pharma PTY LTD | 77112 | U014537 | CON-973 | The consent is effective from 26 July 2022 until 30 November 2022 or until the relevant batch/es are exhausted. | 26/07/2022 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The labels do not include the current sponsor details (Organon Pharma Pty Ltd). | Import and supply | Prescription medicines | |
| ARABLOC leflunomide 20 mg tablet bottle | Sanofi-Aventis Australia Pty Ltd | 92754 | 9U88A | CON-972 | The consent is effective from 25 July 2022 until 25 July 2023. | 25/07/2022 | Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95) subsection 9(1), 9(2) and 9(3) | The sponsor does not hold and could not provide evidence of compliance with a standard mentioned in Subsesction 9(1) of TGO 95. | Approval has been granted for replacement TGO 95-compliant packaging for all future batches. | Supply | Prescription medicines |
| ARABLOC leflunomide 10 mg tablet bottle | Sanofi-Aventis Australia Pty Ltd | 92753 | 1RU9C | CON-972 | The consent is effective from 25 July 2022 until 25 July 2023. | 25/07/2022 | Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95) subsection 9(1), 9(2) and 9(3) | The sponsor does not hold and could not provide evidence of compliance with a standard mentioned in Subsesction 9(1) of TGO 95. | Approval has been granted for replacement TGO 95-compliant packaging for all future batches. | Supply | Prescription medicines |
| ARAVA Leflunomide 20 mg tablet bottle | Sanofi-Aventis Australia Pty Ltd | 69694 | 1RV4A | CON-972 | The consent is effective from 25 July 2022 until 25 July 2023. | 25/07/2022 | Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95) subsection 9(1), 9(2) and 9(3) | The sponsor does not hold and could not provide evidence of compliance with a standard mentioned in Subsesction 9(1) of TGO 95. | Approval has been granted for replacement TGO 95-compliant packaging for all future batches. | Supply | Prescription medicines |
| ARAVA Leflunomide 10 mg tablet bottle | Sanofi-Aventis Australia Pty Ltd | 69692 | 1PN6A | CON-972 | The consent is effective from 25 July 2022 until 25 July 2023. | 25/07/2022 | Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95) subsection 9(1), 9(2) and 9(3) | The sponsor does not hold and could not provide evidence of compliance with a standard mentioned in Subsesction 9(1) of TGO 95. | Approval has been granted for replacement TGO 95-compliant packaging for all future batches. | Supply | Prescription medicines |
| PAXLOVID nirmatrelvir 150 mg tablet and ritonavir 100 mg tablet blister composite pack | Pfizer Australia Pty Ltd | 389801 | CON-971 | The consent is effective for all batches released for supply from the 20 July 2022 until 20 January 2024. | 20/07/2022 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | The product is non-compliant in that the labels are international labels. The main deficiencies with regards to compliance with TGO 91 are with the carton labels and are as follows • The quantity of the drug substances are not closely associated with their names in a cohesive unit on the main label • Signal words and cautionary statement required by the Poison Standard for a prescription only medicine are absent • The ARTG number is absent • The contact details for the Australian sponsor are absent | 1. The product must be supplied with the labels that were considered and agreed to as part of the submission, being * Carton label * Blister label | Import and supply | Prescription medicines | |
| NICABATE MINI LOZENGES nicotine 4 mg (as polacrilex) mint flavour lozenge tube (new formulation) | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 392046 | CON-970 | The consent is effective from the 19 July 2022 until the 19 July 2024. | 19/07/2022 | The requirements of Therapeutic Goods Order No. 92 - Standard for label of non-prescription medicines (TGO 92), paragraphs 9(7)(i) and 10(7). | The product is non-compliant in that the container labels do not conform with the following requirements The product name and active ingredient name and quantity are displayed in a text size of less than 2 mm in height; and the quantity of the medicine in the container is displayed in a text size of less than 1.5 mm. | Import, supply and export | Over-the-counter medicines | ||
| NICABATE MINI LOZENGES nicotine 2 mg (as polacrilex) mint flavour lozenge tube | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 392045 | CON-970 | The consent is effective from the 19 July 2022 until the 19 July 2024. | 19/07/2022 | The requirements of Therapeutic Goods Order No. 92 - Standard for label of non-prescription medicines (TGO 92), paragraphs 9(7)(i) and 10(7). | The product is non-compliant in that the container labels do not conform with the following requirements The product name and active ingredient name and quantity are displayed in a text size of less than 2 mm in height; and the quantity of the medicine in the container is displayed in a text size of less than 1.5 mm. | Import, supply and export | Over-the-counter medicines | ||
| DEXAMETHASONE MYLAN dexamethasone phosphate (as dexamethasone sodium phosphate) 8 mg/2 mL solution for injection vial | Alphapharm Pty Ltd | 163199 | CON-968 | The consent is effective for all relevant batches of the product from the 15 July 2022 until 28 February 2023. | 15/07/2022 | The product does not conform with the requirements of the British Pharmacopeia monograph for Dexamethasone Sodium Phosphate Injection. | The product is non-compliant with the British Pharmacopeia monograph in that it does not meet the pH acceptance requirements. This consent does not apply to any product with a pH greater than or equal to 9.0. | 1. A ‘Dear Healthcare Provider’ letter identical to that provided to the TGA on 15 July 2022 will be supplied with each affected batch. 2. The Sponsor must inform the Therapeutics Goods Administration immediately by writing to the decision delegate if any batch of the product is analysed and the results obtained for pH are greater than or equal to pH 9.0. | Import and supply | Prescription medicines | |
| Caruso's Exit Pain Arthritis Cream | Caruso's Natural Health Pty Ltd | 383253 | CON-967 | The consent is effective from the 15 July 2022 until 1 July 2023. | 15/07/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | The products are non compliant in that the name of the medicine on the main label is not presented in a continuous, uninterrupted manner and is broken up by additional information and graphics. | Supply and export | Listed complementary medicines | ||
| Caruso's Prostate Eze Max | Caruso's Natural Health Pty Ltd | 367190 | CON-967 | The consent is effective from the 15 July 2022 until 1 July 2023. | 15/07/2022 | Subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | The products are non compliant in that the name of the medicine on the main label is not presented in a continuous, uninterrupted manner and is broken up by additional information and graphics. | Supply and export | Listed complementary medicines | ||
| OLANZAPINE SANDOZ olanzapine 2. 5mg film coated tablet, blister pack | Sandoz Pty Ltd | 148450 | MB8452 | CON-966 | The consent is effective from 12 July 2022 until 12 October 2022. | 12/07/2022 | Paragraphs 10(14)(a)(vii) and (viii) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The affected batch (as listed in the TGA consent letter of 12 july 2022) of product blister pack does not include the relevant batch and expiry prefixes. | A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 29 June 2022 will be supplied with each affected batch | Import and supply | Prescription medicines |
| INQOVI 35/100 decitabine 35 mg and cedazuridine 100 mg tablet blister pack | Otsuka Australia Pharmaceutical Pty Ltd | 375556 | 1919298 | CON-965 | The consent is effective from 8 July 2022 until 31 January 2025 | 8/07/2022 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product does not comply with TGO 91 because it is labelled for the United States market and does not include the full name of the medicine; storage conditions in the required format; Australian sponsor or distributor details; declaration of “lactose as sugars”; name of the medicine on at least three non-opposing sides of the carton; space for dispensing label; and name and quantity of each active ingredient together on separate lines. | 1. A ‘Dear Doctor’ letter identical to that provided to the Therapeutic Goods Administration on 8 July 2022 will be supplied with each affected batch. 2. The labels to which this consent applies are those provided in the application dated 8 June 2022 3. the product(s) carton labels will be overstickered with * The Australian registration number * Australian sponsor or distributor details * The warning statements “PRESCRIPTION ONLY MEDICINE” and “KEEP OUT OF REACH OF CHILDREN” | Import and supply | Prescription medicines |
| DBL HEPARIN SODIUM (porcine mucous) 5000IU/0.2 mL injection BP ampoule | Pfizer Australia Pty Ltd | 16349 | 14 batches of the product manufactured and released to market after 30 June 2022 until 31 March 2023. | CON-964 | The consent is effective for the remaining 14 batches of the product manufactured at Wassenger Arzneimittelwerk GmbH released to market after 30 June 2022 until 31 March 2023. | 6/07/2022 | The product does not conform to the requirements of the British Pharmacopoeia 2022 | The product conforms to the requirements of the British Pharmacopeia 2021 rather than the British Pharmacopeia 2022. The differences between the compendial versions are (i) identification testing using electrophoresis rather than nuclear magnetic resonance spectrometry and (ii) change to the HPLC gradient ratio and change to the limit for any other peak for the Related Substance test a disregard limit of 0.02% corresponding to any other impurity rather than no peaks other than the peak due to dermatan sulfate and chondroitin sulfate are detected. | Import and supply | Prescription medicines | |
| AZEP NASAL SPRAY azelastine 125µg/actuation (as hydrochloride) nasal spray aerosol, pump actuated-metered dose | Viatris Pty Ltd | 104853 | F2200456 | CON-963 | The consent is effective from the 4 July 2022 until Batch F2200456 is depleted. | 4/07/2022 | Paragraphs 8(1)(f) and 8(1)(g) of the Therapeutic Goods Order No. 92 Standard for label of non-prescription medicines (TGO 92). | The product does not comply because the carton labels are missing the batch and expiry date prefixes, as required by TGO 92. | Supply | Over-the-counter medicines | |
| NUVAXOVID (SARS-CoV-2 rS [NVX-CoV2373]) COVID-19 VACCINE adjuvanted suspension for injection vial | Biocelect Pty Ltd | 355139 | CON-962 | The consent is effective from 1 July 2022 until 19 January 2024 | 1/07/2022 | Therapeutic Goods Order No. 91 − Standard for labels of prescription and related medicines (TGO 91). | The product does not comply with the requirements of TGO 91 in the labels are international labels | 1. The product must be supplied with the labels that were considered and agreed to as part of the evaluation under section 9D(3) of the Therapeutic Goods Act 1989, being * The international carton referred to in the submission as follows * Update of carton with the removal of two (2) agents for pH adjustment from the carton text as submitted 14 June 2022 Sodium hydroxide and hydrochloric acid. OR The labels that were considered and agreed to as part of the evaluation under section 25 of the Therapeutic Goods Act 1989, being the international vial and carton labels referred to in submission dated 19 January 2022 | Import and supply | Prescription medicines | |
| TRUXIMA rituximab (rch) 100 mg/ 10 mL concentrate solution for intravenous infusion | Celltrion Healthcare Australia Pty Ltd | 285816 | OC3C047 | CON-961 | The consent is effective from 1 July 2022 until 30 June 2023. | 1/07/2022 | Section 9(3)(b) Section 8 (1) (i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91). | The product label does not comply with TGO 91 in that Section 9(3)(b) – On the vial and the carton, the name of the active ingredient is separated from the name of the medicine by the route of administration. Section 8 (1) (i) – On the carton, the name and contact details of the sponsor or distributor of the medicine is not current. | A Dear Healthcare Professional letter identical to that provided to the Therapeutic Goods Administration on 30 June 2022 will be supplied with the affected batch warning that the product is a New Zealand labelled product supplied under Section 14 exemption. | Import and supply | Prescription medicines |
| SPIKEVAX (elasomeran) COVID-19 VACCINE 0.2 mg/mL suspension for injection vial | Moderna Australia Pty Ltd | 370599 | CON-960 | The consent is effective from the 24 June 2022 until 09 August 2023. | 24/06/2022 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | The product does not comply with TGO 91. Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) in that the carton labels are international labels. | The product must be supplied with the labels that were considered and agreed to as part of the evaluation under section 9D(3) of the Therapeutic Goods Act 1989, as stated in the letter of consent, dated 24 June 2022. | Import and supply | Prescription medicines | |
| TECHNESCAN SESTAMIBI kit for the preparation of technetium [99m Tc] sestamibi injection | Landauer Radiopharmaceuticals Pty Ltd | 170503 | CON-959 | The consent is effective from the 24 June 2022 until 1 June 2024. | 24/06/2022 | The current British Pharmacopoeia (BP) monograph for Copper Tetramibi Tetrafluoroborate for Radiopharmaceutical Preparations | The product(s) do not meet the following BP monograph acceptance criteria copper content limit of 10.04% - 11.04%, unspecified impurites limits of NMT 0.2%, total impurites limit of NMT 0.5% and water content limit of NMT 0.5%. | Import and supply | Prescription medicines | ||
| BICILLIN L-A-benzathine benzylpenicillin tetrahydrate 600,000 units/1.17 mL suspension for injection syringe with needle | Pfizer Australia Pty Ltd | 293456 | CH2830 and EA3123 | CON-958 | The consent is effective until 17 December 2022. | 20/06/2022 | United States Pharmacopeia-National Formulary (USP-NF) monograph for ‘Lecithin’ | The products do not conform with the requirements of the current version of the United States Pharmacopeia-National Formulary (USP-NF) monograph for ‘Lecithin’ because the products do not meet the specification for ‘Assay Content of Phospholipids’ of NLT 70.0% for phosphatidylcholine. | Supply | Prescription medicines | |
| BICILLIN L-A benzathine benzylpenicillin tetrahydrate 1,200,000 Units / 2.3 mL suspension for injection pre-filled syringe with needle | Pfizer Australia Pty Ltd | 147169 | AJ8715, CL0542, DT3091, EC7728, EP9412, FC3936 and FJ5143 | CON-958 | The consent is effective until 17 December 2022. | 20/06/2022 | United States Pharmacopeia-National Formulary (USP-NF) monograph for ‘Lecithin’ | The products do not conform with the requirements of the current version of the United States Pharmacopeia-National Formulary (USP-NF) monograph for ‘Lecithin’ because the products do not meet the specification for ‘Assay Content of Phospholipids’ of NLT 70.0% for phosphatidylcholine. | Supply | Prescription medicines | |
| Eau Thermale Avene Sunscreen Aqua-Fluid SPF 50+ | Pierre Fabre Australia Pty Ltd | 348810 | CON-987 | The consent is effective from 17 June 2022 until 31 December 2023. | 17/06/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | The products do not comply because the labels display the previous address (901/1 Elizabeth Plaza, North Sydney, NSW 2060) instead of the new address (Level 7, 32 Walker St, North Sydney, NSW 2060) of the sponsor. | The mail redirection must stay in place from the old sponsor address (901/1 Elizabeth Plaza, North Sydney, NSW 2060) to the new sponsor address (Level 7, 32 Walker St, North Sydney, NSW 2060) until the last stock supplied with the old address expires. | Import and supply | Listed complementary medicines | |
| Eau Thermale Avene Sunscreen Spray SPF 50+ | Pierre Fabre Australia Pty Ltd | 345626 | CON-987 | The consent is effective from 17 June 2022 until 31 December 2023. | 17/06/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | The products do not comply because the labels display the previous address (901/1 Elizabeth Plaza, North Sydney, NSW 2060) instead of the new address (Level 7, 32 Walker St, North Sydney, NSW 2060) of the sponsor. | The mail redirection must stay in place from the old sponsor address (901/1 Elizabeth Plaza, North Sydney, NSW 2060) to the new sponsor address (Level 7, 32 Walker St, North Sydney, NSW 2060) until the last stock supplied with the old address expires. | Import and supply | Listed complementary medicines | |
| Eau Thermale Avene Sunscreen Spray for Children SPF 50+ | Pierre Fabre Australia Pty Ltd | 345627 | CON-987 | The consent is effective from 17 June 2022 until 31 December 2023. | 17/06/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | The products do not comply because the labels display the previous address (901/1 Elizabeth Plaza, North Sydney, NSW 2060) instead of the new address (Level 7, 32 Walker St, North Sydney, NSW 2060) of the sponsor. | The mail redirection must stay in place from the old sponsor address (901/1 Elizabeth Plaza, North Sydney, NSW 2060) to the new sponsor address (Level 7, 32 Walker St, North Sydney, NSW 2060) until the last stock supplied with the old address expires. | Import and supply | Listed complementary medicines | |
| Eau Thermale Avene Sunscreen Emulsion SPF 50+ | Pierre Fabre Australia Pty Ltd | 346042 | CON-987 | The consent is effective from 17 June 2022 until 31 December 2023. | 17/06/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | The products do not comply because the labels display the previous address (901/1 Elizabeth Plaza, North Sydney, NSW 2060) instead of the new address (Level 7, 32 Walker St, North Sydney, NSW 2060) of the sponsor. | The mail redirection must stay in place from the old sponsor address (901/1 Elizabeth Plaza, North Sydney, NSW 2060) to the new sponsor address (Level 7, 32 Walker St, North Sydney, NSW 2060) until the last stock supplied with the old address expires. | Import and supply | Listed complementary medicines | |
| Eau Thermale Avene Sunscreen Lotion SPF 50+ | Pierre Fabre Australia Pty Ltd | 345625 | CON-987 | The consent is effective from 17 June 2022 until 31 December 2023. | 17/06/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | The products do not comply because the labels display the previous address (901/1 Elizabeth Plaza, North Sydney, NSW 2060) instead of the new address (Level 7, 32 Walker St, North Sydney, NSW 2060) of the sponsor. | The mail redirection must stay in place from the old sponsor address (901/1 Elizabeth Plaza, North Sydney, NSW 2060) to the new sponsor address (Level 7, 32 Walker St, North Sydney, NSW 2060) until the last stock supplied with the old address expires. | Import and supply | Listed complementary medicines | |
| Plasma for fractionation as per the Technical Master File (TMF) in Australia | Australian Red Cross Lifeblood | CON-957 | The consent is effective from 16 June 2022 until the following condition no longer remains true. | 16/06/2022 | Schedule 1 (10 (c)) Therapeutic Goods Order (TGO) 108, Standard for Human Cell and Tissue Products—Donor Screening Requirements | The product does not conform to the requirements of TGO 108, in that persons who have a tattoo performed at a licenced/registered tattoo parlour or cosmetic clinic in Australia can be accepted as a donor for plasma for fractionationonly with no deferral period from the time of the last tattoo procedure. | The consent to supply those goods that do not conform to standards is restricted to donors who donate plasma for fractionation and does not include fresh blood products intended for clinical use. | Supply | Blood, tissues, and biologicals | ||
| All blood components as per the Technical Master File (TMF) in Australia, including clinical components and plasma for fractionation, notwithstanding they do not conform to the requirements of Therapeutic Goods Order 102. | Australian Red Cross Lifeblood | CON-956 | The consent is effective from the 16 June 2022 until the following conditions no longer remain true. | 16/06/2022 | Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019 Subsection 7(1) that specifies the requirements in relation to blood and blood components as those set out in the Council of Europe Guide (CoE Guide) for the preparation, use and quality assurance of blood components (19th edition). | The donor deferral period for Australia is reduced from 12 months to 3 months for donors reporting the following activities • for male donors male-to-male sex• for female donors sex with a man who has ever had sex with a man• for transgender donors sexual contact with a male• sex work• sexual contact with a sex worker (male or female)Page 2 of 5• overseas sexual contact with a resident of a HIV high prevalence country• sexual contact with an injecting drug user (current or past)• sexual contact with a partner known to be infected with a blood-borne virus (HIV, HBV, HCV or HTLV) | * Should new information become available in the future that indicates the risk of transmission of infectious diseases from donors has increased, Australian Red Cross Lifeblood must submit this information to the Therapeutics Goods Administration and obtain approval to continue with this consent. * Due to uncertainty regarding the impact of this change on the rate of non-compliance to donor selection questions for Australian donors, Lifeblood should assess the non-compliance rate of high-risk donors and monitor the return rate for donors and provide this information to the Therapeutics Goods Administration for review within two years of the date of this approval. | Supply | Blood, tissues, and biologicals | ||
