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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 121 - 130 of 215

Consent no.: CON-TGO91-259

Accord Healthcare

Products:

  • AUST R 184833 - MONTELUKAST SANDOZ 5 montelukast 5 mg (as sodium) chewable tablet blister pack
  • AUST R 184832 - MONTELUKAST SANDOZ 4 montelukast 4 mg (as sodium) chewable tablet blister pack
  • AUST R 184830 - MONTELUKAST SANDOZ 10 montelukast 10 mg (as sodium) film-coated tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 27 August 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 29 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-TGO91-262

Sandoz Pty Ltd

Products:

  • AUST R 120618 - METHOTREXATE EBEWE methotrexate 5000 mg/50 mL concentrated injection vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 27 August 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 29 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-TGO91-263

Sandoz Pty Ltd

Products:

  • AUST R 140840- PIPERTAZ SANDOZ 4 g/ 0.5 g piperacillin (as sodium) 4 g and tazobactam (as sodium) 0.5 g powder for injection bottle

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 27 August 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 29 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-TGO91-264

Sandoz Pty Ltd

Products:

  • AUST R 210043 - PREGABALIN SANDOZ pregabalin 75 mg capsule blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 27 August 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 29 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-TGO91-266

Sandoz Pty Ltd

Products:

  • AUST R 99724-VINORELBINE EBEWE 50 mg/5 mL (as tartrate) injection vial
  • AUST R 126693-VINORELBINE EBEWE 10 mg/1 mL (as tartrate) injection vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 27 August 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 29 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-TGO91-270

Sandoz Pty Ltd

Products:

  • AUST R 193204 - LEVETIRACETAM SANDOZ levetiracetam 500 mg /5 mL concentrate solution for IV infusion vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 27 August 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 29 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-TGO91-271

Sandoz Pty Ltd

Products:

  • AUST R 292865 - SANDOZ METFORMIN metformin hydrochloride 1000 mg tablet blister pack
  • AUST R 125661- METFORMIN SANDOZ metformin hydrochloride 500 mg tablet blister pack
  • AUST R 125662 - METFORMIN SANDOZ metformin hydrochloride 850 mg tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 27 August 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 29 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-TGO91-226

Bayer Australia Ltd

Products:

  • AUST R 207595 - ADEMPAS riociguat 0.5 mg film-coated tablet blister pack
  • AUST R 207599 - ADEMPAS riociguat 1 mg film-coated tablet blister pack
  • AUST R 207597 - ADEMPAS riociguat 1.5 mg film-coated tablet blister pack
  • AUST R 207598 - ADEMPAS riociguat 2 mg film-coated tablet blister pack
  • AUST R 207596 - ADEMPAS riociguat 2.5 mg film-coated tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 26 August 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 31 October 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-TGO91-234

Baxter Healthcare Pty Ltd

Products:

  • AUST R 48490 - BAXTER COMPOUND SODIUM LACTATE SOLUTION and 5% GLUCOSE 1000 mL injection bag - AHB2074

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 24 August 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-TGO91-235

Servier Laboratories Aust Pty Ltd

Products:

  • AUST R 34266 - IDAPREX 2 perindopril erbumine 2mg tablet blister pack
  • Batch Numbers: 6012610 and 6012632
  • AUST R 34267 - IDAPREX 4 perindopril erbumine 4mg tablet blister pack
  • Batch Numbers: 677296; 677887; 6002152; 678879 and 6002173
  • AUST R 96738 - IDAPREX 8 perindopril erbumine 8mg tablet blister pack
  • Batch Numbers: 678646; 678375 and 678645

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 24 August 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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