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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 11 - 20 of 215

Consent no.: CON-TGO91-362

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 134367 - SODIUM VALPROATE SANDOZ sodium valproate 200mg enteric coated tablet blister pack
  • AUST R 134368 - SODIUM VALPROATE SANDOZ sodium valproate 500mg enteric coated tablet blister pack
  • AUST R 286315 - VALPRO EC200 sodium valproate 200 mg enteric coated tablet blister pack
  • AUST R 286316 - VALPRO EC500 sodium valproate 500 mg enteric coated tablet blister pack
  • AUST R 125620 - VALPROATE WINTHROP EC200 sodium valproate 200mg tablet blister pack
  • AUST R 125621 - VALPROATE WINTHROP EC500 sodium valproate 500mg tablet blister pack
  • AUST R 15369 - EPILIM EC200 sodium valproate 200mg tablet blister pack (OF)
  • AUST R 15373 - EPILIM sodium valproate 100mg crushable tablet blister pack
  • AUST R 15370 - EPILIM EC500 sodium valproate 500mg tablet blister pack (OF)

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 12 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-TGO91-363

Juno Pharmaceuticals Pty Ltd

Products:

  • AUST R 219054 - Neostigmine Juno neostigmine methylsulfate 2.5 mg/1 ml solution for injection ampoule - Batch number 021011

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 12 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-TGO91-364

LINK Medical Products Pty Ltd

Products:

  • AUST R 210672 - ADRENALINE-LINK 1:10,000 1mg/10mL adrenaline (epinephrine) acid tartrate injection BP pre filled syringe - Batch number 0130731

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 12 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-TGO91-365

Merck Sharp and Dohme Australia Pty Limited

Products:

  • AUST R 55088 - LIVIAL tibolone 2.5 mg tablet blister pack, 28 tablets.

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 12 October 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 1 January 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-TGO91-352

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 192672 - AUBAGIO teriflunomide 14 mg film-coated tablets 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 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-TGO91-351

Novartis Pharmaceuticals Australia Pty Ltd

Products:

  • AUST R 161826 - AMLODIPINE/VALSARTAN NOVARTIS 10/320 amlodipine 10 mg/valsartan 320 mg film-coated tablet blister pack
  • AUST R 161825 - AMLODIPINE/VALSARTAN NOVARTIS 5/320 amlodipine 5 mg/valsartan 320 mg film-coated tablet blister pack
  • AUST R 151628 - AMLODIPINE/VALSARTAN NOVARTIS 10/160 amlodipine 10 mg /valsartan 160 mg film-coated tablet blister pack
  • AUST R 151627 - AMLODIPINE/VALSARTAN NOVARTIS 5/160 amlodipine 5 mg/valsartan 160 mg film-coated tablets blister pack
  • AUST R 151626 - AMLODIPINE/VALSARTAN NOVARTIS 5 / 80 amlodipine 5 mg/valsartan 80 mg film-coated 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-TGO91-350

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 81900 - XATRAL SR alfuzosin 10mg (as hydrochloride) 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 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-TGO91-349

Mylan Health Pty Ltd

Products:

  • AUST R 164131 - VIATOCINON oxytocin 10 IU/1 mL injection ampoule - Batch AS001X1

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-TGO91-353

Juno Pharmaceuticals Pty Ltd

Products:

  • AUST R 275811 - TIGECYCLINE JUNO tigecycline 50 mg Powder for injection Glass 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-TGO91-354

Juno Pharmaceuticals Pty Ltd

Products:

  • AUST R 209215 - TIROSTAT tirofiban (as hydrochloride) 12.5mg/50mL Concentrated Injection for infusion Vial
  • AUST R 209216 - TIROFIBAN JUNO tirofiban (as hydrochloride) 12.5mg/50mL Concentrated Injection for infusion 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.

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