| AERON 500 ipratropium bromide (as monohydrate) 500 microgram/mL inhalation ampoule | Viatris Pty Ltd | 98648 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| AERON 250 ipratropium bromide (as monohydrate) 250 microgram/mL inhalation ampoule | Viatris Pty Ltd | 98647 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| CORDILOX 180 SR verapamil hydrochloride 180 mg tablet blister pack | Viatris Pty Ltd | 54033 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| ISOPTIN 180 SR 180 mg verapamil hydrochloride tablet blister pack | Viatris Pty Ltd | 54032 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| COUMADIN warfarin sodium 5mg tablet bottle | Viatris Pty Ltd | 42279 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| COUMADIN warfarin sodium 1mg tablet bottle | Viatris Pty Ltd | 42269 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| CILICAINE SYRINGE 1.5 procaine benzylpenicillin (procaine penicillin) 1.5g injection syringe | Viatris Pty Ltd | 288818 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| OXYCODONE VIATRIS oxycodone hydrochloride 5 mg tablet blister pack | Viatris Pty Ltd | 224758 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| IKOTAB nicorandil 10 mg tablet blister pack | Viatris Pty Ltd | 218690 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| IKOTAB nicorandil 20 mg tablet blister pack | Viatris Pty Ltd | 218689 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| XALAPROST latanoprost 50 microgram/mL eye drops bottle | Viatris Pty Ltd | 217151 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| XALAMOL 50/5 latanoprost 50 microgram/mL + timolol (as maleate) 5 mg/mL eye drops bottle | Viatris Pty Ltd | 217150 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| DYMISTA 125/50 azelastine (as hydrochloride) 125 microgram and fluticasone propionate 50 microgram nasal spray bottle | Viatris Pty Ltd | 203131 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| ENDONE oxycodone hydrochloride 5 mg tablet blister pack | Viatris Pty Ltd | 14945 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| COUMADIN warfarin sodium 2 mg tablet bottle | Viatris Pty Ltd | 14937 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| MAREVAN warfarin sodium 5 mg tablet bottle | Viatris Pty Ltd | 12514 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| MAREVAN warfarin sodium 3 mg tablet bottle | Viatris Pty Ltd | 12513 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| MAREVAN warfarin sodium 1 mg tablet bottle | Viatris Pty Ltd | 12511 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| QUESTRAN LITE colestyramine 850 mg/g powder sachet | Viatris Pty Ltd | 11971 | CON-955 | The consent is effective from the 15 June 2022 until 15 June 2023. | 15/06/2022 | Paragraph 8(1)(i) of Therapeutics Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product label does not include the name and address of the current sponsor or distributor of the goods. | The labels to which this consent applies are those previously approved for the former sponsor and arrangements are in place such that consumers and healthcare professionals will be redirected from the old (www.mylan.com.au) to the new website (www.viatris.com.au). | Import and supply | Prescription medicines | |
| IKERVIS ciclosporin 1 mg/mL eye drops emulsion ampoule | Seqirus Pty Ltd | 319502 | 7Q58 (7Q58V) and 2R08 (2R08G) | CON-953 | The consent is effective from the 8 June 2022 until 30 November 2022. | 8/06/2022 | Paragraphs 10(12)(c) and 10(12)(f) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product does not include the quantity of the medicine, nor the approved route of administration on the ampoule label. | A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Adimistration on 7 June 2022 will be supplied with each affected batch. | Import and supply | Prescription medicines |
| Xiao Feng San Capsule | JQ JQ Healthcare Products Pty Ltd | 154914 | CON-954 | The consent is effective from the 7 June 2022 until 21 April 2024. | 7/06/2022 | Section 6 of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | The product label incorrectly lists the spelling of the Approved Herbal Name (AHN) of the ingredient “Dictamnus dasycarpus” as “Dictamnus desycarpus”. | Import and supply | Listed complementary medicines | ||
| EVUSHELD tixagevimab 100 mg/ mL and cilgavimab 100 mg/ mL solution for injection in 150 mg single dose vials | AstraZeneca Pty Ltd | 378245 | CON-952 | The consent is effective from the 7 June 2022 until 30 May 2023 | 7/06/2022 | Section 6, Section 8(1)(d), Section 8(1)(i), Section 8(2), Section 9(1)(d), Section 9(3)(a) and (b), Section 9(5), Section 10(4)(f) Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product label does not comply with the TGO 91 regarding the following information A blanket exemption for TGO91 compliance is approved for the international artworks presented. The main non-compliances with TGO91 are • the excipients 'L-histidine' and 'L-histidine hydrochloride monohydrate' are not named as per the Australian Approved Names. • the dosage form 'solution for injection' is shown as ' injection' and 'each 1.5 mL of solution contains…' • the sponsor address is not included as they are international artworks. Details can be found by scanning the QR code or going to 'laab.azcovid-19.com'. • the international cartons do not include a dispensing label. • 'injection' is included on the main panel and 'solution' is included on the back panel as part of 'each 1.5mL of solution contains…' • the name of the medicine, active ingredient and quantity are not presented in the required cohesive layout. • the name of the active ingredients and quantity have a text height of less than 3.0 millimetres. • the dosage form is described as 'injection' on the vial labels. | A Dear Health Care Professional Letter (DHCPL) will be distributed for the Evusheld stock supplied in exempted international labels. The DHCPL will provide details on the label changes. | Import and supply | Prescription medicines | |
| NIZORAL 1% ANTI-DANDRUFF TREATMENT ketoconazole 10 mg/g application bottle (reformulation) | Key Pharmaceuticals Pty Ltd | 389572 | CON-951 | The consent is effective from the 6 June 2022 until the 6 June 2024 | 6/06/2022 | Related substances test and limits in the Ketoconazole Shampoo monograph of the British Pharmacopoeia (BP). | The products that do not conform to the requirements of the Act in that they do not comply with the related substances test and limits in the Ketoconazole Shampoo monograph of the British Pharmacopoeia (BP). | Import, supply and export | Over-the-counter medicines | ||
| NIZORAL 1% ANTI-DANDRUFF TREATMENT ketoconazole 10 mg/g application bottle (reformulation) | Key Pharmaceuticals Pty Ltd | 339871 | CON-951 | The consent is effective from the 6 June 2022 until the 6 June 2024 | 6/06/2022 | Related substances test and limits in the Ketoconazole Shampoo monograph of the British Pharmacopoeia (BP). | The products that do not conform to the requirements of the Act in that they do not comply with the related substances test and limits in the Ketoconazole Shampoo monograph of the British Pharmacopoeia (BP). | Import, supply and export | Over-the-counter medicines | ||
| VISINE CLEAR EYE DROPS tetryzoline hydrochloride 0.5 mg/ mL bottle (reformulation) | Johnson Johnson Pacific Limited | 332121 | CON-950 | The consent is effective from 6 June 2022 until 6 June 2024. | 6/06/2022 | pH limits for Tetrahydrozoline Hydrochloride Ophthalmic Solution monograph, United States Pharmacopoeia (USP). | The products that do not conform to the requirements of the Act in that they do not comply with the pH limits for Tetrahydrozoline Hydrochloride Ophthalmic Solution monograph, USP. | Import, supply and export | Over-the-counter medicines | ||
| VISINE ADVANCED EYE DROPS tetryzoline hydrochloride 0.5 mg/ mL bottle (reformulation) | Johnson Johnson Pacific Limited | 332120 | CON-950 | The consent is effective from 6 June 2022 until 6 June 2024. | 6/06/2022 | pH limits for Tetrahydrozoline Hydrochloride Ophthalmic Solution monograph, United States Pharmacopoeia (USP). | The products that do not conform to the requirements of the Act in that they do not comply with the pH limits for Tetrahydrozoline Hydrochloride Ophthalmic Solution monograph, USP. | Import, supply and export | Over-the-counter medicines | ||
| ZADITEN ketotifen 250 microgram/ mL eye drops, solution ampoule | Novartis Pharmaceuticals Australia Pty Ltd | 113770 | CON-949 | The consent is effective from 2 June 2022 until 1 October 2026. | 2/06/2022 | Subsection 10(7) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92) | The product that does not conform to the requirements of subsection 10(7) of TGO 92 in that the ampoule labels • do not include the quantity of the medicine in the container, • do not include the name of the sponsor or distributor (or a registered trademark that readily identifies the sponsor or distributor), and • do not comply with the text height requirements for small containers. | Supply | Over-the-counter medicines | ||
| PANADOL CHILDREN 5 - 12 YEARS paracetamol 48 mg/mL oral suspension bottle (Orange - Colourfree) | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 178303 | CON-1034 | The consent is effective from 1 June 2022 until 1 June 2023. | 1/06/2022 | of United States Pharmacopoeia | The products that do not conform to the requirements of the USP with respect to test and limits for “Deliverable volume <698>” | supply | Over-the-counter medicines | ||
| PANADOL CHILDREN 5 - 12 YEARS paracetamol 48 mg/mL oral suspension bottle (Strawberry - Colourfree) | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 178302 | CON-1034 | The consent is effective from 1 June 2022 until 1 June 2023. | 1/06/2022 | of United States Pharmacopoeia | The products that do not conform to the requirements of the USP with respect to test and limits for “Deliverable volume <698>” | supply | Over-the-counter medicines | ||
| BENPEN benzylpenicillin (as sodium) 600 mg powder for injection vial | Seqirus Pty Ltd | 10329 | CON-948 | The consent for subsection (1) is in effect from 1 June 2022 until 31 May 2024 | 1/06/2022 | Section 1.1(2)(e) of part 2 of the current Poisons Standard | The requirement in Section 1.1(2)(e) of Part 2 of the current Poisons Standard does not apply to a word, expression or statement on a container (which has a capacity of 20 mL or less), or on the label of such a container, of the specified products as the use of letters smaller than 1.5 mm in height is approved. Note Under section 1.1(3)(b) of part 2 of the current Poisons Standard, the letters on a container, or label of a container, of the specified products must be at least 1 mm in height. | Import and supply | Prescription medicines | ||
| BENPEN benzylpenicillin (as sodium) 3 g powder for injection vial | Seqirus Pty Ltd | 10327 | CON-948 | The consent for subsection (1) is in effect from 1 June 2022 until 31 May 2024 | 1/06/2022 | Section 1.1(2)(e) of part 2 of the current Poisons Standard | The requirement in Section 1.1(2)(e) of Part 2 of the current Poisons Standard does not apply to a word, expression or statement on a container (which has a capacity of 20 mL or less), or on the label of such a container, of the specified products as the use of letters smaller than 1.5 mm in height is approved. Note Under section 1.1(3)(b) of part 2 of the current Poisons Standard, the letters on a container, or label of a container, of the specified products must be at least 1 mm in height. | Import and supply | Prescription medicines | ||
| BENPEN benzylpenicillin (as sodium) 1.2 g powder for injection vial | Seqirus Pty Ltd | 10326 | CON-948 | The consent for subsection (1) is in effect from 1 June 2022 until 31 May 2024 | 1/06/2022 | Section 1.1(2)(e) of part 2 of the current Poisons Standard | The requirement in Section 1.1(2)(e) of Part 2 of the current Poisons Standard does not apply to a word, expression or statement on a container (which has a capacity of 20 mL or less), or on the label of such a container, of the specified products as the use of letters smaller than 1.5 mm in height is approved. Note Under section 1.1(3)(b) of part 2 of the current Poisons Standard, the letters on a container, or label of a container, of the specified products must be at least 1 mm in height. | Import and supply | Prescription medicines | ||
| BENPEN benzylpenicillin (as sodium) 600 mg powder for injection vial | Seqirus Pty Ltd | 10329 | CON-947 | The consent is effective for all relevant batches supplied from 1 June 2022 until 1 June 2024. | 1/06/2022 | Paragraph 8(1)(b) of TGO 91 of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with Paragraph 8(1)(b) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) in that the name of the active ingredients is incorrect according to the AAN. | Regulatory action is to be taken to correct the name of the active ingredient on the product(s) labels and in the ARTG entry within the next three months, or when the next batch is imported, whichever is sooner. Upon correction of the name of the active ingredient on the product(s) labels and in the ARTG entry, these corrections are to be communicated to healthcare professionals to avoid any confusion regarding the amount of active ingredient present in the product(s). | Import and supply | Prescription medicines | |
| BENPEN benzylpenicillin (as sodium) 3 g powder for injection vial | Seqirus Pty Ltd | 10327 | CON-947 | The consent is effective for all relevant batches supplied from 1 June 2022 until 1 June 2024. | 1/06/2022 | Paragraph 8(1)(b) of TGO 91 of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with Paragraph 8(1)(b) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) in that the name of the active ingredients is incorrect according to the AAN. | Regulatory action is to be taken to correct the name of the active ingredient on the product(s) labels and in the ARTG entry within the next three months, or when the next batch is imported, whichever is sooner. Upon correction of the name of the active ingredient on the product(s) labels and in the ARTG entry, these corrections are to be communicated to healthcare professionals to avoid any confusion regarding the amount of active ingredient present in the product(s). | Import and supply | Prescription medicines | |
| BENPEN benzylpenicillin (as sodium) 1.2 g powder for injection vial | Seqirus Pty Ltd | 10326 | CON-947 | The consent is effective for all relevant batches supplied from 1 June 2022 until 1 June 2024. | 1/06/2022 | Paragraph 8(1)(b) of TGO 91 of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with Paragraph 8(1)(b) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) in that the name of the active ingredients is incorrect according to the AAN. | Regulatory action is to be taken to correct the name of the active ingredient on the product(s) labels and in the ARTG entry within the next three months, or when the next batch is imported, whichever is sooner. Upon correction of the name of the active ingredient on the product(s) labels and in the ARTG entry, these corrections are to be communicated to healthcare professionals to avoid any confusion regarding the amount of active ingredient present in the product(s). | Import and supply | Prescription medicines | |
| DULOSE lactulose 667 mg/mL oral liquid bottle | Viatris Pty Ltd | 220095 | CON-946 | The consent is effective from 25 may 2022 until 26 May 2023. | 25/05/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92) | The products are non-compliant with paragraph 8(1)(i) of the Therapeutic Goods Order No. 92, in that the labels display the name of the previous sponsor (Mylan Health Pty Ltd) instead of the name of the new sponsor (Viatris Pty Ltd). | Import and supply | Over-the-counter medicines | ||
| BECONASE ALLERGY HAYFEVER beclometasone dipropionate 0.5mg/g (50 micrograms per actuation) aqueous nasal spray bottle | Viatris Pty Ltd | 72345 | CON-946 | The consent is effective from 25 may 2022 until 26 May 2023. | 25/05/2022 | paragraph 8(1)(i) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92) | The products are non-compliant with paragraph 8(1)(i) of the Therapeutic Goods Order No. 92, in that the labels display the name of the previous sponsor (Mylan Health Pty Ltd) instead of the name of the new sponsor (Viatris Pty Ltd). | Import and supply | Over-the-counter medicines | ||
| DEXAMETHASONE MYLAN dexamethasone phosphate (as dexamethasone sodium phosphate) 4 mg/1 mL solution for injection vial | Alphapharm Pty Ltd | 163200 | 7607283, 7607284 and 7607285 | CON-945 | The consent is effective from 23 May 2022 until 23 November 2022. | 23/05/2022 | The requirements of the BP monograph for Dexamethasone Sodium Phosphate Injection. | The product do not conform to the requirements of the BP monograph for Dexamethasone Sodium Phosphate Injection, in that the product does not meet the pH requirements in the monograph. | A ‘Dear Healthcare Provider’ letter identical to that provided to the TGA on 20 May 2022 will be supplied with each affected batch. | Import and supply | Prescription medicines |
| ZADITEN ketotifen 250 microgram/mL eye drops bottle | Novartis Pharmaceuticals Australia Pty Ltd | 99979 | 1R77C 7Q08D | CON-944 | The consent is effective from 19 May 2022 until the batches affected are expired. | 19/05/2022 | Therapeutic Goods Order No.92 – Standard for labels of non-prescription medicines | The product in Australia notwithstanding they do not conform with the requirements of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines on the basis that you have been adversely impacted by COVID-19. | Supply | Over-the-counter medicines | |
| RAFEN GEL CAPSULES ibuprofen 200 mg capsules blister pack | Alphapharm Pty Ltd | 230365 | NHR00121 NHR00221 | CON-943 | The consent is effective from 18 May until the batches have expired (due October 2024) | 18/05/2022 | Section 6 of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92) | The product does not comply because the expiry date prefix printed on the blister labels as ‘E’ does not have the characteristics specified in Section 6 of TGO 92 – Standard for labels of non-prescription medicines. | Import and supply | Over-the-counter medicines | |
| MOVICOL JUNIOR LEMON-LIME FLAVOUR powder for oral solution sachet | Norgaine Pty Ltd | 109758 | CON-942 | The consent is effective from 18 May 2022 until 31 December 2022. | 18/05/2022 | Therapeutic Goods Order No.92 – Standard for labels of non-prescription medicines but are labelled in accordance with the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | The products that do not conform with the Therapeutic Goods Order No.92 – Standard for labels of non-prescription medicines on the basis that the company have been adversely impacted by COVID-19. | Supply | Over-the-counter medicines | ||
| CERNEVIT multivitamin powder for injection vial | Baxter Healthcare Pty Ltd | 92418 | CON-941 | The consent is effective from 16 May 2022 until 3 September 2024. | 16/05/2022 | Paragraph 10(4)(d) of Therapeutic Goods Order No. 91 - Standards for labels of prescription and related medicines (TGO 91) | The product does not conform to the requirements of Paragraph 10(4)(d) of TGO 91 - Standards for labels of prescription and related medicines, in that the product text height of the names of all active ingredients on vial labels is 1.5 mm, below the required text size of not less than 2.0 millimetres. | The labels to which this consent applies are those provided in the related request under s. 9D(3) for variation to the entry. | Import, supply and export | Prescription medicines | |
| OPTIRAY 320 Ioversol 135.6 g/200 mL injection vial | Guerbet Australia Pty Ltd | 49425 | 20F1245, 21H1495 and 21L2255 | CON-940 | The consent is effective for the aforementioned batches only from 16 May 2022 until 17 May 2023. | 16/05/2022 | Subsection 9(3) and paragraphs 8(1)(d), 8(1)(e), 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(d), 10(2)(a), 10(3)(a), and 10(4)(f) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with the following requirements of subsection 9(3) and paragraphs 8(1)(d), 8(1)(e), 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(d), 10(2)(a), 10(3)(a), and 10(4)(f) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) in that The vial outer carton labels (for the AUST R 49423 and AUST R 49425 products) do not include the approved name of dosage form; do not include the quantity of the medicine; do not include the approved storage conditions (i.e., “Store below 25°C. Do not Freeze. Protect from light”); do not include the Australian sponsor details; do not include a machine-readable code; do not include the name of the medicine on three non-opposing sides; do not include the name of the medicine and the name and quantity of the active ingredient as a cohesive unit. The vial (hanger) labels (for the AUST R 49423 and AUST R 49425 products) do not include the approved name of dosage form; do not include the approved storage conditions (i.e., “Store below 25°C. Do not Freeze. Protect from light”); do not include a machine-readable code; do not include the name of the medicine and the name and quantity of the active ingredient as a cohesive unit; do not include the name and quantity of the excipients; do not include the statement ‘Use in one patient on one occasion only’ or words to that effect. The syringe outer carton labels (for the AUST R 46642 product) do not include the approved name of dosage form; do not include the approved storage conditions (i.e., “Store below 25°C. Do not Freeze. Protect from light”); do not include the Australian sponsor details; do not include a machine-readable code; do not include the name of the medicine on three non-opposing sides. The syringe labels and the syringe intermediate labels (for the AUST R 46642 product) do not include the approved name of dosage form; do not include the approved storage conditions (i.e., “Store below 25°C. Do not Freeze. Protect from light”); do not include a machine-readable code; do not include the name and quantity of the excipients; do not include the statement ‘Use in one patient on one occasion only’ or words to that effect. | 1. A Dear Healthcare Professional letter identical to that provided with the application dated 11 May 2022 will be supplied with each affected batch. 2. The AUST R will be over-stickered on the carton as advised in the email correspondence to the Therapeutics Goods Administration dated 13 May 2022. 3. The labels to which this consent applies are those provided with the application dated 13 May 2022. | Import and supply | Prescription medicines |
