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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 111 - 120 of 215

Consent no.: CON-TGO91-238

Phebra Pty Ltd

Products:

  • AUST R 142075 - GLAUMOX acetazolamide (as sodium) 500 mg powder for injection vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 28 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-TGO91-237

Phebra Pty Ltd

Products:

  • AUST R 153873 - CAFNEA INJECTION caffeine citrate injection 40 mg/2 mL IV injection glass vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 28 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-TGO91-236

Phebra Pty Ltd

Products:

  • AUST R 22934 -ARGININE HYDROCHLORIDE 60% INJECTION (15 g/25 mL) vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 28 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-TGO91-273

Bristol Myers Squibb Australia Pty Ltd

Products:

  • AUST R 99056 - REYATAZ atazanavir 200mg capsule bottle - Batch number LK0116

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 28 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.
Consent no.: CON-TGO91-257

Novartis Pharmaceuticals Australia Pty Ltd

Products:

  • AUST R 93165 - DIOVAN valsartan 40mg film-coated tablet blister pack
  • AUST R 80868 - DIOVAN valsartan 80mg film-coated tablet blister pack
  • AUST R 80871 - DIOVAN valsartan 160mg film-coated tablet blister pack
  • AUST R 123357 - DIOVAN valsartan 320 mg 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 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-TGO91-256

Novartis Pharmaceuticals Australia Pty Ltd

Products:

  • AUST R 157954 - EXFORGE HCT 5/160/12.5 amlodipine/valsartan/hydrochlorothiazide tablet blister pack
  • AUST R 158164 - EXFORGE HCT 10/160/12.5 amlodipine/valsartan/hydrochlorothiazide tablet blister pack
  • AUST R 158162 - EXFORGE HCT 5/160/25 amlodipine/valsartan/hydrochlorothiazide tablet blister pack
  • AUST R 158166 - EXFORGE HCT 10/160/25 amlodipine/valsartan/hydrochlorothiazide tablet blister pack
  • AUST R 158168 - EXFORGE HCT 10/320/25 amlodipine/valsartan/hydrochlorothiazide 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 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-TGO91-255

Baxter Healthcare Pty Ltd

Products:

  • AUST R 19468 - BAXTER 0.22% POTASSIUM CHLORIDE and HARTMANN'S SOLUTION 1000 mL injection bag AHB2954

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 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-TGO91-254

Novartis Pharmaceuticals Australia Pty Ltd

Products:

  • AUST R 160228 - RITALIN LA methylphenidate hydrochloride 10 mg modified release capsule bottle
  • batches: APCC645; APCC708
  • AUST R 82957 - RITALIN LA methylphenidate hydrochloride 20mg modified release capsule bottle
  • batches: APCC865, APCC705
  • AUST R 82958 - RITALIN LA methylphenidate hydrochloride 30mg modified release capsule bottle
  • batch: APCC660
  • AUST R 82959 - RITALIN LA methylphenidate hydrochloride 40mg modified release capsule bottle
  • batches: APCC683; APCC707
  • AUST R 236251 - RITALIN LA methylphenidate hydrochloride 60mg modified release capsules bottle
  • batches: APCC819, APCC840

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 27 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.
Consent no.: CON-TGO91-253

Novartis Pharmaceuticals Australia Pty Ltd

Products:

  • AUST R 161824 - EXFORGE 10/320 amlodipine (as besilate) and valsartan 10/320mg film-coated tablet blister pack
  • AUST R 161820 - EXFORGE 5/320 amlodipine (as besilate) and valsartan 5/320mg film-coated tablet blister pack
  • AUST R 130787 - EXFORGE 5/80 amlodipine 5mg (as besilate)/valsartan 80mg film-coated tablet blister pack
  • AUST R 130834 - EXFORGE 5/160 amlodipine 5mg (as besilate)/valsartan 160mg film-coated tablets blister pack
  • AUST R 130841 - EXFORGE 10/160 amlodipine 10mg (as besilate)/valsartan 160mg 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 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-TGO91-258

Commercial Eyes Pty Ltd

Products:

  • AUST R 93909 - INTAL CFC-FREE INHALER sodium cromoglycate 1mg/actuation can
  • AUST R 67820 - INTAL FORTE CFC-FREE INHALER sodium cromoglycate 5mg/actuation inhalation metered dose aerosol can

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 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.

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