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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 31 - 40 of 215

Consent no.: CON-TGO91-341

Mylan Health Pty Ltd

Products:

  • AUST R 172973 - TEMIZOLE 5 temozolomide 5 mg capsule bottle - batch number P2005410
  • AUST R172968 - TEMIZOLE 20 temozolomide 20 mg capsule bottle - batch number P2005010
  • AUST R 172964 - TEMIZOLE 100 temozolomide 100 mg capsule bottle - batch number P2004996
  • AUST R 172972 - TEMIZOLE 140 temozolomide 140 mg capsule bottle - batch number P2004995
  • AUST R 172975 - TEMIZOLE 250 temozolomide 250 mg capsule bottle - batch number P2005387

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 6 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-TGO91-343

Mylan Health Pty Ltd

Products:

  • AUST R 226337 - CODALGIN FORTE 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 30 November 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-TGO91-344

Pfizer Australia Pty Ltd

Products:

  • AUST R 75107 - PAMISOL pamidronate disodium 30mg/10mL injection vial - Batch number H034935AC

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 6 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-TGO91-345

Pfizer Australia Pty Ltd

Products:

  • AUST R 75832 - DBL FLUOROURACIL INJECTION BP fluorouracil 2.5g/50mL injection vial - Batch Number H022589AA

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 6 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-TGO91-337

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 92753 - ARABLOC leflunomide 10 mg tablet bottle
  • AUST R 92754 - ARABLOC leflunomide 20 mg tablet bottle
  • AUST R 69692 - ARAVA Leflunomide 10 mg tablet bottle
  • AUST R 69694 - ARAVA Leflunomide 20 mg tablet bottle

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 30 September 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-TGO91-336

GSK

Products:

  • AUSTR 97842 - PRIORIX ALBUMIN FREE VACCINE 0.5mL powder for injection vial and diluent syringe

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 30 September 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 28 February 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-TGO91-334

Dr Reddy's Laboratories Australia Pty Ltd

Products:

  • AUST R 200933 - CAPECITABINE-DRLA capecitabine 500 mg tablet blister pack
  • AUST R 200935 - CAPECITABINE-DRLA capecitabine 150 mg tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 28 September 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 30 November 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-TGO91-335

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 15372 - EPILIM SYRUP sodium valproate 40 mg/mL oral liquid bottle
  • AUST R 74711 - EPILIM LIQUID sodium valproate 40 mg/mL sugar free oral liquid bottle
  • AUST R 104416 - EPILIM IV sodium valproate 400 mg powder for injection vial with diluent ampoule

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 28 September 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-TGO91-333

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 96422 - SOLIAN 100 amisulpride 100 mg tablet blister pack
  • AUST R 96425 - SOLIAN 200 amisulpride 200 mg tablet blister pack
  • AUST R 74272 - SOLIAN 400 amisulpride 400 mg tablet blister pack
  • AUST R 125173 - AMISULPRIDE 100 WINTHROP amisulpride 100 mg tablet blister pack
  • AUST R 125174 - AMISULPRIDE 200 WINTHROP amisulpride 200 mg tablet blister pack
  • AUST R 125165 - AMISULPRIDE 400 WINTHROP amisulpride 400 mg tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 25 September 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-TGO91-332

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 99145 - APIDRA insulin glulisine (rbe) 100IU/mL 10 mL injection vial
  • AUST R 99146 - APIDRA insulin glulisine (rbe) 100IU/mL 3mL injection cartridge

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 25 September 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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