| OPTIRAY 320 Ioversol 67.8 g/100 mL injection vial | Guerbet Australia Pty Ltd | 49423 | 20F1245 and 21J1925 | CON-940 | The consent is effective for the aforementioned batches only from 16 May 2022 until 17 May 2023. | 16/05/2022 | Subsection 9(3) and paragraphs 8(1)(d), 8(1)(e), 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(d), 10(2)(a), 10(3)(a), and 10(4)(f) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with the following requirements of subsection 9(3) and paragraphs 8(1)(d), 8(1)(e), 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(d), 10(2)(a), 10(3)(a), and 10(4)(f) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) in that The vial outer carton labels (for the AUST R 49423 and AUST R 49425 products) do not include the approved name of dosage form; do not include the quantity of the medicine; do not include the approved storage conditions (i.e., “Store below 25°C. Do not Freeze. Protect from light”); do not include the Australian sponsor details; do not include a machine-readable code; do not include the name of the medicine on three non-opposing sides; do not include the name of the medicine and the name and quantity of the active ingredient as a cohesive unit. The vial (hanger) labels (for the AUST R 49423 and AUST R 49425 products) do not include the approved name of dosage form; do not include the approved storage conditions (i.e., “Store below 25°C. Do not Freeze. Protect from light”); do not include a machine-readable code; do not include the name of the medicine and the name and quantity of the active ingredient as a cohesive unit; do not include the name and quantity of the excipients; do not include the statement ‘Use in one patient on one occasion only’ or words to that effect. The syringe outer carton labels (for the AUST R 46642 product) do not include the approved name of dosage form; do not include the approved storage conditions (i.e., “Store below 25°C. Do not Freeze. Protect from light”); do not include the Australian sponsor details; do not include a machine-readable code; do not include the name of the medicine on three non-opposing sides. The syringe labels and the syringe intermediate labels (for the AUST R 46642 product) do not include the approved name of dosage form; do not include the approved storage conditions (i.e., “Store below 25°C. Do not Freeze. Protect from light”); do not include a machine-readable code; do not include the name and quantity of the excipients; do not include the statement ‘Use in one patient on one occasion only’ or words to that effect. | 1. A Dear Healthcare Professional letter identical to that provided with the application dated 11 May 2022 will be supplied with each affected batch. 2. The AUST R will be over-stickered on the carton as advised in the email correspondence to the Therapeutics Goods Administration dated 13 May 2022. 3. The labels to which this consent applies are those provided with the application dated 13 May 2022. | Import and supply | Prescription medicines |
| OPTIRAY 320 Ioversol 84.75 g/125 mL injection syringe (power injector) | Guerbet Australia Pty Ltd | 46642 | 21E0912 | CON-940 | The consent is effective for the aforementioned batches only from 16 May 2022 until 17 May 2023. | 16/05/2022 | Subsection 9(3) and paragraphs 8(1)(d), 8(1)(e), 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(d), 10(2)(a), 10(3)(a), and 10(4)(f) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with the following requirements of subsection 9(3) and paragraphs 8(1)(d), 8(1)(e), 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(d), 10(2)(a), 10(3)(a), and 10(4)(f) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) in that The vial outer carton labels (for the AUST R 49423 and AUST R 49425 products) do not include the approved name of dosage form; do not include the quantity of the medicine; do not include the approved storage conditions (i.e., “Store below 25°C. Do not Freeze. Protect from light”); do not include the Australian sponsor details; do not include a machine-readable code; do not include the name of the medicine on three non-opposing sides; do not include the name of the medicine and the name and quantity of the active ingredient as a cohesive unit. The vial (hanger) labels (for the AUST R 49423 and AUST R 49425 products) do not include the approved name of dosage form; do not include the approved storage conditions (i.e., “Store below 25°C. Do not Freeze. Protect from light”); do not include a machine-readable code; do not include the name of the medicine and the name and quantity of the active ingredient as a cohesive unit; do not include the name and quantity of the excipients; do not include the statement ‘Use in one patient on one occasion only’ or words to that effect. The syringe outer carton labels (for the AUST R 46642 product) do not include the approved name of dosage form; do not include the approved storage conditions (i.e., “Store below 25°C. Do not Freeze. Protect from light”); do not include the Australian sponsor details; do not include a machine-readable code; do not include the name of the medicine on three non-opposing sides. The syringe labels and the syringe intermediate labels (for the AUST R 46642 product) do not include the approved name of dosage form; do not include the approved storage conditions (i.e., “Store below 25°C. Do not Freeze. Protect from light”); do not include a machine-readable code; do not include the name and quantity of the excipients; do not include the statement ‘Use in one patient on one occasion only’ or words to that effect. | 1. A Dear Healthcare Professional letter identical to that provided with the application dated 11 May 2022 will be supplied with each affected batch. 2. The AUST R will be over-stickered on the carton as advised in the email correspondence to the Therapeutics Goods Administration dated 13 May 2022. 3. The labels to which this consent applies are those provided with the application dated 13 May 2022. | Import and supply | Prescription medicines |
| SEPTRIN sugar-free oral liquid bottle | Arrow Pharmaceuticals Pty Ltd | 11000 | 911803, 915472, 926133, 934351 934352 | CON-938 | The consent is effective from the 10 may 2022 until 18 March 2024. | 10/05/2022 | The USP monograph for Sulfamethoxazole and Trimethoprim Oral Suspension. | The product does not conform to the requirements of the USP monograph for Sulfamethoxazole and Trimethoprim Oral Suspension, in that the product(s) do not meet the USP drug product monograph acceptance criteria for Any other unspecified degradation product of NMT 0.2%. | A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration on 03 May 2022 will be supplied with each affected batch requesting that the Product is to be used immediately or before April 2023 and that the shelf life will be reduced to 18 months. | Supply | Prescription medicines |
| DIFFLAM PLUS SORE THROAT SPRAY ANAESTHETIC + ANTIBACTERIAL + ANTI-INFLAMMATORY TRIPLE ACTION pump actuated metered dose aerosol bottle | iNova Pharmaceuticals (Australia) Pty Ltd | 322041 | CON-939 | The consent is effective from 9 May 2022 until 10 May 2024. | 9/05/2022 | Section 9 of the Therapeutic Goods Order No.92 – Standard for labels of non-prescription medicines. | The products that do not conform to the requirements of Section 9 of the Therapeutic Goods Order No.92 – Standard for labels of non-prescription medicines, in that the main label of the container (bottle) does not display the full name of the active ingredients (which includes chemical salts and hydration states) and the quantity of each of the active ingredients, but instead only displays the name of the therapeutically active moieties of the active ingredients. | Supply | Over-the-counter medicines | ||
| Nourex Professional Cranberry X50000 | PBA Wholesale Pty Ltd | 375555 | CON-937 | The consent is effective from 5 May 2022 until 5 May 2023. | 5/05/2022 | 9(1b) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product that does not conform to the requirements of the Information to be included on the main label section 9(1b) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines in that a misprint on the product label states “Vaccinium macrocarpon fruit extract dry concentrate 500mg” instead of “Vaccinium macrocarpon fruit powder 500mg”. The error implies that the formulation source of Vaccinium macrocarpon is derived from a dry concentrate when it is derived from a fruit powder. | Supply | Blood, tissues, and biologicals | ||
| ANDRODERM testosterone 24.3 mg per patch transdermal drug delivery system sachet | Teva Pharma Australia Pty Ltd | 82398 | 100024620 and 100030031 | CON-936 | The consent is effective from 28 April 2022 until 28 April 2024. | 28/04/2022 | Subsection 9(3)(a), Section 9(5) and Subsection 8(1)(j) of the Therapeutic Goods Order No.91 - Standard for labels of prescription and related medicines (TGO 91) | The product(s) do not conform to the requirements of TGO 91 Subsection 9(3)(a), Section 9(5) and Subsection 8(1)(j), in that the product(s) tradename, active ingredient and strength do not appear together; the active ingredient on the main label is displayed in a text size height of 2.5 millimetres; and ethanol is not declared on the carton label. | Supply | Prescription medicines | |
| TRAMAL tramadol hydrochloride 50 mg capsule blister pack | Seqirus Pty Ltd | 64011 | CON-935 | The consent is effective from 27 April 2022 until 31 March 2023. | 27/04/2022 | Subsection 9(3) of Therapeutic Goods Order No. 91 (TGO 91) | The product does not conform to the requirements of Subsection 9(3) of TGO 91, in that the ‘name of the medicine’ and the ‘name and quantity of active ingredient’ are not included as a cohesive unit on the carton label. | Supply | Prescription medicines | ||
| VASOCARDOL CD diltiazem hydrochloride 360 mg capsule bottle | Sanofi-Aventis Australia Pty Ltd | 75253 | CON-934 | The consent is effective from 27 April 2021 until 31 July 2022. | 27/04/2022 | Subsection 17(2) of the Therapeutic Goods Order No. 101 - Standard for Tablets, Capsules and Pills (TGO 101) | The product(s) do not conform to the requirements of subsection 17(2) of the Therapeutic Goods Order No. 101 - Standard for Tablets, Capsules and Pills (TGO 101), in that the product(s) do not meet the approved dissolution limits after long term storage. | The extent of the non-compliance is only as described in the application dated 9 September 2021 and reiterated in this application dated 6 April 2022. | Import and supply | Prescription medicines | |
| CARDIZEM CD diltiazem hydrochloride 360 mg capsule bottle. | Sanofi-Aventis Australia Pty Ltd | 75251 | CON-934 | The consent is effective from 27 April 2021 until 31 July 2022. | 27/04/2022 | Subsection 17(2) of the Therapeutic Goods Order No. 101 - Standard for Tablets, Capsules and Pills (TGO 101) | The product(s) do not conform to the requirements of subsection 17(2) of the Therapeutic Goods Order No. 101 - Standard for Tablets, Capsules and Pills (TGO 101), in that the product(s) do not meet the approved dissolution limits after long term storage. | The extent of the non-compliance is only as described in the application dated 9 September 2021 and reiterated in this application dated 6 April 2022. | Import and supply | Prescription medicines | |
| DILTIAZEM SANDOZ CD diltiazem hydrochloride 360 mg capsule bottle (unprinted) | Sanofi-Aventis Australia Pty Ltd | 131304 | CON-934 | The consent is effective from 27 April 2021 until 31 July 2022. | 27/04/2022 | Subsection 17(2) of the Therapeutic Goods Order No. 101 - Standard for Tablets, Capsules and Pills (TGO 101) | The product(s) do not conform to the requirements of subsection 17(2) of the Therapeutic Goods Order No. 101 - Standard for Tablets, Capsules and Pills (TGO 101), in that the product(s) do not meet the approved dissolution limits after long term storage. | The extent of the non-compliance is only as described in the application dated 9 September 2021 and reiterated in this application dated 6 April 2022. | Import and supply | Prescription medicines | |
| FOSCAVIR foscarnet sodium 6 g/250 mL injection bottle | Link Medical Products Pty Ltd TA Link Pharmaceuticals | 37310 | 16QC0624 | CON-933 | The consent is effective for import and supply of batch 16QC0624 in Australia from 26 April 2022 until 30 June 2022. | 26/04/2022 | Paragraphs 8(1)(k), 8(1)(b), 8(1)(i), 9(1)(b), 9(3)(a), 10(2)(a); Subsection 9(3); and Subparagraphs 7(2)(d)(i), 11(2)(f)(iii) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product(s) do not conform to the requirements of Paragraphs 8(1)(k), 8(1)(b), 8(1)(i), 9(1)(b), 9(3)(a), 10(2)(a); Subsection 9(3); and Subparagraphs 7(2)(d)(i), 11(2)(f)(iii) of TGO 91. The product(s) labels do not include the relevant signal heading and warning statements, include the name of the active ingredient in accordance with its Australian Approved Name, include the name and address of the Australian sponsor, place the name and quantity of the active ingredient on the main label together immediately below the name of the medicine, print the name of the active ingredient at a height of 3 mm or larger, include the quantity of each excipient or express the strength of the medicine as the weight of the active ingredient in the stated volume of injection. | 1. A ‘Dear Healthcare Provider’ letter identical to that provided to the TGA on 8 December 2021 will be supplied with each affected batch outlining the differences in the product labelling. 2. The labels to which this consent applies are those provided with your letter dated 8 December 2021 and over-stickered with the Australian sponsor details and the AUST R number. | Import and supply | Prescription medicines |
| VAMIN 18 ELECTROLYTE FREE 500 mL injection bottle | Fresenius Kabi Australia Pty Ltd | 14454 | CON-932 | The consent is effective from 26 April 2022 until 31 December 2023. | 26/04/2022 | Paragraphs 8(1)(h), 8(1)(i) and 10(2)(f) of Therapeutic Goods Order 91 (TGO 91) | The product does not conform to the requirements of Paragraphs 8(1)(h), 8(1)(i) and 10(2)(f) of Therapeutic Goods Order 91, in that the product labels (carton and bottle) do not include the storage conditions applicable to the medicine i.e., ‘Store below 25°C. Do not freeze’; do not include the Australian sponsor details; and do not include the statement ‘Use in one patient on one occasion only. Contains no antimicrobial preservative’ or words to that effect. | 1. A customer letter identical to that provided in the email correspondence to the TGA dated 21 April 2022 will be supplied with each affected batch. 2. Supply and use of the above referenced batch are restricted to the circumstances proposed in the application [use in the compounding facility (Slade Health) only]. 3. The AUST R will be over-stickered on the carton as advised in your application dated 5th April 2022. 4. The labels to which this consent applies are those provided with the application in the email correspondence dated 5th April 2022. | Import and supply | Prescription medicines | |
| Xiao Feng San Capsule | JQ JQ Healthcare Products Pty Ltd | 154914 | CON-931 | The consent is effective from the 21 April 2022 until 21 April 2023. | 21/04/2022 | Section 6 of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | The products label incorrectly lists the spelling of the Approved Herbal Name (AHN) of the ingredient “Dictamnus dasycarpus” as “Dictamnus desycarpus”. | All future cartons and labels of the affected product/s contain the correct spelling of the Approved herbal Name (AHN) of the ingredient Dictamnus dasycarpus. | Import and supply | Listed complementary medicines | |
| TCM Eczema Relief – [Si Wu Xiao Feng Jiao Nang] | Cathay Herbal Laboratories | 137287 | CON-930 | The consent is effective from the 21 April 2022 until 21 April 2024. | 21/04/2022 | Section 6 of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | The products label incorrectly lists the spelling of the Approved Herbal Name (AHN) of the ingredient “Dictamnus dasycarpus” as “Dictamnus desycarpus”. | All future cartons and labels of the affected product/s contain the correct spelling of the Approved herbal Name (AHN) of the ingredient Dictamnus dasycarpus. | Import and supply | Listed complementary medicines | |
| TCM DETOX FORMULA – [BEI XIE SHENG SHI PIAN] | Cathay Herbal Laboratories | 125315 | CON-930 | The consent is effective from the 21 April 2022 until 21 April 2024. | 21/04/2022 | Section 6 of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | The products label incorrectly lists the spelling of the Approved Herbal Name (AHN) of the ingredient “Dictamnus dasycarpus” as “Dictamnus desycarpus”. | All future cartons and labels of the affected product/s contain the correct spelling of the Approved herbal Name (AHN) of the ingredient Dictamnus dasycarpus. | Import and supply | Listed complementary medicines | |
| QU SHI BAO TONG CHONG JI - [Skin Formula] | Cathay Herbal Laboratories | 63887 | CON-930 | The consent is effective from the 21 April 2022 until 21 April 2024. | 21/04/2022 | Section 6 of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | The products label incorrectly lists the spelling of the Approved Herbal Name (AHN) of the ingredient “Dictamnus dasycarpus” as “Dictamnus desycarpus”. | All future cartons and labels of the affected product/s contain the correct spelling of the Approved herbal Name (AHN) of the ingredient Dictamnus dasycarpus. | Import and supply | Listed complementary medicines | |
| BEI XIE SHENG SHI WAN [Tokoro Coix Combination] | Cathay Herbal Laboratories | 11661 | CON-930 | The consent is effective from the 21 April 2022 until 21 April 2024. | 21/04/2022 | Section 6 of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | The products label incorrectly lists the spelling of the Approved Herbal Name (AHN) of the ingredient “Dictamnus dasycarpus” as “Dictamnus desycarpus”. | All future cartons and labels of the affected product/s contain the correct spelling of the Approved herbal Name (AHN) of the ingredient Dictamnus dasycarpus. | Import and supply | Listed complementary medicines | |
| SHI DU QING | Shen Neng Herbal Medicines Group Pty Ltd | 75334 | CON-929 | The consent is effective from the 21 April 2022 until 21 April 2023. | 21/04/2022 | Section 6 of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | The products label incorrectly lists the spelling of the Approved Herbal Name (AHN) of the ingredient “Dictamnus dasycarpus” as “Dictamnus desycarpus. | All future cartons and labels of the affected product/s contain the correct spelling of the Approved herbal Name (AHN) of the ingredient Dictamnus dasycarpus. | Import and supply | Listed complementary medicines | |
| Double Prawn Brand Herbal Oil | Well Herb Pty Ltd | 329181 | CON-928 | The consent is effective from the 21 April 2022 until 21 April 2023. | 21/04/2022 | Section 6 of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | The products label incorrectly lists the spelling of the Approved Herbal Name (AHN) of the ingredient “Dictamnus dasycarpus” as “Dictamnus desycarpus”. | 1. All future cartons and labels of the affected product/s contain the correct spelling of the Approved herbal Name (AHN) of the ingredient Dictamnus dasycarpus. | Import and supply | Listed complementary medicines | |
| Sou Du Wan Ying | Wai Shun Pty Ltd | 148285 | CON-927 | The consent is effective from the 21 April 2022 until 21 April 2023. | 21/04/2022 | Section 6 of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. | The products label incorrectly lists the spelling of the Approved Herbal Name (AHN) of the ingredient “Dictamnus dasycarpus” as “Dictamnus desycarpus”. | 1. All future cartons and labels of the affected product/s contain the correct spelling of the Approved herbal Name (AHN) of the ingredient Dictamnus dasycarpus. | Import and supply | Listed complementary medicines | |
| Psoriasis Relief Capsule | GreenOZ Pty Ltd | 356599 | CON-926 | The consent is effective from the 20 april 2022 until 20 April 2023. | 20/04/2022 | Section 6 of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product label incorrectly lists the spelling of the Approved Herbal Name (AHN) of the ingredient Dictamnus dasycarpus as Dictamnus desycarpus. | 1. All future cartons and labels of the affected product/s contain the correct spelling of the Approved herbal Name (AHN) of the ingredient Dictamnus dasycarpus. | Import and supply | Listed complementary medicines | |
| PAXLOVID nirmatrelvir 150 mg tablet and ritonavir 100 mg tablet blister composite pack | Pfizer Australia Pty Ltd | 377572 | CON-925 | The consent is effective for all batches released for supply from the 20 April 2022 until 18 January 2024. | 20/04/2022 | Does not conform with the requirements of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | The product does not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | The product must be supplied with the carton and blister labels that were considered and agreed to as part of the submission dated 19 April 2022. | Import and supply | Prescription medicines | |
