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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 81 - 90 of 215

Consent no.: CON-TGO91-294

Baxter Healthcare Pty Ltd

Products:

  • AUST R 19479 - 10% OSMITROL Mannitol 100 g/L injection bag AHB3026 1000 mL
  • AUST R 19496 - 20% OSMITROL Mannitol 100 g/500 mL injection bag AHB3025

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-TGO91-295

Pfizer Australia Pty Ltd

Products:

  • AUST R 70073 - Ketalar ketamine (as hydrochloride) 200 mg/2 mL - Batch number H037900AA

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-TGO91-296

Novartis Pharmaceuticals Australia Pty Ltd

Products:

  • AUST R 161216 - GALVUMET 50/500 vildagliptin 50 mg/metformin hydrochloride 500 mg film coated tablet blister pack
  • AUST R 61217 - GALVUMET 50/850 vildagliptin 50 mg/metformin hydrochloride 850 mg film coated tablet blister pack
  • AUST R 161218 - GALVUMET 50/1000 vildagliptin 50 mg/metformin hydrochloride 1000 mg film coated tablet blister pack

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-TGO91-290

Merck Sharp and Dohme Australia Pty Limited

Products:

  • AUST R 181338 - STROMECTOL ivermectin 3mg tablet blister pack

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 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-TGO91-276

Lundbeck Australia Pty Ltd

Products:

  • AUST R 45082 - CLOPIXOL DEPOT zuclopenthixol decanoate 200 mg/1 mL injection 5x1 ampoule

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 4 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-TGO91-284

Bayer Australia Ltd

Products:

  • AUST R 156920 - ANDROCUR cyproterone acetate 50 mg tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 4 September 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 31 May 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-TGO91-285

Novartis Pharmaceuticals Australia Pty Ltd

Products:

  • ARTG 169890 - GILENYA fingolimod (as hydrochloride) 0.5 mg capsule blister pack - pack of 7 capsules

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 4 September 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 30 April 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-TGO91-286

Lundbeck Australia Pty Ltd

Products:

  • AUST R 156299 - EBIXA memantine hydrochloride 20 mg film-coated tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 4 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-TGO91-287

AstraZeneca Pty Ltd

Products:

  • AUST R 10072 - Pulmicort Respules (budesonide) 250µg/mL inhalation ampoule
  • AUST R 10071 - Pulmicort Respules (budesonide) 500µg/mL inhalation ampoule

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 4 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-TGO91-274

Apotex Pty Ltd

Products:

  • AUST R 224300 - APO-Perindopril Arginine/Amlodipine 10/10 perindopril arginine 10 mg and amlodipine (as besilate) 10 mg uncoated tablet bottle - Batch Numbers RT8405 and RT8406

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 3 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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