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Database of consents to import, supply or export therapeutic goods that do not comply with TGO 91 due to COVID-19

12 November 2020

Medicines and other therapeutic goods must conform 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 conform with an applicable standard. The Secretary can impose conditions on the consent under section 15 of the Act.

As a direct result of COVID-19, some prescription medicine manufacturers experienced difficulty in introducing labels that were assessed to be compliant with TGO91 into their manufacturing process by the end of the transition period from TGO 69 (1 September 2020). In recognition of this problem, we introduced a special section 14 application process specifically for these instances. The expedited process ceased on 9 October 2020. Any further section 14 requests should apply via the standard section 14 process.

The records below include information about these decisions, and any subsequent review of such decisions.

To view records of all other consent decisions, refer to Database of consents to import, supply or export therapeutic goods that do not comply with standards

Displaying 21 - 30 of 215

Consent no.: CON-TGO91-355

Guerbet Australia Pty Ltd

Products:

  • AUST R 160798 - DOTAREM gadoteric acid 279.32 mg/mL injection 10 mL prefilled syringe - Batch number 19GS799B

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 9 October 2020

Duration: The duration of consent is for the batches specified above.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-356

Novartis Pharmaceuticals Australia Pty Ltd

Products:

  • AUST R 158169 - AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/320/25 amlodipine/valsartan/hydrochlorothiazide tablet blister pack
  • AUST R 158161 - AMLODIPINE/VALSARTAN/HCT NOVARTIS 5/160/12.5 amlodipine/valsartan/hydrochlorothiazide tablet blister pack
  • AUST R 158163 -AMLODIPINE/VALSARTAN/HCT NOVARTIS 5/160/25 amlodipine/valsartan/hydrochlorothiazide tablet blister pack
  • AUST R 158165 - AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/160/12.5 amlodipine/valsartan/hydrochlorothiazide tablet blister pack
  • AUST R 158167 - AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/160/25 amlodipine/valsartan/hydrochlorothiazide tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 9 October 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 31 August 2021.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-357

AbbVie Pty Ltd

Products:

  • AUST R 133452 - DUODOPA levodopa / carbidopa monohydrate 20 mg/mL and 5 mg/mL intestinal gel PVC bag - Batch Number 20G05G14A

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 9 October 2020

Duration: The duration of consent is for the batches specified above.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-358

Juno Pharmaceuticals Pty Ltd

Products:

  • AUST R 92840 - IBIMICYN ampicillin 1g (as sodium) powder for injection vial
  • AUST R 92839 - IBIMICYN ampicillin 500 mg (as sodium) powder for injection vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 9 October 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 1 March 2021.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-359

Juno Pharmaceuticals Pty Ltd

Products:

  • AUST R 269158 - AMOXICLAV JUNO 2000/200 amoxicillin (as sodium) 2000 mg and clavulanic acid (as potassium clavulanate) 200mg powder for injection vial
  • AUST R 269159 - AMOXICLAV JUNO 1000/200 amoxicillin (as sodium) 1000 mg and clavulanic acid (as potassium clavulanate) 200mg powder for injection vial
  • AUST R 269162 - AMOXICLAV JUNO 1000/200 amoxicillin (as sodium) 1000 mg and clavulanic acid (as potassium clavulanate) 200mg powder for injection vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 9 October 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 1 March 2021.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-346

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 101553 - RENAGEL sevelamer hydrochloride 800 mg tablet bottle

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 8 October 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 31 March 2021.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-338

Bayer Australia Ltd

Products:

  • AUST R 73962 - CLIMARA 25 estradiol 25 microgram/day transdermal drug delivery system sachet
  • AUST R 73963 - CLIMARA 75 estradiol 75 microgram/day transdermal drug delivery system sachet

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 6 October 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 30 April 2021.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-339

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 10113 - RIFADIN rifampicin 20 mg/mL oral liquid bottle
  • AUST R 156919 - RIFADIN rifampicin 600 mg powder for injection vial with diluent ampoule
  • AUST R 233442 - RIFADIN rifampicin 150 mg capsules blister pack
  • AUST R 233443 - RIFADIN rifampicin 300 mg capsules blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 6 October 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 31 May 2021.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-342

Dr Reddy's Laboratories Australia Pty Ltd

Products:

  • AUST R 186299 - SILDENAFIL GENERICHEALTH Sildenafil (as citrate) 100 mg film-coated tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 6 October 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 31 December 2020.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-340

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 175500 - JEVTANA cabazitaxel 60mg/1.5mL concentrated injection vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 6 October 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 31 March 2021.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.

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