| blood components including red cells, platelets, plasma for transfusion and plasma for fractionation as defined in the Lifeblood TMF | Australian Red Cross Lifeblood | CON-969 | The consent is effective from the 19 April 2022 | 19/04/2022 | The Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019; Section 7(4) and Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) Schedule 1 Item 8(b). | The blood components including red cells, platelets, plasma for transfusion and plasma for fractionation, will not comply with the requirement of indefinite geographical deferral for variant Creutzfeldt-Jakob disease (vCJD) risk, applicable to blood and plasma donors having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996. Blood and plasma donors will not be deferred for potential environmental exposure to vCJD for having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996. | That Lifeblood continues to monitor the literature and informs the Therapeutic Goods Administration of any new evidence that substantively alters the estimated risks, such that they become unacceptable. | Supply | Blood, tissues, and biologicals | ||
| IKERVIS ciclosporin 1 mg/mL eye drops emulsion ampoule | Seqirus Pty Ltd | 319502 | 4Q36K-R | CON-924 | The consent is effective from 13 April 2022 until batch 4Q36K-R is exhausted. | 13/04/2022 | Paragraphs 10(12)(d) and 10(12)(e) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines. | The product ampoule does not state the batch number of the medicine preceded by the batch number prefix and the expiry date of the medicine preceded by the expiry date prefix. | 1. The carton and intermediate foil labels are the currently approved labels and instruct patients to keep the ampoules in the pouch. The carton and intermediate foil labels are over stickered with the revised batch and expiry details as outlined in the letter of application. 2. Explanatory letters will be provided advising wholesalers, prescribers and pharmacists about why this batch has been overstickered and, to alert them to the discrepancy between the expiry date on the ampoule and that on the foil pouch and outer carton. | Supply | Prescription medicines |
| Skin - Johnson Johnson Medical Pty Ltd t/a DePuy Synthes | Johnson Johnson Medical Pty Ltd t/a DePuy Synthes | 211608 | CON-923 | The consent is effective from the 12 April 2022 until 11 April 2024. | 12/04/2022 | clause 12(2) of 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 and clause 15(1) of Therapeutic Goods (Standards for Biologicals—General and Specific Requirements) (TGO 109) Order 2021. | The products that do not conform to the requirements of clause 12(2) of TGO 88 and clause 15(1) of TGO 109, in that the biological starting material will commence within 24 hours after asystole and be completed within 36 hours of asystole. | Import and supply | Blood, tissues, and biologicals | ||
| CIPLA ISOPRENALINE isoprenaline hydrochloride 1.0 mg/5 mL injection solution ampoule | Cipla Australia Pty Ltd | 379570 | CON-922 | The consent is effective from 8 April 2022 until 30 September 2022. | 8/04/2022 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) carton label does not include a machine readable code; the name and quantity of all excipients; the name of substances with known effect (sugars as lactose); the name of the active ingredient as per the AAN; the name of the medicine on three non-opposing sides of the carton; space for a dispensing label; 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. Additionally, the ampoule label does not state the name of the medicine; 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. | 1. A ‘Dear Healthcare Professional’ letter identical to that provided to the TGA on 29 March 2022 will be supplied with each affected batch. 2. The carton label will be overstickered with Australia-specific information, as outlined in the communication of 6 April 2022, including the AUST R number. | Supply | Prescription medicines | |
| CIPLA ISOPRENALINE isoprenaline hydrochloride 0.2 mg/1 mL injection solution ampoule | Cipla Australia Pty Ltd | 356387 | CON-922 | The consent is effective from 8 April 2022 until 30 September 2022. | 8/04/2022 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product(s) carton label does not include a machine readable code; the name and quantity of all excipients; the name of substances with known effect (sugars as lactose); the name of the active ingredient as per the AAN; the name of the medicine on three non-opposing sides of the carton; space for a dispensing label; 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. Additionally, the ampoule label does not state the name of the medicine; 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. | 1. A ‘Dear Healthcare Professional’ letter identical to that provided to the TGA on 29 March 2022 will be supplied with each affected batch. 2. The carton label will be overstickered with Australia-specific information, as outlined in the communication of 6 April 2022, including the AUST R number. | Supply | Prescription medicines | |
| XEVUDY sotrovimab 500 mg/8 mL concentrated injection solution for infusion, vial | GlaxoSmithKline Australia Pty Ltd | 364110 | CON-920 | The consent is effective from 24 March 2022 until 17 August 2023. | 24/03/2022 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | The following elements of the packaging do not comply with Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) VIALTGO 91, subsections 10(4) - the vial label does not include the name of the the dosage form as approved in Australia. CARTONTGO 91, section 8(1)(d),(h),(i),(k) - the name of dosage is not in accordance with the TGA approved name, the storage conditions Store in a refrigerator is not in accordance with the TGA approved storage condition of 2°C to 8°C, the name and details of the Australian Sponsor are not included although the GSK logo is included and relevant signal headings and warning statements are not included. TGO 91, section 8(2) - no space is available for the dispensing label. TGO 91, section 9(1)(d),(e),(g)- the name of the dosage form is not in accordance with the TGA approved name, the quantitiy of medicine is not included on main panel, the statement IV for infusion are not placed adjacent to one another. TGO 91, section 9(3) - The name of the medicine and the active ingredient do not appear together as a cohesive unit on the main panel. TGO 91, section 10(3)(a) - each excipient in the medicine is stated, however, the quantity of each ingredient is not included and names are not in accordance with AAN. TGO 91, section 10(3)(b) - a statement Use in one patient on one occasion only. Contains no antimicrobial preservative or words to that effect is not included. | Import and supply | Prescription medicines | ||
| PRIMENE 10% amino acids solution for injection bottle | Baxter Healthcare Pty Ltd | 79618 | CON-919 | The consent is effective from 21 March 2022 until 31 March 2024. | 21/03/2022 | Subsections 9(3) and 9(6), paragraph 11(1)(a) and subparagraph 11(2)(d)(ii) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product does not confirm with the requirements of subsections 9(3) and 9(6), paragraph 11(1)(a) and subparagraph 11(2)(d)(ii) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91), in that the product bottle labels do not list the names and quantities of the twenty (20) active ingredients on separate lines under the trade name and in a text size of not less than 2.5 millimetres, do not express the quantities of the active ingredients using the required statements of mass and do not list the weight of each active ingredient in a stated volume of the medicine after preparation. | The labels to which this consent applies are those approved and dated 12 March 2019. | Import, supply and export | Prescription medicines | |
| STAY SAFE BALANCE 4.25% glucose 1.25mmol/L calcium peritoneal dialysis solution bag | Fresenius Medical Care Australia Pty Ltd | 92959 | CON-918 | The consent is effective from 16 March 2022 until 1 March 2024. | 16/03/2022 | Section 6, subsections 8(2), 9(3A), 9(6), 9(8) and 11(5); and paragraphs 8(1)(a), 8(1)(d), 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(a), 9(1)(d), 10(8)(f) and 11(1)(c) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform to the requirements of Section 6, subsections 8(2), 9(3A), 9(6), 9(8) and 11(5); and paragraphs 8(1)(a), 8(1)(d), 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(a), 9(1)(d), 10(8)(f) and 11(1)(c) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the products labels do not state the active ingredients in accordance with their Australian Approved Name, the medicine name is more prominent on the side panel rather than the main label, do not include the medicine name and dosage form as per the ARTG, do not include the storage conditions in the required format, do not state the name and contact details of the Australian sponsor or distributor, do not include a machine readable code, do not include space for a dispensing label, lists the name and quantity of active ingredients for the combined product and not that of individual components, are printed with active ingredients in a text size that does not meet the requirements, do not include the statement “Use in one patient on one occasion only. Contains no antimicrobial preservative” or words to this effect and do not express the units for volume in accordance with the required AAN format. | 1. The labels to which this consent applies are those provided with the letter dated 18 January 2022. 2. A customer letter identical to the one provided in the communication dated 14 March 2022 will be supplied with each affected batch. | Import and supply | Prescription medicines | |
| SLEEP SAFE BALANCE 4.25% glucose 1.25 mmol/L calcium peritoneal dialysis solution bag | Fresenius Medical Care Australia Pty Ltd | 92943 | CON-918 | The consent is effective from 16 March 2022 until 1 March 2024. | 16/03/2022 | Section 6, subsections 8(2), 9(3A), 9(6), 9(8) and 11(5); and paragraphs 8(1)(a), 8(1)(d), 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(a), 9(1)(d), 10(8)(f) and 11(1)(c) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform to the requirements of Section 6, subsections 8(2), 9(3A), 9(6), 9(8) and 11(5); and paragraphs 8(1)(a), 8(1)(d), 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(a), 9(1)(d), 10(8)(f) and 11(1)(c) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the products labels do not state the active ingredients in accordance with their Australian Approved Name, the medicine name is more prominent on the side panel rather than the main label, do not include the medicine name and dosage form as per the ARTG, do not include the storage conditions in the required format, do not state the name and contact details of the Australian sponsor or distributor, do not include a machine readable code, do not include space for a dispensing label, lists the name and quantity of active ingredients for the combined product and not that of individual components, are printed with active ingredients in a text size that does not meet the requirements, do not include the statement “Use in one patient on one occasion only. Contains no antimicrobial preservative” or words to this effect and do not express the units for volume in accordance with the required AAN format. | 1. The labels to which this consent applies are those provided with the letter dated 18 January 2022. 2. A customer letter identical to the one provided in the communication dated 14 March 2022 will be supplied with each affected batch. | Import and supply | Prescription medicines | |
| Human plasma for fractionation - plasma obtained by plasmapheresis intended solely for the recovery of proteins that are not labile in plasma. | Australian Red Cross Lifeblood | CON-921 | The consent is effective from 3 March 2022 until the following condition no longer remains true. | 3/03/2022 | The European Pharmacopoeia monograph Human plasma for fractionation (0853) | The product does not conform to the requirements of the European Pharmacopoeia monograph Human plasma for fractionation (0853), in that plasma when obtained by plasmapheresis, and intended solely for the recovery of proteins that are not labile in plasma, is separated from cellular components and frozen in a chamber at -20°C or below within 72 hours of collection rather than 24 hours. | This consent is limited to collection centres directly impeded by limited product transport options for transporting plasma to a processing centre within the required timeframe associated with the weather events occurring in NSW and Qld in March 2022. This consent is effective until the implicated transport options are resolved. Lifeblood must advise TGA when the transport options for the affected collection centres have been resolved. | Supply | Blood, tissues, and biologicals | ||
| HEXVIX hexaminolevulinate (as hydrochloride) 85 mg powder for intravesical solution plus diluent | Juno Pharmaceuticals Pty Ltd | 318359 | HA2904 | CON-917 | The consent is effective from 28 February 2022 until 28 February 2023. | 28/02/2022 | Paragraph 8(1)(h) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product does not conform to the requirements of paragraph 8(1)(h) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91), in that the product displays previously approved storage conditions ‘Store below 25°C’ instead of the current approved storage conditions ‘Store below 30°C’. | The labels to which this consent applies are those supplied with the letter dated 1 February 2022. | Import and supply | Prescription medicines |
| WP CARBIMAZOLE 5 carbimazole 5 mg tablet blister pack | Seed Pharma Pty Ltd | 349095 | 200328, 200329A, 210029, 210030, 210031, 210033, 210035, 210132, 210133, 210134, 210034 and 200337 | CON-916 | The consent is effective from 23 February 2022 until 31 March 2023 or until the batches are exhausted. | 23/02/2022 | Subparagraphs 10(14)(a)(iv) and 10(14)(a)(ix) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product does not conform to the requirements of subparagraphs 10(14)(a)(iv) and 10(14)(a)(ix) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91), in that the product blister foil labels do not state the name of the medicine and the name or identifier of the Australian sponsor. | 1. The blister labels to which this consent applies are those provided with the application and packaged in the Australian approved carton labels as agreed with the Therapeutic Goods Administration on 26 November 2021. 2. A ‘Dear Pharmacist’ letter identical to that agreed with the Therapeutic Goods Administration on 16 December 2021 advising them to remind patients to keep the blister packs with the correctly labelled carton, must be provided with each of the affected batches. | Supply | Prescription medicines |
| TEPMETKO tepotinib 225 mg (as hydrochloride monohydrate) tablet blister pack | Merck Healthcare Pty Ltd | 370977 | CON-915 | The consent is effective for all relevant batches released from 21 February 2022 until 31 December 2022. | 21/02/2022 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product does not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91), in that the product is packed in US labelled blister foils. The blisters are packed in US labelled cartons which are overstickered with Australian labels, including the AUST R number. | 1. A Dear Healthcare Professional letter identical to that provided to the Therapeutic Goods Administration on 11 February 2022 will be supplied with each affected batch. 2. The Australian PI and CMI documents will be supplied with each affected batch. | Import and supply | Prescription medicines | |
| ADDAVEN concentrated injection ampoule | Fresenius Kabi Australia Pty Ltd | 244493 | 12RAB94 | CON-914 | The consent is effective from 18 February 2022 until 31 December 2023. | 18/02/2022 | Paragraphs 8(1)(i), 10(2)(a) and 10(2)(f) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product does not conform to the requirements of paragraphs 8(1)(i), 10(2)(a) and 10(2)(f) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91), in that the product does not contain the name and contact details of the sponsor, name and quantity of each excipient in the stated volume of fill of the injection in the container, or the statement ‘Use in one patient in one occasion only. Contains no antimicrobial preservative'. | 1. A customer letter identical to that provided to the TGA on 18 February 2022 will be supplied with each affected batch. 2. Supply and use of the above referenced batch are restricted to the circumstances proposed in the application (use in compounding facilities only). 3. The AUST R will be over-stickered on the carton as advised in the letter dated 24 January 2022. | Import and supply | Prescription medicines |
| Itchy baby co. Eczema Moisturiser | Netura Pty Ltd | 309391 | 21076D and 21075D | CON-913 | The consent is effective from 16 February 2022 until 29 February 2024. | 16/02/2022 | Subsection 9(2), paragraphs 9(3a) and 9(3b) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product does not conform to the requirements of subsection 9(2), paragraphs 9(3a) and 9(3b) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the product name on the main label is not presented in a continuous, uninterrupted manner, the name of the active ingredients on the main label does not appear immediately below the name of the medicine and the active ingredients of the product are found below a descriptive summary of the products action and not directly below the product name. | Supply | Listed complementary medicines | |
| Metamucil Wild Berry Smooth psyllium husk powder | Procter Gamble Australia Pty Ltd | 153182 | CON-911 | The consent is effective from 9 February 2022 until 30 June 2022. | 9/02/2022 | Subparagraph 9(3)(a)(i), paragraph 9(3)(b) and subsection 8(2) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines | The products do not conform with the requirements of subparagraph 9(3)(a)(i), paragraph 9(3)(b) and subsection 8(2) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines but are fully compliant with all requirements of Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | Supply | Registered complementary medicines | ||
| METAMUCIL NATURAL GRANULAR | Procter Gamble Australia Pty Ltd | 10186 | CON-911 | The consent is effective from 9 February 2022 until 30 June 2022. | 9/02/2022 | Subparagraph 9(3)(a)(i), paragraph 9(3)(b) and subsection 8(2) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines | The products do not conform with the requirements of subparagraph 9(3)(a)(i), paragraph 9(3)(b) and subsection 8(2) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines but are fully compliant with all requirements of Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | Supply | Registered complementary medicines | ||
| METAMUCIL ORANGE GRANULAR | Procter Gamble Australia Pty Ltd | 10184 | CON-911 | The consent is effective from 9 February 2022 until 30 June 2022. | 9/02/2022 | Subparagraph 9(3)(a)(i), paragraph 9(3)(b) and subsection 8(2) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines | The products do not conform with the requirements of subparagraph 9(3)(a)(i), paragraph 9(3)(b) and subsection 8(2) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines but are fully compliant with all requirements of Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | Supply | Registered complementary medicines | ||
| METAMUCIL LEMON LIME SMOOTH psyllium husk powder 578mg/g jar | Procter Gamble Australia Pty Ltd | 47538 | CON-911 | The consent is effective from 9 February 2022 until 30 June 2022. | 9/02/2022 | Subparagraph 9(3)(a)(i), paragraph 9(3)(b) and subsection 8(2) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines | The products do not conform with the requirements of subparagraph 9(3)(a)(i), paragraph 9(3)(b) and subsection 8(2) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines but are fully compliant with all requirements of Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | Supply | Registered complementary medicines | ||
| METAMUCIL ORANGE SMOOTH psyllium husk powder 535mg/g jar | Procter Gamble Australia Pty Ltd | 47537 | CON-911 | The consent is effective from 9 February 2022 until 30 June 2022. | 9/02/2022 | Subparagraph 9(3)(a)(i), paragraph 9(3)(b) and subsection 8(2) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines | The products do not conform with the requirements of subparagraph 9(3)(a)(i), paragraph 9(3)(b) and subsection 8(2) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines but are fully compliant with all requirements of Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | Supply | Registered complementary medicines | ||
| DIPROSONE betamethasone 0.47 mg/mL (as dipropionate) lotion bottle | Organon Pharma Pty Ltd | 18829 | B64103 | CON-910 | The consent is effective for the aforementioned batches only from 7 February 2022 until 30 May 2022. | 7/02/2022 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO91) | The products do not comform with the requirement of paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO91) in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd). | That arrangements are in place with the former sponsor Merck Sharp and Dohme for the prompt referral of any queries or complaints concerning the products to Organon. | Import and supply | Prescription medicines |
