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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 51 - 60 of 215

Consent no.: CON-TGO91-324

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 67183 - TRIASYN 5.0/5.0 tablet blister pack
  • AUST R 67184 - TRIASYN 2.5/2.5 tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 23 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-TGO91-325

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 42422 - ORUVAIL SR ketoprofen 200mg capsule blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 23 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-TGO91-326

BrandwoodCKC

Products:

  • AUST R 215523 - VIMIZIM elosulfase alfa (rch) 1 mg/mL concentrated solution for injection vial - Batch number L401816

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 23 September 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-TGO91-327

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 101831 - KARVEZIDE 150/12.5 irbesartan 150 mg and hydrochlorothiazide 12.5 mg tablet blister pack
  • AUST R 101833 - KARVEZIDE 300/12.5 irbesartan 300 mg and hydrochlorothiazide 12.5 mg tablet blister pack
  • AUST R 102017 - AVAPRO HCT 150/12.5 irbesartan 150 mg and hydrochlorothiazide 12.5 mg tablet blister pack
  • AUST R 102086 - AVAPRO HCT 300/12.5 irbesartan 300 mg and hydrochlorothiazide 12.5 mg tablet blister pack
  • AUST R 129436 - AVAPRO HCT 300/25 irbesartan 300mg and hydrochlorothiazide 25mg tablet blister pack
  • AUST R 129442 - KARVEZIDE 300/25 irbesartan 300mg and hydrochlorothiazide 25mg tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 23 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-TGO91-320

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 150443 - COPLAVIX 75 mg/100 mg clopidogrel (as hydrogen sulfate)/aspirin tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 23 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-TGO91-315

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 160173 - METRONIDE 200 metronidazole 200 mg tablet blister pack
  • AUST R 160175 - METRONIDE 400 metronidazole 400 mg tablet blister pack
  • AUST R 160171 - FLAGYL metronidazole 200 mg tablet blister pack
  • AUST R 160174 - FLAGYL metronidazole 400 mg tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 21 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-TGO91-313

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 76767 - LASIX furosemide (frusemide) 40mg/4mL injection ampoule
  • AUST R 12404 - LASIX furosemide (frusemide) 20mg/2mL injection ampoule

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 21 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-TGO91-314

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 120707 - STILNOX CR Zolpidem tartrate 6.25mg modified release tablet blister pack
  • AUST R 120713 - STILNOX CR Zolpidem tartrate 12.5mg modified release tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 21 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-TGO91-317

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 12406 - LASIX furosemide (frusemide) 40mg tablet bottle
  • AUST R 12408 - LASIX HIGH DOSE furosemide (frusemide) 250mg/25mL injection ampoule
  • AUST R 12409 - LASIX M furosemide (frusemide) 20mg tablet bottle
  • AUST R 232815 - LASIX furosemide (frusemide) 10mg/mL oral liquid bottle

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 21 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-TGO91-312

LINK Medical Products Pty Ltd

Products:

  • AUST R -12048 - ADRENALINE-LINK 1:1,000 1 mg/1 mL adrenaline (epinephrine) acid tartrate injection BP ampoule - batch numbers: 0129366, 0128994, 0129812

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 17 September 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.

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