You are here

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 61 - 70 of 215

Consent no.: CON-TGO91-311

Novartis Pharmaceuticals Australia Pty Ltd

Products:

  • AUST R 71445 - EXELON rivastigmine 1.5mg (as hydrogen tartrate) capsule blister pack
  • AUST R 71446 - EXELON rivastigmine 3.0mg (as hydrogen tartrate) capsule blister pack
  • AUST R 71447 - EXELON rivastigmine 4.5mg (as hydrogen tartrate) capsule blister pack
  • AUST R 71448 - EXELON rivastigmine 6mg (as hydrogen tartrate) capsule blister pack
  • AUST R 133422 - EXELON PATCH 5 rivastigmine 4.6mg/24 hours transdermal drug delivery system sachet
  • AUST R 133428 - EXELON PATCH 10 rivastigmine 9.5mg/24 hours transdermal drug delivery system sachet
  • AUST R 222604 - EXELON PATCH 15 rivastigmine 13.3mg/24 hours transdermal drug delivery system sachet

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 17 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-TGO91-307

Sanofi Aventis Australia Pty Ltd

Products:

  • AUST R 150480 - DUOPLIDOGREL 75 mg/100 mg clopidogrel (as hydrogen sulfate)/aspirin tablet blister pack
  • AUST R 150470 - CLOPIDOGREL WINTHROP PLUS ASPIRIN clopidogrel (as hydrogen sulfate)/aspirin 75mg/100 mg Tablet Blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 14 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-TGO91-308

Novartis Pharmaceuticals Australia Pty Ltd

Products:

  • AUST R 49725 - Neoral (ciclosporin) 100 mg/mL oral liquid bottle - Batch ADP425284

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 14 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-TGO91-309

Novartis Pharmaceuticals Australia Pty Ltd

Products:

  • AUST R 160177 ONBREZ BREEZHALER indacaterol maleate 300 microgram hard capsule for inhalation - Batch BRW91

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 14 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-TGO91-310

Dr Reddy's Laboratories (Australia) Pty Ltd

Products:

  • AUST R 200933 - CAPECITABINE-DRLA capecitabine 500 mg tablet blister pack - Batch number H2000188

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 14 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-TGO91-297

Pfizer Australia Pty Ltd

Products:

  • AUST R 14435 - DANTRIUM dantrolene sodium hemiheptahydrate 20 mg powder for injection vial - Batch number 20REV03

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-TGO91-298

Sanofi Aventis Australia Pty Ltd

Products:

  • AUST R 79744 - RILUTEK riluzole 50 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 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-TGO91-299

Sanofi Aventis Australia Pty Ltd

Products:

  • AUST R 27564 - STEMETIL prochlorperazine maleate 5mg tablet blister pack
  • AUST R 67940 - STEMZINE Prochlorperazine maleate 5mg 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 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-TGO91-300

Sanofi Aventis Australia Pty Ltd

Products:

  • AUST R 27555 - STEMETIL prochlorperazine mesilate 12.5 mg/1 mL Injection Ampoule

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-TGO91-301

Lundbeck Australia Pty Ltd

Products:

  • AUSTR 46061 - CLOPIXOL ACUPHASE zuclopenthixol acetate 100mg/2mL injection ampoule

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 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.

Pages