| DIPROSONE betamethasone 0.5 mg/g (as dipropionate) cream tube | Organon Pharma Pty Ltd | 18818 | T039029 | CON-910 | The consent is effective for the aforementioned batches only from 7 February 2022 until 30 May 2022. | 7/02/2022 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO91) | The products do not comform with the requirement of paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO91) in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd). | That arrangements are in place with the former sponsor Merck Sharp and Dohme for the prompt referral of any queries or complaints concerning the products to Organon. | Import and supply | Prescription medicines |
| VEKLURY remdesivir 100 mg powder for injection vial | Gilead Sciences Pty Ltd | 338419 | CON-907 | The consent is effective from 4 February 2022 until 10 July 2022. | 4/02/2022 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product does not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | 1. The labels to which this consent applies are those provided with the request, submitted 3 February 2022 . 2. A 'Medicines Fact Sheet' will be supplied with the affected batch that will detail the appropriate use and storage of the product in accordance with the approved Australian Product Information (PI). | Import and supply | Prescription medicines | |
| GRAZAX standardised allergen extract of grass pollen from Timothy grass (Phleum pratense) 75,000 SQ-T sublingual tablets blister foil | Seqirus Pty Ltd | 267955 | CON-906 | The consent is effective from 31 January 2022 until 1 March 2024. | 31/01/2022 | Subparagraphs 10(14)(a)(v) and 10(14)(a)(ix) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO91) | The product does not conform to the requirements of subparagraphs 10(14)(a)(v) and 10(14)(a)(ix) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO91), in that the name of the active ingredient (phleum pratense) is not included and the name of the sponsor is not included. | The GRAZAX label exempted from TGO 91 is identical to that has been approved by the TGA and presented with the submission. | Import, supply and export | Prescription medicines | |
| FOSCAVIR foscarnet sodium 6g/250 mL injection bottle | Link Medical Products Pty Ltd TA Link Pharmaceuticals | 37310 | 16QC0624 | CON-905 | The consent is effective for import and supply of batch 16QC0624 in Australia from 31 January 2022 until 4 May 2022. | 31/01/2022 | Paragraphs 8(1)(k), 8(1)(b), 8(1)(i), 9(1)(b), 9(3)(a), 10(2)(a); subsection 9(3); and subparagraphs 7(2)(d)(i), 11(2)(f)(iii) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product does not conform to the requirements of paragraphs 8(1)(k), 8(1)(b), 8(1)(i), 9(1)(b), 9(3)(a), 10(2)(a); subsection 9(3); and subparagraphs 7(2)(d)(i), 11(2)(f)(iii) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91), in that the product labels do not - include the relevant signal heading and warning statements, - include the name of the active ingredient in accordance with its Australian Approved Name, - include the name and address of the Australian sponsor, - place the name and quantity of the active ingredient on the main label together immediately below the name of the medicine, - print the name of the active ingredient at the required minimum height of 3 mm, - include the quantity of each excipient, - include the Registration number on the carton or primary pack - express the strength of the medicine as the weight of the active ingredient in the stated volume of injection. | 1. A 'Dear Healthcare Provider' letter identical to that provided to the TGA on 8 December 2021 will be supplied with each affected batch outlining the differences in the product labelling. 2. The labels to which this consent applies are those provided with the letter dated 8 December 2021 and over-stickered with the Australian sponsor details and the AUST R number. | Import and supply | Prescription medicines |
| DRAXIMAGE MACROSALB kit for the preparation of Technetium Tc 99m Albumin Aggregated Injection vial | Jubilant Pharma Australia Pty Ltd | 315902 | CON-903 | The consent is effective from 28 January 2022 until 30 April 2022. | 28/01/2022 | Paragraphs 8(1)(n) (o), 9(1)(b)(c) (e), subparagraph 9(3)(a)(i), subsection 9(5) and paragraphs 10(4)(d) (k) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The product does not conform to the requirements of paragraphs 8(1)(n) amp; (o), 9(1)(b)(c) amp; (e), subparagraph 9(3)(a)(i), subsection 9(5) and paragraphs 10(4)(d) amp; (k) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that There is no machine readable code on the carton; and the name of the medicine is on three sides but they are not non-opposing.The name and quantity of the active ingredient on the main label is not indicated (Albumin Aggregated 2.5 mg), and the quantity of medicine (10 reaction vials) on the main label is not indicated.The name of the active ingredient is not mentioned immediately below the name of the medicine.The name and the quantity of the active ingredient (Albumin Aggregated 2.5 mg) should be added in a text size of not less than 3.0 millimetres.The name and the quantity of the active ingredient (Albumin Aggregated 2.5 mg) is already on the vial label with a text size of 1.7 mm but was considered non-compliant on the basis of additional information provided in the request; and the route of administration is not included on the vial label. | Import and supply | Prescription medicines | ||
| ACARIZAX Standardised allergen extract from American house dust mite extract European house dust mite extract 12 SQ-HDM sublingual tablet | Seqirus Pty Ltd | 250392 | CON-904 | The consent is effective for all batches from 27 January 2022 until 6 February 2024. | 27/01/2022 | Subparagraphs 10(14)(a)(v) and 10(14)(a)(ix) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO91) | The product does not conform to the requirements of subparagraphs 10(14)(a)(v) and 10(14)(a)(ix) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO91), in that The name of the active ingredient (American house dust mite extract amp; European house dust mite extract) is not included.The name of the sponsor is not included. | The ACARIZAX label exempted from TGO 91 requirements is identical to that approved by the Therapeutic Goods Administration and presented with the submission. | Import and supply | Prescription medicines | |
| ADT BOOSTER diphtheria and tetanus vaccine, adsorbed suspension for injection syringe | Seqirus Pty Ltd | 130919 | CON-902 | The consent is effective from 24 January 2022 and only applicable to stock imported into Australia prior to 1 August 2022. | 24/01/2022 | Section 6 and paragraph 8(1)(i) of Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform to the requirements of Section 6 and paragraph 8(1)(i) of Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), in that the contact details (current address) of the Distributor are not provided on the label of the medicine. | 1. The consent should apply only to stock imported into Australia with a manufacture date before 1 August 2022. 2. The carton labels to which this consent applies are those approved 13 December 2019. | Import and supply | Prescription medicines | |
| ADT BOOSTER diphtheria and tetanus vaccine, adsorbed suspension for injection vial | Seqirus Pty Ltd | 130906 | CON-902 | The consent is effective from 24 January 2022 and only applicable to stock imported into Australia prior to 1 August 2022. | 24/01/2022 | Section 6 and paragraph 8(1)(i) of Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform to the requirements of Section 6 and paragraph 8(1)(i) of Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), in that the contact details (current address) of the Distributor are not provided on the label of the medicine. | 1. The consent should apply only to stock imported into Australia with a manufacture date before 1 August 2022. 2. The carton labels to which this consent applies are those approved 13 December 2019. | Import and supply | Prescription medicines | |
| Sunitinib Sandoz sunitinib 12.5 mg capsule blister | Sandoz Pty Ltd | 318077 | 1XB01A | CON-901 | The consent is effective for the aforementioned batches only from 19 January 2022 until 19 January 2024 or until the batches are depleted. | 19/01/2022 | Paragraphs 8(1)(f) and 8(1)(g) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with the requirements of paragraphs 8(1)(f) and 8(1)(g) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the blister labels do not include batch and expiry prefixes. | A Dear Healthcare Professional letter identical to that provided with the letter of application dated 9 November 2021 will be supplied with each affected batch. | Import and supply | Prescription medicines |
| Sunitinib Sandoz sunitinib 25 mg capsule blister | Sandoz Pty Ltd | 318075 | 1XC01A | CON-901 | The consent is effective for the aforementioned batches only from 19 January 2022 until 19 January 2024 or until the batches are depleted. | 19/01/2022 | Paragraphs 8(1)(f) and 8(1)(g) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with the requirements of paragraphs 8(1)(f) and 8(1)(g) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the blister labels do not include batch and expiry prefixes. | A Dear Healthcare Professional letter identical to that provided with the letter of application dated 9 November 2021 will be supplied with each affected batch. | Import and supply | Prescription medicines |
| Sunitinib Sandoz sunitinib 37.5 mg capsule blister | Sandoz Pty Ltd | 318074 | 1XD01A | CON-901 | The consent is effective for the aforementioned batches only from 19 January 2022 until 19 January 2024 or until the batches are depleted. | 19/01/2022 | Paragraphs 8(1)(f) and 8(1)(g) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with the requirements of paragraphs 8(1)(f) and 8(1)(g) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the blister labels do not include batch and expiry prefixes. | A Dear Healthcare Professional letter identical to that provided with the letter of application dated 9 November 2021 will be supplied with each affected batch. | Import and supply | Prescription medicines |
| Sunitinib Sandoz sunitinib 50 mg capsule blister | Sandoz Pty Ltd | 318073 | 1XE01A | CON-901 | The consent is effective for the aforementioned batches only from 19 January 2022 until 19 January 2024 or until the batches are depleted. | 19/01/2022 | Paragraphs 8(1)(f) and 8(1)(g) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with the requirements of paragraphs 8(1)(f) and 8(1)(g) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the blister labels do not include batch and expiry prefixes. | A Dear Healthcare Professional letter identical to that provided with the letter of application dated 9 November 2021 will be supplied with each affected batch. | Import and supply | Prescription medicines |
| LAGEVRIO molnupiravir 200 mg capsules bottle | Merck Sharp Dohme Pty Ltd | 372650 | CON-909 | The consent is effective for all batches released for supply from 18 January 2022 until 18 January 2024. | 18/01/2022 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product does not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | The product must be supplied with the labels that were considered and agreed to as part of the evaluation under section 25 of the Therapeutic Goods Act 1989, being a. The international label as follows i. Carton labels (submitted 16 November 2021) ii. Bottle labels (submitted 16 November 2021) | Import and supply | Prescription medicines | |
| PAXLOVID nirmatrelvir 150 mg tablet and ritonavir 100 mg tablet blister composite pack | Pfizer Australia Pty Ltd | 377572 | CON-908 | The consent is effective for all batches released for supply from 18 January 2022 until 18 January 2024. | 18/01/2022 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product does not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | The product must be supplied with the labels that were considered and agreed to as part of the evaluation under section 25 of the Therapeutic Goods Act 1989, being a. The international label as follows i. Carton label (submitted 15 November 2021) ii. Blister label (submitted 15 November 2021) | Import and supply | Prescription medicines | |
| ALUSTAL HOUSE DUST MITES EXTRACT INITIAL TREATMENT european house dust mite and american house dust mite injection suspension vial composite pack | Stallergenes Australia Pty Ltd | 132725 | CON-900 | The consent is effective from 18 January 2022 until further notice. | 18/01/2022 | Default standard for bacterial endotoxin (Ph. Eur. 2.6.14 and 5.1.10) | The products do not conform to the requirements of default standard for bacterial endotoxin (Ph. Eur. 2.6.14 and 5.1.10) in that the products do not comply with the monograph endotoxin limit of ≤ 100 IU/mL. | The products to which this consent applies are those specified in the request submitted (ARTG 132680 and 132725). | Import and supply | Prescription medicines | |
| ALUSTAL HOUSE DUST MITES EXTRACT MAINTENANCE european house dust mite and american house dust mite 10.0 IR/mL injection suspension vial | Stallergenes Australia Pty Ltd | 132680 | CON-900 | The consent is effective from 18 January 2022 until further notice. | 18/01/2022 | Default standard for bacterial endotoxin (Ph. Eur. 2.6.14 and 5.1.10) | The products do not conform to the requirements of default standard for bacterial endotoxin (Ph. Eur. 2.6.14 and 5.1.10) in that the products do not comply with the monograph endotoxin limit of ≤ 100 IU/mL. | The products to which this consent applies are those specified in the request submitted (ARTG 132680 and 132725). | Import and supply | Prescription medicines | |
| CARDIOLITE kit for preparation of technetium (99mTc) sestamibi injection vial | GMS Australia Pty Limited TA Radpharm Scientific | 49688 | CON-899 | The consent is effective for all relevant batches released from 20 December 2021 until 30 June 2022. | 20/12/2021 | Paragraph 8(1)(i), paragraphs 9(1)(b)-(g), subsection 9(3), subsection 9(5) and paragraphs 10(4)(c)-(k) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The product does not conform to the requirements of paragraph 8(1)(i), paragraphs 9(1)(b)-(g), subsection 9(3), subsection 9(5) and paragraphs 10(4)(c)-(k) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the product does not state the information on the main label and vial label as required by TGO 91, does not include the name and address of the current sponsor, and does not state the active ingredient name in accordance with the current Australian Approved Name. | 1. The affected batches to which this consent applies are printed with the labels provided under Module 1.3.3.3 mockup-approved in the application dated 16 June 2020. 2. The above labels are over-labelled with the current sponsor details. | Import and supply | Prescription medicines | |
| DEFINITY perflutren lipid microsphere injection vial | GMS Australia Pty Limited TA Radpharm Scientific | 124808 | CON-898 | The consent is effective from 20 December 2021 until 30 June 2022. | 20/12/2021 | Paragraphs 9(1)(b)-(g), subsection 9(3), subsection 9(5) and paragraphs 10(4)(c)-(k) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The product does not conform to the requirements of paragraphs 9(1)(b)-(g), subsection 9(3), subsection 9(5) and paragraphs 10(4)(c)-(k) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the product does not state the information on the carton main label and vial label as required by TGO 91, does not satisfy the formatting of text on the vial label as required by TGO 91 and does not state the active ingredient name in accordance with the current Australian Approved Name. | 1. The affected batches to which this consent applies are printed with the labels provided under Module 1.3.3.3 mockup-approved in the application dated 12 June 2020. 2. The above labels are over-labelled with the current sponsor details. | Import and supply | Prescription medicines | |
| SEED PHARMA CARBIMAZOLE 5 carbimazole 5 mg tablet blister pack | Seed Pharma Pty Ltd | 349097 | 200328, 200329A, 210029, 210030, 210031, 210033, 210035, 210132, 210133, 210134, 210034, and 200337 | CON-897 | The consent is effective from 17 December 2021 until 31 March 2023 or until the stock is exhausted. | 17/12/2021 | Subparagraphs 10(14)(a)(iv) and (ix) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product does not conform to the requirements of subparagraphs 10(14)(a)(iv) and (ix) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines in that the blister foils do not state the name of the medicine and the name or an identifier of the sponsor. | 1. The blister labels to which this consent applies are those provided with the application and packaged in the Australian approved carton labels as agreed with the TGA on 26 November 2021. 2. A 'Dear Pharmacist' letter identical to that agreed with the TGA on 7 December 2021 advising them to remind patients to keep the blister packs with the correctly labelled carton, must be provided with each of the affected batches. | Supply | Prescription medicines |
| NUVARING etonogestrel 11.7 mg and ethinylestradiol 2.7 mg vaginal drug delivery system | Organon Pharma Pty Ltd | 96229 | U008243 | CON-896 | The consent is effective for the aforementioned batches only from 16 December 2021 until 31 July 2022. | 16/12/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The packaging does not conform with the requirements of paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd). | Import and supply | Prescription medicines | |
| ARCOXIA etoricoxib 120 mg tablet blister pack | Organon Pharma Pty Ltd | 81458 | U017021 | CON-896 | The consent is effective for the aforementioned batches only from 16 December 2021 until 31 July 2022. | 16/12/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The packaging does not conform with the requirements of paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd). | Import and supply | Prescription medicines | |
| LIVIAL tibolone 2.5 mg tablet blister pack | Organon Pharma Pty Ltd | 55088 | T042948 and U025299 | CON-896 | The consent is effective for the aforementioned batches only from 16 December 2021 until 31 July 2022. | 16/12/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The packaging does not conform with the requirements of paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd). | Import and supply | Prescription medicines | |
| PROSCAR finasteride 5mg tablet, blister pack | Organon Pharma Pty Ltd | 43667 | U014506 and U024103 | CON-896 | The consent is effective for the aforementioned batches only from 16 December 2021 until 31 July 2022. | 16/12/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The packaging does not conform with the requirements of paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd). | Import and supply | Prescription medicines | |
| DIPROSONE OV betamethasone 0.5 mg/g (as dipropionate) ointment tube | Organon Pharma Pty Ltd | 18823 | U002587 | CON-896 | The consent is effective for the aforementioned batches only from 16 December 2021 until 31 July 2022. | 16/12/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The packaging does not conform with the requirements of paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd). | Import and supply | Prescription medicines | |
| DIPROSONE betamethasone 0.5 mg/g (as dipropionate) ointment tube | Organon Pharma Pty Ltd | 144098 | T042706 | CON-896 | The consent is effective for the aforementioned batches only from 16 December 2021 until 31 July 2022. | 16/12/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The packaging does not conform with the requirements of paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd). | Import and supply | Prescription medicines | |
| ALUNBRIG brigatinib 90 mg film-coated tablet blister pack | Takeda Pharmaceuticals Australia Pty Ltd | 299968 | 21711 | CON-895 | The consent is effective for the aforementioned batches only from 16 December 2021 until 31 January 2024. | 16/12/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with the requirements of paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the products do not include the current address of the sponsor. | Supply | Prescription medicines | |
| ALUNBRIG brigatinib 90 mg and 180 mg film-coated tablets blister pack | Takeda Pharmaceuticals Australia Pty Ltd | 299966 | 020846, 021779 and 022022 | CON-895 | The consent is effective for the aforementioned batches only from 16 December 2021 until 31 January 2024. | 16/12/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with the requirements of paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the products do not include the current address of the sponsor. | Supply | Prescription medicines | |
| ALUNBRIG brigatinib 30 mg film-coated tablet blister pack | Takeda Pharmaceuticals Australia Pty Ltd | 299965 | 020418 and 021707 | CON-895 | The consent is effective for the aforementioned batches only from 16 December 2021 until 31 January 2024. | 16/12/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with the requirements of paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the products do not include the current address of the sponsor. | Supply | Prescription medicines | |
| ALUNBRIG brigatinib 180 mg film-coated tablet blister pack | Takeda Pharmaceuticals Australia Pty Ltd | 299964 | 021270, 021735 and 021974 | CON-895 | The consent is effective for the aforementioned batches only from 16 December 2021 until 31 January 2024. | 16/12/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with the requirements of paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the products do not include the current address of the sponsor. | Supply | Prescription medicines | |
| NESINA MET 12.5/500; 12.5 mg alogliptin (as benzoate) / 500 mg metformin hydrochloride film-coated tablets blister pack | Takeda Pharmaceuticals Australia Pty Ltd | 202308 | 11996446 | CON-895 | The consent is effective for the aforementioned batches only from 16 December 2021 until 31 January 2024. | 16/12/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with the requirements of paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the products do not include the current address of the sponsor. | Supply | Prescription medicines | |
