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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 71 - 80 of 215

Consent no.: CON-TGO91-302

Mylan Health Pty Ltd

Products:

  • AUST R 14945 - ENDONE oxycodone hydrochloride 5 mg tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 11 September 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 31 October 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-TGO91-303

Sanofi Aventis Australia Pty Ltd

Products:

  • AUST R 139787 - THYMOGLOBULINE rabbit antithymocyte immunoglobulin Powder for solution for infusion vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 11 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-TGO91-304

Pfizer Australia Pty Ltd

Products:

  • AUST R 10804 - Pfizer (Perth) SODIUM CHLORIDE 0.9% (450 mg/50 mL) injection BP vial - Batch Numbers EA2889, EA5939, EC7759, EF2334, EF2335
  • AUST R 11290 - Pfizer (Perth) SODIUM CHLORIDE 0.9% irrigation solution ampoule - Batch Numbers DL6784
  • AUST R 49272 - Pfizer (Perth) SODIUM CHLORIDE 0.9% (45 mg/5 mL) injection BP ampoule - Batch Numbers B566, B518
  • AUST R 49278 - Pfizer (Perth) SODIUM CHLORIDE 0.9% (90 mg/10 mL) injection BP ampoule - Batch Numbers DX1934, DX1935, DY8946, DY8947, EC4045, EC4046
  • AUST R 49280 - Pfizer (Perth) SODIUM CHLORIDE 0.9% (900 mg/100 mL) injection BP vial - Batch Numbers DD0061/ DD0062

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 11 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-TGO91-305

Mylan Health Pty Ltd

Products:

  • AUST R 11971 - QUESTRAN LITE colestyramine 850mg/g powder sachet

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 11 September 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-TGO91-306

Sanofi Aventis Australia Pty Ltd

Products:

  • AUST R 158423 - MOZOBIL plerixafor 20 mg/mL solution for injection 1.2 mL vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 11 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-TGO91-288

Arrow Pharma Pty Ltd

Products:

  • AUST R 79023 - NIDEM gliclazide 80 mg tablet blister pack - batch numbers: 7243514 and 7243515

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 9 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-TGO91-289

Pfizer Australia Pty Ltd

Products:

  • AUST R 161275 - DBL ROCURONIUM BROMIDE INJECTION rocuronium bromide 50mg/5mL injection solution vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 9 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-TGO91-291

Mylan Health Pty Ltd

Products:

  • AUST R 14937 - COUMADIN warfarin sodium 2mg tablet bottle - Batch DF487

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 9 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-TGO91-292

Pfizer Australia Pty Ltd

Products:

  • AUST R 62603 - DBL VANCOMYCIN vancomycin (as hydrochloride) 500mg powder for injection vial - Batch numbers: H056913AA, H056913BA and H046913AA

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 9 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-TGO91-293

Novartis Pharmaceuticals Australia Pty Ltd

Products:

  • AUST R 76201 - TRILEPTAL oxcarbazepine 300 mg tablet film coated blister pack
  • AUST R 76200 - TRILEPTAL oxcarbazepine 150 mg tablet film coated blister pack
  • AUST R 76202 - TRILEPTAL oxcarbazepine 600 mg tablet film coated blister pack
  • AUST R 81195 - TRILEPTAL oxcarbazepine 60 mg/mL oral suspension bottle

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 9 September 2020

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