| SALBUTAMOL CIPLA salbutamol 5 mg/2.5 mL (as sulfate) inhalation ampoules | Cipla Australia Pty Ltd | 115657 | IA10660 and IA10661 | CON-894 | The consent is effective for the listed batches from 16 December 2021 until 26 October 2023. | 16/12/2021 | Paragraph 9(3)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The products do not conform to the requirements of paragraph 9(3)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91), in that the labels do not include the name and quantity of the active ingredient together on one line immediately below the medicine name on the main label. | The labels to which this consent applies are those provided with the application and email correspondence dated 26 October 2021. | Supply | Prescription medicines |
| SALBUTAMOL CIPLA salbutamol 2.5 mg/2.5 mL (as sulfate) inhalation ampoules | Cipla Australia Pty Ltd | 115652 | IA00625, IA00626, IA00630, IA00631, IA00632, IA00655 and IA00656 | CON-894 | The consent is effective for the listed batches from 16 December 2021 until 26 October 2023. | 16/12/2021 | Paragraph 9(3)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The products do not conform to the requirements of paragraph 9(3)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91), in that the labels do not include the name and quantity of the active ingredient together on one line immediately below the medicine name on the main label. | The labels to which this consent applies are those provided with the application and email correspondence dated 26 October 2021. | Supply | Prescription medicines |
| SPORANOX itraconazole 10 mg/mL oral liquid bottle | Janssen-Cilag Pty Ltd | 62008 | CON-892 | The consent is effective for all relevant batches released from 10 September 2021 until 31 July 2022. | 10/12/2021 | Paragraph 8(1)(j) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The product does not conform to the requirements of paragraph 8(1)(j) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the product does not declare the presence of sugar alcohols on carton and bottle labels in the format required by Schedule 1 of TGO 91. | Import and supply | Prescription medicines | ||
| SPIKEVAX (elasomeran) COVID-19 VACCINE 0.2 mg/mL suspension for injection vial | Moderna Australia Pty Ltd | 370599 | CON-891 | The consent is effective from 10 December 2021 until 9 August 2023. | 10/12/2021 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The labels of the product do not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | The product must be supplied with the labels that were considered and agreed to as part of the evaluation of the application dated 6 December 2021, associated email correspondence, and mock-up labels under subsection 9D(3) of the Therapeutic Goods Act 1989, being Samsung labels - batches R1_V7 Vial and R1_V6 Carton. Pandemic Pack 2.0 labels - batches R2_V3 Vial and R2_V3 Carton. | Import and supply | Prescription medicines | |
| COMIRNATY (tozinameran [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial | Pfizer Australia Pty Ltd | 346290 | CON-890 | The consent is effective from 6 December 2021 until 24 January 2023. | 6/12/2021 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product does not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | The product must be supplied with the labels that were considered and agreed to as part of the evaluation of the application dated 1 November 2021, associated email correspondence, and mock-up labels under subsection 9D(3) of the Therapeutic Goods Act 1989, being EU Labels - batches PAA182622 and PAA182621. | Supply | Prescription medicines | |
| CANESORAL DUO fluconazole 150mg capsule blister pack and clotrimazole 10mg/g cream tube composite pack | Bayer Australia Ltd | 203513 | AUD012, AUD013 and AUD014 | CON-889 | The consent is effective from 6 December 2021 until 31 July 2022. | 6/12/2021 | Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines | The product does not fully conform to the requirements of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines. The tube label and the inner carton label for clotrimazole cream are not compliant with the requirements of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines but are compliant with the requirements of Therapeutic Goods Order No. 69 – General requirements for labels for medicines. | This consent only applies to batches AUD012, AUD013, and AUD014 | Import and supply | Over-the-counter medicines |
| NEUROLITE bicisate dihydrochloride 0.9 mg/mL kit for the preparation of technetium [99Tc] bicisate injection vial composite pack | Global Medical Solutions Australia Pty Limited TA Radpharm Scientific | 73014 | CON-888 | The consent is effective from 6 December 2021 until 30 June 2022. | 6/12/2021 | Paragraph 8(1)(i), paragraphs 9(1)(b)-(g), subsection 9(3), subsection 9(5) and paragraphs 10(4)(c)-(k) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The product does not conform to the requirements of paragraph 8(1)(i), paragraphs 9(1)(b)-(g), subsection 9(3), subsection 9(5) and paragraphs 10(4)(c)-(k) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the product does not state the information on the main label and vial label as required by TGO 91, does not include the name and address of the current sponsor, and does not state the active ingredient name in accordance with the current Australian Approved Name. | 1. The affected batches to which this consent applies are printed with the labels provided under Module 1.3.3.3 mockup-approved in the application dated 18 June 2020. 2. The above labels are over-labelled with the current sponsor details. | Import and supply | Prescription medicines | |
| COMIRNATY (Tozinameran [mRNA]) COVID-19 VACCINE 10 micrograms/0.2 mL concentrated suspension for injection vial | Pfizer Australia Pty Ltd | 377111 | CON-887 | The consent is effective from 6 December 2021 until 3 December 2023. | 6/12/2021 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The products do not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | The products must be supplied with the labels that were considered and agreed to as part of the evaluation of the application dated 15 November 2021, associated email correspondence, and mock-up labels under section 25 of the Therapeutic Goods Act 1989, being * EU Labels - batches PAA173907, PAA173908, PAA181915, PAA181046, PAA180830, PAA181041, PAA181770, PAA181911, PAA181047, PAA181044, PAA181045. * US Emergency Use Labels - batches PAA177913, PAA178418, PAA178420. NOTE US Emergency Use Labels do not have the tradename (COMIRNATY), generic name (tozinameran) or expiration date printed on the vial and/or carton labels. Determining the actual expiry date of any vaccine supplied with these labels will require the QR code on the carton to be scanned, followed by navigation to the page containing the expiry information. | Supply | Prescription medicines | |
| COMIRNATY (Tozinameran [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL suspension for injection vial | Pfizer Australia Pty Ltd | 377110 | CON-887 | The consent is effective from 6 December 2021 until 3 December 2023. | 6/12/2021 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The products do not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | The products must be supplied with the labels that were considered and agreed to as part of the evaluation of the application dated 15 November 2021, associated email correspondence, and mock-up labels under section 25 of the Therapeutic Goods Act 1989, being * EU Labels - batches PAA173907, PAA173908, PAA181915, PAA181046, PAA180830, PAA181041, PAA181770, PAA181911, PAA181047, PAA181044, PAA181045. * US Emergency Use Labels - batches PAA177913, PAA178418, PAA178420. NOTE US Emergency Use Labels do not have the tradename (COMIRNATY), generic name (tozinameran) or expiration date printed on the vial and/or carton labels. Determining the actual expiry date of any vaccine supplied with these labels will require the QR code on the carton to be scanned, followed by navigation to the page containing the expiry information. | Supply | Prescription medicines | |
| JURNISTA hydromorphone hydrochloride 4 mg prolonged release tablet blister pack | Janssen-Cilag Pty Ltd | 155995 | CON-886 | The consent is effective from 26 November 2021 until 30 June 2022. | 26/11/2021 | Paragraph 8(1)(b) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not conform to the requirements of paragraph 8(1)(b) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines, in that the products active ingredient name is misspelled on one carton panel. | Import and supply | Prescription medicines | ||
| JURNISTA hydromorphone hydrochloride 64 mg prolonged release tablet blister pack | Janssen-Cilag Pty Ltd | 141535 | CON-886 | The consent is effective from 26 November 2021 until 30 June 2022. | 26/11/2021 | Paragraph 8(1)(b) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not conform to the requirements of paragraph 8(1)(b) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines, in that the products active ingredient name is misspelled on one carton panel. | Import and supply | Prescription medicines | ||
| JURNISTA hydromorphone hydrochloride 32 mg prolonged release tablet blister pack | Janssen-Cilag Pty Ltd | 141534 | CON-886 | The consent is effective from 26 November 2021 until 30 June 2022. | 26/11/2021 | Paragraph 8(1)(b) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not conform to the requirements of paragraph 8(1)(b) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines, in that the products active ingredient name is misspelled on one carton panel. | Import and supply | Prescription medicines | ||
| JURNISTA hydromorphone hydrochloride 16 mg prolonged release tablet blister pack | Janssen-Cilag Pty Ltd | 141533 | CON-886 | The consent is effective from 26 November 2021 until 30 June 2022. | 26/11/2021 | Paragraph 8(1)(b) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not conform to the requirements of paragraph 8(1)(b) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines, in that the products active ingredient name is misspelled on one carton panel. | Import and supply | Prescription medicines | ||
| JURNISTA hydromorphone hydrochloride 8 mg prolonged release tablet blister pack | Janssen-Cilag Pty Ltd | 141508 | CON-886 | The consent is effective from 26 November 2021 until 30 June 2022. | 26/11/2021 | Paragraph 8(1)(b) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The products do not conform to the requirements of paragraph 8(1)(b) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines, in that the products active ingredient name is misspelled on one carton panel. | Import and supply | Prescription medicines | ||
| OTRIVIN PLUS nasal spray pump actuated metered dose aerosol | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 178401 | CON-885 | The consent is effective from 25 November 2021 until 26 November 2023. | 25/11/2021 | Subparagraph 11(2)(f)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92) | The products do not conform to the requirements of subparagraph 11(2)(f)(i) of Therapeutic Goods Order No. 92 Standard for labels of non-prescription medicines (TGO 92) in that the medicine labels express the quantity of the active ingredient as weight per volume instead of quantity delivered per actuation. | Import and supply | Other therapeutic goods registered | ||
| OTRIVIN MENTHOL ADULT NASAL SPRAY xylometazoline hydrochloride 1 mg/mL pump actuated metered dose aerosol bottle | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 99690 | CON-885 | The consent is effective from 25 November 2021 until 26 November 2023. | 25/11/2021 | Subparagraph 11(2)(f)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92) | The products do not conform to the requirements of subparagraph 11(2)(f)(i) of Therapeutic Goods Order No. 92 Standard for labels of non-prescription medicines (TGO 92) in that the medicine labels express the quantity of the active ingredient as weight per volume instead of quantity delivered per actuation. | Import and supply | Other therapeutic goods registered | ||
| OTRIVIN JUNIOR xylometazoline hydrochloride 0.5 mg/mL nasal spray pump actuated metered dose aerosol | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 142227 | CON-885 | The consent is effective from 25 November 2021 until 26 November 2023. | 25/11/2021 | Subparagraph 11(2)(f)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92) | The products do not conform to the requirements of subparagraph 11(2)(f)(i) of Therapeutic Goods Order No. 92 Standard for labels of non-prescription medicines (TGO 92) in that the medicine labels express the quantity of the active ingredient as weight per volume instead of quantity delivered per actuation. | Import and supply | Other therapeutic goods registered | ||
| OTRIVIN ADULT NASAL SPRAY xylometazoline hydrochloride 1 mg/mL pump actuated metered dose aerosol (reformulation) | GlaxoSmithKline Consumer Healthcare Australia Pty Ltd | 142197 | CON-885 | The consent is effective from 25 November 2021 until 26 November 2023. | 25/11/2021 | Subparagraph 11(2)(f)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92) | The products do not conform to the requirements of subparagraph 11(2)(f)(i) of Therapeutic Goods Order No. 92 Standard for labels of non-prescription medicines (TGO 92) in that the medicine labels express the quantity of the active ingredient as weight per volume instead of quantity delivered per actuation. | Import and supply | Other therapeutic goods registered | ||
| Elevit Pre-conception and Pregnancy | Bayer Australia Ltd | 377576 | CON-884 | The consent is effective from 23 November 2021. | 23/11/2021 | Subsections 17(1) and 20(a) of Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 | The Medicine does not conform to the requirements stated in subsections 17(1) and 20(a) of Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 in thatSubsection 17(1) - Dissolution testing of all actives. The proposed tests and limits as below Dissolution testing of all actives to be replaced with dissolution testing for folic acid, riboflavin (index vitamin) and iron (index mineral) as per Disintegration and dissolution of dietary supplements of the United States Pharmacopeia-National Formulary, Dietary Supplement Chapter lt;2040gt;Subsection 20(a) - Uniformity of dosage units. The proposed tests and limits as below Uniformity of mass as per Appendix XII C. Consistency of formulated preparations of the BP - Uniformity of mass (Ph.Eur.2.9.5) | * The goods are not required to comply with subsection 17(1) of the TGO 101 but must comply with the dissolution requirements of the United StatesPharmacopeia-National Formulary, Dietary Supplement Chapter lt;2040gt;‘Disintegration and Dissolution of Dietary Supplements’ for folic acid,riboflavin (index vitamin) and iron (index mineral); * The goods are not required to comply with subsection 20(a) of the TGO 101 but must comply with the requirements of the Appendix XII C. Consistency offormulated preparations of the BP - Uniformity of Weight (mass), Ph. Eur.method 2.9.5. | Import and supply | Registered complementary medicines | |
| ENSTILAR calcipotriol (as monohydrate) 50 microgram/g and betamethasone (as dipropionate) 500 microgram/g foam aerosol can | LEO Pharma Pty Ltd | 263292 | CON-883 | The consent is effective for all relevant batches released from 22 November 2021 until 1 November 2023. | 22/11/2021 | Paragraphs 8(1)(f-g) of Therapeutic Goods Order No. 91 Standard for labels of prescription and related medicines | The product does not conform to the requirements of paragraphs 8(1)(f-g) of Therapeutic Goods Order No. 91 Standard for labels of prescription and related medicines, in that the product does not include batch number and expiry date prefixes immediately preceding the batch number and expiry date printed on the bottom of the can. | Import and supply | Prescription medicines | ||
| ARCOXIA etoricoxib 60mg tablet blister pack | Organon Pharma Pty Ltd | 81456 | CON-882 | The consent is effective for all batches of the products released from the 9 November 2021 until 30 June 2022. | 9/11/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with the requirement of Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd). | Import and supply | Prescription medicines | ||
| NASONEX aqueous nasal spray mometasone furoate 50 microgram/actuation (as monohydrate) spray bottle | Organon Pharma Pty Ltd | 77112 | CON-882 | The consent is effective for all batches of the products released from the 9 November 2021 until 30 June 2022. | 9/11/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with the requirement of Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd). | Import and supply | Prescription medicines | ||
| IMPLANON NXT etonogestrel 68mg subcutaneous implant blister pack | Organon Pharma Pty Ltd | 198455 | CON-882 | The consent is effective for all batches of the products released from the 9 November 2021 until 30 June 2022. | 9/11/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with the requirement of Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd). | Import and supply | Prescription medicines | ||
| SAPHRIS asenapine (as maleate) 5mg sublingual wafer blister pack | Organon Pharma Pty Ltd | 166562 | CON-882 | The consent is effective for all batches of the products released from the 9 November 2021 until 30 June 2022. | 9/11/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with the requirement of Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd). | Import and supply | Prescription medicines | ||
| ARCOXIA etoricoxib 30mg tablet blister pack | Organon Pharma Pty Ltd | 131797 | CON-882 | The consent is effective for all batches of the products released from the 9 November 2021 until 30 June 2022. | 9/11/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The products do not conform with the requirement of Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd). | Import and supply | Prescription medicines | ||
| All blood components as per the Lifeblood Technical Master File | Australian Red Cross Lifeblood | CON-912 | The consent is effective from 5 November 2021 until 9 November 2022. | 5/11/2021 | Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019 / Council of Europe Guide to the Preparation, Use and Quality Assurance of Blood Components 19th edition | Blood components as per the Lifeblood Technical Master File do not conform to the donor haemoglobin requirements of Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019 / Council of Europe Guide to the Preparation, Use and Quality Assurance of Blood Components 19th edition, in that the current Hb limits are below CoE standards for whole blood and apheresis donors. | A condition of the exemption is that during the exemption Lifeblood will submit to Therapeutic Goods Administration a detailed proposal for the management of donor Hb and ferritin levels and provide data from preliminary studies as it becomes available. | Supply | Blood, tissues, and biologicals | ||
| SMOFKABIVEN amino acids 5.1% / lipids 3.8% / glucose 12.7% / electrolytes 0.7% emulsion for intravenous infusion bag 1970 mL | Fresenius Kabi Australia Pty Ltd | 180546 | 10QE6318 | CON-881 | The consent is effective from 28 October 2021 until the batch number 10QE6318 has expired (30 April 2023) or until the batch is depleted, whichever is sooner. | 28/10/2021 | Paragraphs 8(1)(i), 8(1)(n), 10(2)(a), 10(2)(f), 10(6)(b) and 10(6)(c) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product does not conform with the requirements of the paragraphs 8(1)(i), 8(1)(n), 10(2)(a), 10(2)(f), 10(6)(b) and 10(6)(c) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines the requirements of in that The name and contact details of the Australian sponsor or distributor are not included; There is no machine-readable code on the primary pack label; The quantity of each excipient in the stated volume of fill of the injection in the container is not listed; The statements use in one patient on one occasion only. Contains no antimicrobial preservative are not included; There is no statement specifying the injection is hypertonic; The statement of energy equivalent is not stated in kilojoules. | 1. Supply and use of this batch are restricted to the circumstances proposed in the application (use in compounding facilities only). 2. The affected batch will be labelled with the 'English neutral label'. 3. The AUST R will be over-stickered on the carton. 4. The receiving manufacturers will be advised of the situation and will be instructed to keep the bags in the cartons labelled with the AUST R number until required for use. | Import and supply | Prescription medicines |
| Caruso's GET UP GO | Caruso's Natural Health Pty Ltd | 370762 | CON-880 | The consent is effective from the 22 October 2021 until 1 September 2022. | 22/10/2021 | Subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of Subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the name of the medicine on the main label is not presented in a continuous, uninterrupted manner and is broken up by additional information and graphics. | Supply | Listed complementary medicines | ||
| Caruso's WEE LESS | Caruso's Natural Health Pty Ltd | 370815 | CON-880 | The consent is effective from the 22 October 2021 until 1 September 2022. | 22/10/2021 | Subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of Subsection 9(2) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the name of the medicine on the main label is not presented in a continuous, uninterrupted manner and is broken up by additional information and graphics. | Supply | Listed complementary medicines | ||
| OZURDEX dexamethasone 700 microgram intravitreal implant | Allergan Australia Pty Ltd | 222392 | CON-879 | The consent is effective from 20 October 2021 until 31 October 2023. | 20/10/2021 | Paragraph 9(3)(a) and Subsection 9(5) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The product does not conform to the requirements of Paragraph 9(3)(a) and Subsection 9(5) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the product does not have the name and quantity of the active ingredient printed immediately below the name of the medicine on the applicator pen label, and are printed in a text size less than 3.0 millimetres in size. | Import and supply | Prescription medicines | ||
| JESPECT japanese encephalitis virus purified inactivated vaccine 0.5mL suspension for injection syringe | Seqirus Pty Limited | 150602 | JEV19F14D (4311 doses) and JEV19J25D (4545 doses) | CON-878 | The consent is effective from 19 October 2021 until the proposed amended expiry dates (30/09/2022 for batch JEV19F14D and 28/02/2023 for batch JEV19J25D) or until the batches are depleted. | 19/10/2021 | Paragraphs 8(3)(e) and 10(5)(f) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The product packaging does not conform with the requirements of Paragraphs 8(3)(e) and 10(5)(f) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the carton, blister tray and syringe labels include an incorrect expiry date. | 1. A ‘Dear Immuniser’ letter (as per the copy provided with the application from Seqirus Pty Limited) will be supplied with each unit in the affected batches outlining the non-compliance in the product labelling (discrepancy in expiry dates). 2. An explanatory letter to customers (i.e. wholesalers and pharmacists), as per the copy provided with the application from Seqirus Pty Limited, detailing the proposed changes, providing directions on where further information can be obtained (e.g. websites) and how replacement product can be obtained, will be distributed. 3. Over-labelling will be performed at a registered secondary packaging site for the carton labels to include the correct expiry date. 4. A record of maintenance of the approved storage conditions for Jespect (i.e. 2℃ to 8℃) during the over-labelling process, including transport, will be provided to TGA as per the email from Seqirus Pty Limited dated 19 October 2021. | Supply and export | Prescription medicines |
| Pfizer (Australia) STERILE POTASSIUM CHLORIDE CONCENTRATE potassium chloride 750 mg/10 mL injection ampoule | Pfizer Australia Pty Ltd | 10793 | CON-877 | The consent is effective for all batches of the product released for supply from 18 October 2021 until 18 October 2023. | 18/10/2021 | Paragraph 11(2)(f) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The product does not conform with the requirements of Paragraph 11(2)(f) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the carton label for the product states the strength of the active ingredient as 10mmol (0.75g) in 10mL. | The carton label to which this consent applies is that provided with the application in the email correspondence from Pfizer Australia Pty Ltd to the TGA dated 8th October 2021. | Supply | Prescription medicines | |
| ENTRESTO 49/51 sacubitril/valsartan (combined as a sodium salt hydrate complex) 48.6/51.4 mg film-coated tablet blister pack | Novartis Pharmaceuticals Australia Pty Ltd | 234222 | CON-876 | The consent is effective from 18 October 2021 for all batches released for supply until 31 October 2022. | 18/10/2021 | Paragraph 10(10)(a) and Paragraph 10(14)(a) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The product(s) do not conform to the requirements of Paragraph 10(10)(a) and Paragraph 10(14)(a) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the product(s) sample pack carton labels do not include a space for the prescriber to provide dispensing details and the batch number/expiry date prefixes on blister foil labels do not precede the batch number/expiry date. | 1. The product labels to which this consent applies are those provided with the application from Novartis Pharmaceuticals Australia Pty Ltd dated 23 February 2021. | Import and supply | Prescription medicines | |
| ENTRESTO 24/26 sacubitril/valsartan (combined as a sodium salt hydrate complex) 24.3/25.7 mg film-coated tablet blister pack | Novartis Pharmaceuticals Australia Pty Ltd | 234219 | CON-876 | The consent is effective from 18 October 2021 for all batches released for supply until 31 October 2022. | 18/10/2021 | Paragraph 10(10)(a) and Paragraph 10(14)(a) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The product(s) do not conform to the requirements of Paragraph 10(10)(a) and Paragraph 10(14)(a) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the product(s) sample pack carton labels do not include a space for the prescriber to provide dispensing details and the batch number/expiry date prefixes on blister foil labels do not precede the batch number/expiry date. | 1. The product labels to which this consent applies are those provided with the application from Novartis Pharmaceuticals Australia Pty Ltd dated 23 February 2021. | Import and supply | Prescription medicines | |
| ENTRESTO 97/103 sacubitril/valsartan (combined as a sodium salt hydrate complex) 97.2/102.8 mg film-coated tablet blister pack | Novartis Pharmaceuticals Australia Pty Ltd | 234218 | CON-876 | The consent is effective from 18 October 2021 for all batches released for supply until 31 October 2022. | 18/10/2021 | Paragraph 10(10)(a) and Paragraph 10(14)(a) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The product(s) do not conform to the requirements of Paragraph 10(10)(a) and Paragraph 10(14)(a) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the product(s) sample pack carton labels do not include a space for the prescriber to provide dispensing details and the batch number/expiry date prefixes on blister foil labels do not precede the batch number/expiry date. | 1. The product labels to which this consent applies are those provided with the application from Novartis Pharmaceuticals Australia Pty Ltd dated 23 February 2021. | Import and supply | Prescription medicines | |
| ANTROQUORIL betamethasone 0.2mg/g (as valerate) cream tube | Organon Pharma Pty Ltd | 70406 | B55001, B55301, B59801, B59501, B59601, B62801, B59701, B63001, B62901, B63101, B69101, B68901, B69001 | CON-875 | The consent is effective from 15 October 2021 until 30 May 2022. | 15/10/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The product(s) do not conform to the requirements of Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the product(s) labels do not include the current sponsor details (Organon Pharma Pty Ltd). | Supply | Prescription medicines | |
| CELESTONE-M betamethasone 0.2mg/g (as valerate) cream tube | Organon Pharma Pty Ltd | 18778 | B54901, B62701, B68701, B68801 | CON-875 | The consent is effective from 15 October 2021 until 30 May 2022. | 15/10/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The product(s) do not conform to the requirements of Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the product(s) labels do not include the current sponsor details (Organon Pharma Pty Ltd). | Supply | Prescription medicines | |
| XEVUDY sotrovimab 500 mg/8 mL concentrated injection solution for infusion, vial | GlaxoSmithKline Australia Pty Ltd | 364110 | CON-874 | The consent is effective from the 15th October 2021 until 17 August 2023. | 15/10/2021 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product does not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines, in that key relevant information (as would be required under TGO 91) is absent from the labels. | Import and supply | Prescription medicines | ||
| ROPIVACAINE READYFUSOR ropivacaine hydrochloride 0.2% solution for injection, bottle in dispenser device | BioQ Pharma Pty Ltd | 267572 | CON-873 | The consent is effective from 14 October 2021 until 13 October 2022. | 14/10/2021 | Subsections 7(2) and 9(5), and subparagraphs 9(3)(a)(i) and 9(1)(f)(i), of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product does not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines, in that the product label does not have text at the minimum height required, does not include the name and quantity of the active ingredient immediately below the name of the product on the main panel, and does not include the approved route of administration on the main panel. | Import and supply | Prescription medicines | ||
| Pfizer (Australia) STERILE POTASSIUM CHLORIDE CONCENTRATE potassium chloride 750 mg/10 mL injection ampoule | Pfizer Australia Pty Ltd | 10793 | B699, B723, B764, B765, B708 | CON-872 | The consent is effective from the 6 October 2021 until 7 October 2022. | 6/10/2021 | Paragraph 11(2)(f) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The product does not conform with the requirements of Paragraph 11(2)(f) of TGO 91 in that the carton label does not state the weight of the active ingredient in the stated volume of fill of the injection in the container. | A Customer letter identical to that provided to the Therapeutic Goods Administration on 29 September 2021 will be supplied with each affected batch. | Supply | Prescription medicines |
| RAPIVAB peramivir 200 mg / 20 mL concentrate for intravenous infusion glass vial | Biocelect Pty Ltd | 285559 | C2000129 | CON-870 | The consent is effective for batch number C2000129 of the product from 27 September 2021 until 27 September 2026, or until the batch is depleted, whichever is sooner. | 27/09/2021 | Paragraphs 8(1)(d), 8(1)(f), 8(1)(g), 8(1)(h), 9(1)(g) and 9(3)(a); and Subparagraphs 10(3)(a)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The product does not conform with the requirements of Section 6 ‘main label’; Paragraphs 8(1)(d), 8(1)(f), 8(1)(g), 8(1)(h), 9(1)(g) and 9(3)(a); and Subparagraphs 10(3)(a)(i) of TGO 91 in that the product packaging does not comply with the following • The carton label does not include the medicine name more conspicuously on the main panel; does not include the approved name of the dosage form ‘Concentrated Injection’; does not indicate the location of the batch and expiry prefixes; does not include the statement ‘Protect from light’; does not include the words ‘for infusion’ adjacent to the name of the dosage form; does not include the name and quantity of the active ingredient together on one line immediately below the medicine name; and does not state the amount of the excipient ‘sodium chloride’ in the volume of fill of the injection in the container (i.e. 20 mL). • The vial label does not include the approved name of the dosage form ‘Concentrated Injection’; does not indicate the location of the batch and expiry prefixes; and does not include the statement ‘Protect from light’. | 1. A ‘Dear Healthcare Professional’ letter identical to that provided in the email correspondence to the Therapeutic Goods Administration dated 22 September 2021 will be supplied with each affected batch outlining the non-compliance in the product labelling. 2. The labels to which this consent applies are those provided in the email correspondence to the Therapeutic Goods Administration dated 22 September 2021 | Import and supply | Prescription medicines |
| VASOCARDOL CD diltiazem hydrochloride 360 mg capsule bottle | Sanofi-Aventis Australia Pty Ltd | 75253 | CON-871 | The consent is effective from the 24 September 2021 until 30 April 2022 | 24/09/2021 | subsection 17(2) of the Therapeutic Goods Order No. 101 - Standard for tablets, Capsules and Pills | The products that do not conform to the requirements of subsection 17(2) of the Therapeutic Goods Order No. 101 - Standard for Tablets, Capsules and Pills., in that the products do not meet the approved dissolution limits after long term storage. | The extent of the non-compliance is only as described in the application dated 9 September 2021. | Import and supply | Prescription medicines | |
| CARDIZEM CD diltiazem hydrochloride 360 mg capsule bottle | Sanofi-Aventis Australia Pty Ltd | 75251 | CON-871 | The consent is effective from the 24 September 2021 until 30 April 2022 | 24/09/2021 | subsection 17(2) of the Therapeutic Goods Order No. 101 - Standard for tablets, Capsules and Pills | The products that do not conform to the requirements of subsection 17(2) of the Therapeutic Goods Order No. 101 - Standard for Tablets, Capsules and Pills., in that the products do not meet the approved dissolution limits after long term storage. | The extent of the non-compliance is only as described in the application dated 9 September 2021. | Import and supply | Prescription medicines | |
| DILTIAZEM SANDOZ CD diltiazem hydrochloride 360 mg capsule bottle (unprinted) | Sanofi-Aventis Australia Pty Ltd | 131304 | CON-871 | The consent is effective from the 24 September 2021 until 30 April 2022 | 24/09/2021 | subsection 17(2) of the Therapeutic Goods Order No. 101 - Standard for tablets, Capsules and Pills | The products that do not conform to the requirements of subsection 17(2) of the Therapeutic Goods Order No. 101 - Standard for Tablets, Capsules and Pills., in that the products do not meet the approved dissolution limits after long term storage. | The extent of the non-compliance is only as described in the application dated 9 September 2021. | Import and supply | Prescription medicines | |
| RIZATRIPTAN WAFERS-10mg rizatriptan (as benzoate) 10mg wafer blister pack | Organon Pharma Pty Ltd | 225969 | CON-869 | The consent is effective for all batches of the products released from 24 September 2021 until 31 October 2023. | 24/09/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The product packaging does not conform with the requirement of Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd). | Import and supply | Prescription medicines | ||
| MAXALT rizatriptan (as benzoate) 10mg wafer blister pack | Organon Pharma Pty Ltd | 69076 | CON-869 | The consent is effective for all batches of the products released from 24 September 2021 until 31 October 2023. | 24/09/2021 | Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) | The product packaging does not conform with the requirement of Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd). | Import and supply | Prescription medicines | ||
| RIKODEINE 9.5 mg/5 mL oral liquid bottle | iNova Pharmaceuticals (Australia) Pty Limited | 10587 | 100ml pack size: batches 1092659, 1094828, 1094653, 1099003, 1105307 and 1106191. 200ml pack size: batches 1092292, 1091236, 1092658, 1094204, 1093782, 1094825, 1094827, 1094826, 1099004, 1099005, 1099006, 1099563, 1103712, 1104697, 1104696, 1105306, 1105859, 1106193, 1106192 and 1108040. | CON-868 | The consent is effective from 16 September 2021 until 31 July 2023. | 16/09/2021 | Subparagraph 11(1)(a)(v) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines | The product does not conform to the requirements of subparagraph 11(1)(a)(v) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines in that under the heading ‘Active ingredients per 10 mL’, the labels incorrectly state the quantity of sorbitol as “4.4 mg” when the correct unit of measure is “4.4 g”. | Supply | Over-the-counter medicines | |
| ACTEMRA tocilizumab (rch) 200 mg/10 mL injection concentrated vial | Roche Products Pty Ltd | 149404 | 1163406, 1164929, 1163292, 1163279, 1162729, 1163299, 1164608 and 1164287 | CON-867 | The consent is effective from 16 September 2021 until supply of the affected clinical trial labelled batches 1163406, 1164929, 1163292, 1163279, 1162729, 1163299, 1164608, and 1164287 is exhausted. | 16/09/2021 | Therapeutic Goods Order No. 91- Standard for labels of prescription and related medicines | The product does not conform to the requirements of Therapeutic Goods Order No. 91- Standard for labels of prescription and related medicines, in that the product is labelled for clinical trial use only as per Annex 13 of the PIC/S Guide to GMP (Investigational Medicinal Products) labelling requirements. | Information will be provided to the relevant healthcare professionals to confirm the product supplied is identical to Australian registered Actemra product and to explain the difference in product packaging compared to commercial product, | Import and supply | Prescription medicines |
| BiomeBoost Faecal Microbiota Transplant | BiomeBank | Batches BB165/167 | CON-866 | The consent is effective from 14 September 2021 until 31 October 2021. | 14/09/2021 | Subparagraphs 13(3)(a)(ii) and (iii), 13(3)(b)(ii) and (iii), paragraphs 13(4)(b) and (c) of Therapeutic Goods Order No. 105 - Standard for Faecal Microbiota Transplant Products | The product does not conform to the requirements of subparagraphs 13(3)(a)(ii) and (iii), 13(3)(b)(ii) and (iii), paragraphs 13(4)(b) and (c) of Therapeutic Goods Order No. 105 - Standard for Faecal Microbiota Transplant Products, in that blood and stool testing will not be collected as described for FMT products other than fresh FMT products. | It is a condition of approval that the product be administered only for the treatment of Clostridium difficile infection in the single patient specified in the application form, after obtaining informed consent. | Supply | Blood, tissues, and biologicals | |
| VEKLURY remdesivir 100 mg powder for injection vial | Gilead Sciences Pty Ltd | 338419 | 21090201M (28,000 units) | CON-864 | 13/09/2021 | Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) | The product does not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91). | 1. The labels to which this consent applies are those provided with the request, submitted 10 September 2021. 2. A ‘Medicines Fact Sheet’ will be supplied with the affected batch that will detail the appropriate use and storage of the product in accordance with the approved Australian Product Information (PI). | Import and supply | Prescription medicines | |
| RUZURGI amifampridine 10 mg tablet bottle | ORSPEC Pharma Pty Ltd | 352630 | CON-865 | The consent is effective from 10 September 2021 until 10 September 2023. | 10/09/2021 | Subsections 9(1), 9(2) and 9(3) of Therapeutic Goods Order No. 95 - Child‑resistant packaging requirements for medicines 2017 | The product does not conform to the requirements of subsections 9(1), 9(2) and 9(3) of Therapeutic Goods Order No. 95 - Child‑resistant packaging requirements for medicines 2017, in that testing of child resistance has not yet been completed and documented. | Import and supply | Prescription medicines | ||
| doTERRA Peppermint | dōTERRA Australia Pty Ltd | 332583 | CON-863 | The consent is effective from 9 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| doTERRA Bergamot | dōTERRA Australia Pty Ltd | 336053 | CON-863 | The consent is effective from 9 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| doTERRA Roman Chamomile | dōTERRA Australia Pty Ltd | 337232 | CON-863 | The consent is effective from 9 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| doTERRA Cardamom | dōTERRA Australia Pty Ltd | 335587 | CON-863 | The consent is effective from 9 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| doTERRA Clary Sage | dōTERRA Australia Pty Ltd | 337228 | CON-863 | The consent is effective from 9 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| doTERRA Cypress | dōTERRA Australia Pty Ltd | 338888 | CON-863 | The consent is effective from 9 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| doTERRA Marjoram | dōTERRA Australia Pty Ltd | 336054 | CON-863 | The consent is effective from 9 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| doTERRA Eucalyptus | dōTERRA Australia Pty Ltd | 336052 | CON-863 | The consent is effective from 9 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| doTERRA Fennel | dōTERRA Australia Pty Ltd | 335588 | CON-863 | The consent is effective from 9 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| doTERRA Litsea | dōTERRA Australia Pty Ltd | 338887 | CON-863 | The consent is effective from 9 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| BEXSERO - multi-component Meningococcal B vaccine (recombinant, adsorbed) suspension for injection 0.5 ml pre-filled syringe without needle | GlaxoSmithKline Australia Pty Ltd | 190718 | CON-862 | The consent is effective from 9 September 2021 until 23 July 2022. | 9/09/2021 | Paragraph 10(3)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines | The product does not comply with Paragraph 10(3)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines, in that the excipient name on the label, aluminium hydroxide, does not align with the Australian Approved Name (AAN), aluminium hydroxide hydrate. | 1. Non-compliance with Therapeutic Goods Order 91 (TGO 91) is limited to the information detailed in the submission. 2. The non-compliant label will be revised to become fully compliant with TGO 91 on or before 23 July 2022. 3. This exemption applies only to products released in the Australian market before 23 July 2022. | Import and supply | Prescription medicines | |
| NUTRIWAY* HERBALS BILBERRY LUTEIN BLEND. | Amway of Australia | 71319 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY GARLIC HEART CARE | Amway of Australia | 92128 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY OMEGA 3 COMPLEX | Amway of Australia | 82166 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY COMPLEX FOR HAIR SKIN AND NAILS DIETARY SUPPLEMENT | Amway of Australia | 80537 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY* HERBALS TRIPLE SHIELD* ECHINACEA DIETARYSUPPLEMENT | Amway of Australia | 78752 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY Tri-Iron Folic | Amway of Australia | 234661 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Nutriway Trim Choice Advance | Amway of Australia | 230849 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY Cal Mag D Advanced | Amway of Australia | 206345 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY VITAMIN C PLUS EXTENDED RELEASE | Amway of Australia | 174148 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY GLUCOSAMINE HCL WITH BOSWELLIA DIETARY SUPPLEMENT | Amway of Australia | 154934 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY DAILY MULTIVITAMIN MULTIMINERAL TABLET | Amway of Australia | 152479 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY FIBRE BLEND CHEWABLE TABLET | Amway of Australia | 145941 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY MILK THISTLE AND DANDELION DIETARY SUPPLEMENT | Amway of Australia | 120668 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY CARB BLOCKER PLUS HERBAL DIETARY SUPPLEMENT | Amway of Australia | 114288 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY CHOLESTEROL HEALTH GREEN TEA DIETARY SUPPLEMENT | Amway of Australia | 104714 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY PARSELENIUM-E | Amway of Australia | 77605 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY HERBALS SIBERIAN GINSENG GINKGO BILOBA BLEND HERBAL DIETARY SUPPLEMENT. | Amway of Australia | 59162 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY* Vitamin B Complete Dual Action tablet | Amway of Australia | 268592 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Xs ENERGISE RHODIOLA SUPPLEMENT | Amway of Australia | 266798 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRIWAY CONCENTRATED FRUITS AND VEGETABLES | Amway of Australia | 238532 | CON-861 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Thursday Plantation Tea Tree Cold Sore Cream tube | Integria Healthcare Australia Pty Ltd | 50564 | CON-857 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Registered complementary medicines | ||
| THURSDAY PLANTATION TEA TREE OIL Melaleuca Oil 1 mL/mL multipurpose liquid bottle | Integria Healthcare Australia Pty Ltd | 15674 | CON-857 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Registered complementary medicines | ||
| NUTRA-LIFE GUT RELIEF | Vitaco Health Australia Pty Ltd | 337425 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE LIVER GUARD 35,000 PLUS | Vitaco Health Australia Pty Ltd | 336523 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE BIO-CURCUMIN TURMERIC 16,500+ | Vitaco Health Australia Pty Ltd | 336668 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE COLD FLU IMMUNE SUPPORT | Vitaco Health Australia Pty Ltd | 336589 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE ESTER-C + PROBIOTICS | Vitaco Health Australia Pty Ltd | 324631 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE KYOLIC AGED GARLIC EXTRACT HEART CHOLESTEROL FORMULA | Vitaco Health Australia Pty Ltd | 335450 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE VITAMIN C 1200 mg CHEWABLES | Vitaco Health Australia Pty Ltd | 334202 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE CRANBERRY 50,000 | Vitaco Health Australia Pty Ltd | 329894 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE GRAPE SEED 50,000 + | Vitaco Health Australia Pty Ltd | 327877 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| UTRA-LIFE GREEN LIPPED MUSSEL 850 mg + | Vitaco Health Australia Pty Ltd | 327201 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE PROBIOTICA DAILY HEALTH | Vitaco Health Australia Pty Ltd | 325284 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE HERBAL Y EXTREME | Vitaco Health Australia Pty Ltd | 324743 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE ESTER-C + PROBIOTICS | Vitaco Health Australia Pty Ltd | 324631 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE PROBIOTICA MOOD BALANCE | Vitaco Health Australia Pty Ltd | 323803 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE PROBIOTICA HIGH POTENCY | Vitaco Health Australia Pty Ltd | 319650 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRALIFE MAGNESIUM STRESS EASE | Vitaco Health Australia Pty Ltd | 314025 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE MAGNESIUM HI-ZORB | Vitaco Health Australia Pty Ltd | 314035 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE MAGNESIUM COMPLETE FORTE | Vitaco Health Australia Pty Ltd | 314036 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE PROBIOTICA EXTRA CARE | Vitaco Health Australia Pty Ltd | 311717 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE SUPER B PLUS | Vitaco Health Australia Pty Ltd | 311315 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE BILBERRY 10,000 PLUS | Vitaco Health Australia Pty Ltd | 310442 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE PROSTATE COMPLETE | Vitaco Health Australia Pty Ltd | 308311 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE PROBIOTICA KID'S DAILY | Vitaco Health Australia Pty Ltd | 300534 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE SILICAPLEX 5000 | Vitaco Health Australia Pty Ltd | 289118 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE COQ10 300 mg | Vitaco Health Australia Pty Ltd | 286704 | CON-856 | The consent is effective from 2 September 2021 until 1 September 2022 | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Caruso’s Saffron | Caruso's Natural Health Pty Ltd | 296835 | CON-846 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Caruso’s Green Tea | Caruso's Natural Health Pty Ltd | 292329 | CON-846 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Caruso’s Cascara | Caruso's Natural Health Pty Ltd | 292328 | CON-846 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Caruso’s Super Collagen Builder | Caruso's Natural Health Pty Ltd | 260671 | CON-846 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Caruso’s Triple Strength Fish Oil | Caruso's Natural Health Pty Ltd | 345956 | CON-846 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Caruso’s Stress Clear | Caruso's Natural Health Pty Ltd | 215877 | CON-846 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Caruso’s Mega Memory | Caruso's Natural Health Pty Ltd | 206187 | CON-846 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Caruso’s Children’s Multivitamin | Caruso's Natural Health Pty Ltd | 346424 | CON-846 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Caruso’s Children’s Bone Health | Caruso's Natural Health Pty Ltd | 345959 | CON-846 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Caruso’s Children’s Brain Health | Caruso's Natural Health Pty Ltd | 345958 | CON-846 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Caruso’s Children’s Immune Health | Caruso's Natural Health Pty Ltd | 345960 | CON-846 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Caruso’s Children’s Eye Health | Caruso's Natural Health Pty Ltd | 344735 | CON-846 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Caruso’s Children’s Magnesium Complex | Caruso's Natural Health Pty Ltd | 341647 | CON-846 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Caruso's Boswellia 2500 | Caruso's Natural Health Pty Ltd | 315231 | CON-846 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Fish Oil 1500mg | Sanofi-Aventis Healthcare Pty Ltd | 267172 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| CENOVIS STRESS RELIEF | Sanofi-Aventis Healthcare Pty Ltd | 257313 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Iron Plus | Sanofi-Aventis Healthcare Pty Ltd | 265482 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Men's Multi | Sanofi-Aventis Healthcare Pty Ltd | 96028 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Women's Multi | Sanofi-Aventis Healthcare Pty Ltd | 318459 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Women's Multi + Energy Boost | Sanofi-Aventis Healthcare Pty Ltd | 322957 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Men's Multi + Performance | Sanofi-Aventis Healthcare Pty Ltd | 322406 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Hello Immunity | Sanofi-Aventis Healthcare Pty Ltd | 321105 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Hello Detox | Sanofi-Aventis Healthcare Pty Ltd | 321103 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Hello Energy | Sanofi-Aventis Healthcare Pty Ltd | 321104 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Hello Calm | Sanofi-Aventis Healthcare Pty Ltd | 321106 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Hello Focus | Sanofi-Aventis Healthcare Pty Ltd | 321109 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Hello Boost | Sanofi-Aventis Healthcare Pty Ltd | 320998 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Hair, Skin Nails | Sanofi-Aventis Healthcare Pty Ltd | 314234 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Cranberry 30,000 | Sanofi-Aventis Healthcare Pty Ltd | 257233 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Echinacea 5000 | Sanofi-Aventis Healthcare Pty Ltd | 248433 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Turmeric 3100 | Sanofi-Aventis Healthcare Pty Ltd | 237253 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Zinc Plus | Sanofi-Aventis Healthcare Pty Ltd | 236895 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Cold Sore Complex | Sanofi-Aventis Healthcare Pty Ltd | 235512 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| CENOVIS WOMEN’S MULTI | Sanofi-Aventis Healthcare Pty Ltd | 233655 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis 50+ Multi | Sanofi-Aventis Healthcare Pty Ltd | 233483 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Ginkgo Biloba 2000 | Sanofi-Aventis Healthcare Pty Ltd | 226980 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Co-Enzyme Q10 150 mg | Sanofi-Aventis Healthcare Pty Ltd | 223677 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Liver Support Milk Thistle 7000 | Sanofi-Aventis Healthcare Pty Ltd | 217877 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Guarana + Ginseng | Sanofi-Aventis Healthcare Pty Ltd | 217485 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Garlic | Sanofi-Aventis Healthcare Pty Ltd | 211990 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Men's Multi | Sanofi-Aventis Healthcare Pty Ltd | 196028 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| CENOVIS COD LIVER OIL | Sanofi-Aventis Healthcare Pty Ltd | 178615 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Mega C 1000 mg | Sanofi-Aventis Healthcare Pty Ltd | 67549 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Sugarless C 500 mg | Sanofi-Aventis Healthcare Pty Ltd | 55033 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| CENOVIS MEGA B | Sanofi-Aventis Healthcare Pty Ltd | 113019 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Echinacea, Garlic, Zinc C | Sanofi-Aventis Healthcare Pty Ltd | 147655 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Easy Sleep Valerian | Sanofi-Aventis Healthcare Pty Ltd | 214036 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Multivitamin and Minerals | Sanofi-Aventis Healthcare Pty Ltd | 172259 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Garlic and Horseradish + C Complex | Sanofi-Aventis Healthcare Pty Ltd | 242498 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Mega Calcium Plus D | Sanofi-Aventis Healthcare Pty Ltd | 167654 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Celery 2500 | Sanofi-Aventis Healthcare Pty Ltd | 245172 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Vitamin D3 1000IU | Sanofi-Aventis Healthcare Pty Ltd | 172889 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis St John’s Wort | Sanofi-Aventis Healthcare Pty Ltd | 128698 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Mega E 500IU | Sanofi-Aventis Healthcare Pty Ltd | 167100 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Magnesium | Sanofi-Aventis Healthcare Pty Ltd | 154312 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Vitamin C 250 mg | Sanofi-Aventis Healthcare Pty Ltd | 53666 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis Folic Acid 500 mcg | Sanofi-Aventis Healthcare Pty Ltd | 90869 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Cenovis B Complex | Sanofi-Aventis Healthcare Pty Ltd | 159721 | CON-843 | The consent is effective from 2 September 2021 until 1 September 2022. | 9/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| Wheyless Acetyl-L-Carnitine | Australian Health Vitality Pty Ltd | 339351 | CON-860 | The consent is effective from 2 September 2021 until 1 September 2022. | 2/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The product does not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the name of the medicine on the main label is not presented in a continuous, uninterrupted manner and is broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| ESTRADERM MX 100 estradiol 100 microgram/24 hours (3 mg) transdermal drug delivery system sachet | Juno Pharmaceuticals Pty Ltd | 67090 | 226420 | CON-859 | The consent is effective from 2 September 2021 until 31 March 2023 or until the batches are depleted. | 2/09/2021 | Section 6, and Paragraphs 8(1)(b), 8(1)(f), 8(1)(g), 8(1)(i), 9(3)(a) and 11(1)(b) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines | The product packaging does not conform with the requirements of Section 6 'name of an active ingredient'; and Paragraphs 8(1)(b), 8(1)(f), 8(1)(g), 8(1)(i), 9(3)(a) and 11(1)(b) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that The carton labels for the products do not include the Australian approved name for the active ingredient Estradiol ; do not include the Australian approved name for Estrogen ; the batch number and expiry date prefixes are not preceding the batch number and expiry date; do not include the current sponsor address and updated sponsor logo; do not include the name and quantity of the active ingredient on one line immediately underneath the medicine name; and includes the abbreviation μg instead of microgram for the quantity of the active ingredient released per day. The pouch labels for the products do not include the Australian approved name for the active ingredient Estradiol ; do not include the Australian approved name for Estrogen ; do not indicate the location of the batch number and expiry details; do not include the current sponsor address and updated sponsor logo; and includes the abbreviation μg instead of microgram for the quantity of the active ingredient released per day. | The labels to which this consent applies are those provided with the application in the email correspondence dated 9 August 2021. | Supply | Prescription medicines |
| ESTRADERM MX 50 estradiol 50 microgram/24 hours transdermal drug delivery system sachet | Juno Pharmaceuticals Pty Ltd | 56658 | 226240 | CON-859 | The consent is effective from 2 September 2021 until 31 March 2023 or until the batches are depleted. | 2/09/2021 | Section 6, and Paragraphs 8(1)(b), 8(1)(f), 8(1)(g), 8(1)(i), 9(3)(a) and 11(1)(b) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines | The product packaging does not conform with the requirements of Section 6 'name of an active ingredient'; and Paragraphs 8(1)(b), 8(1)(f), 8(1)(g), 8(1)(i), 9(3)(a) and 11(1)(b) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that The carton labels for the products do not include the Australian approved name for the active ingredient Estradiol ; do not include the Australian approved name for Estrogen ; the batch number and expiry date prefixes are not preceding the batch number and expiry date; do not include the current sponsor address and updated sponsor logo; do not include the name and quantity of the active ingredient on one line immediately underneath the medicine name; and includes the abbreviation μg instead of microgram for the quantity of the active ingredient released per day. The pouch labels for the products do not include the Australian approved name for the active ingredient Estradiol ; do not include the Australian approved name for Estrogen ; do not indicate the location of the batch number and expiry details; do not include the current sponsor address and updated sponsor logo; and includes the abbreviation μg instead of microgram for the quantity of the active ingredient released per day. | The labels to which this consent applies are those provided with the application in the email correspondence dated 9 August 2021. | Supply | Prescription medicines |
| ESTRADERM MX 25 estradiol 25 microgram/24 hours (0.75 mg) transdermal drug delivery system sachet | Juno Pharmaceuticals Pty Ltd | 67089 | 226130 | CON-859 | The consent is effective from 2 September 2021 until 31 March 2023 or until the batches are depleted. | 2/09/2021 | Section 6, and Paragraphs 8(1)(b), 8(1)(f), 8(1)(g), 8(1)(i), 9(3)(a) and 11(1)(b) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines | The product packaging does not conform with the requirements of Section 6 'name of an active ingredient'; and Paragraphs 8(1)(b), 8(1)(f), 8(1)(g), 8(1)(i), 9(3)(a) and 11(1)(b) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that The carton labels for the products do not include the Australian approved name for the active ingredient Estradiol ; do not include the Australian approved name for Estrogen ; the batch number and expiry date prefixes are not preceding the batch number and expiry date; do not include the current sponsor address and updated sponsor logo; do not include the name and quantity of the active ingredient on one line immediately underneath the medicine name; and includes the abbreviation μg instead of microgram for the quantity of the active ingredient released per day. The pouch labels for the products do not include the Australian approved name for the active ingredient Estradiol ; do not include the Australian approved name for Estrogen ; do not indicate the location of the batch number and expiry details; do not include the current sponsor address and updated sponsor logo; and includes the abbreviation μg instead of microgram for the quantity of the active ingredient released per day. | The labels to which this consent applies are those provided with the application in the email correspondence dated 9 August 2021. | Supply | Prescription medicines |
| BALANCE LIQUID CARNITINE | Vitaco Health Australia Pty Ltd | 215215 | CON-858 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| BALANCE 100% MICRONISED CREATINE | Vitaco Health Australia Pty Ltd | 192567 | CON-858 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| BALANCE BCAA MUSCLE-GROWTH CAPSULES | Vitaco Health Australia Pty Ltd | 192405 | CON-858 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| BALANCE 100% PURE GLUTAMINE | Vitaco Health Australia Pty Ltd | 192168 | CON-858 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| BALANCE CARNITINE | Vitaco Health Australia Pty Ltd | 130342 | CON-858 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| BALANCE GLUTAMINE 1000 | Vitaco Health Australia Pty Ltd | 129931 | CON-858 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products that do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE ESTER-C + BIOFLAVONOIDS | Vitaco Health Australia Pty Ltd | 284792 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE ESTER-C + CHEWABLES | Vitaco Health Australia Pty Ltd | 283066 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE ESTER-C HIGH STRENGTH + BIOFLAVONOIDS | Vitaco Health Australia Pty Ltd | 219050 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE ESTER-C POWDER | Vitaco Health Australia Pty Ltd | 219048 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE ESTER-C + BIOFLAVONOIDS | Vitaco Health Australia Pty Ltd | 284792 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE JOINT FORMULA + MSM UNFLAVOURED POWDER | Vitaco Health Australia Pty Ltd | 284718 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE JOINT FORMULA + MSM CONCENTRATE POWDER | Vitaco Health Australia Pty Ltd | 284712 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE MAGNESIUM SLEEP | Vitaco Health Australia Pty Ltd | 284655 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE SUPER CALCIUM COMPLETE | Vitaco Health Australia Pty Ltd | 284646 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE JOINT FORMULA + MSM POWDER | Vitaco Health Australia Pty Ltd | 284262 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE ESTER-C + CHEWABLES | Vitaco Health Australia Pty Ltd | 283066 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE OMEGA 3 TRIPLE STRENGTH | Vitaco Health Australia Pty Ltd | 268855 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE DIGESTIVE ENZYMES | Vitaco Health Australia Pty Ltd | 247076 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE CELERY 10,000 | Vitaco Health Australia Pty Ltd | 235360 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE GINKGO 7500 PLUS | Vitaco Health Australia Pty Ltd | 225999 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE LYSINE 1200 | Vitaco Health Australia Pty Ltd | 225074 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE ESTER-C HIGH STRENGTH + BIOFLAVONOIDS | Vitaco Health Australia Pty Ltd | 219050 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE ESTER-C POWDER | Vitaco Health Australia Pty Ltd | 219048 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE GLUCOSAMINE 1500 COMPLEX ADVANCED | Vitaco Health Australia Pty Ltd | 184317 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE FISH OIL 1500 mg PLUS VITAMIN D | Vitaco Health Australia Pty Ltd | 180397 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE FISH OIL 1000 mg | Vitaco Health Australia Pty Ltd | 149891 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE VITAMIN D PLUS | Vitaco Health Australia Pty Ltd | 144652 | CON-853 | The consent is effective from 2 September 2021 until 1 September 2022. | 1/09/2021 | Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text. | Supply | Listed complementary medicines | ||
| NUTRA-LIFE TRIPLE STRENGTH GARLIC + C, HORSERADISH + | Vitaco Health Australia Pty L |