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CON-TGO91-351 - Novartis Pharmaceuticals Australia Pty Ltd

Product names
  • AUST R 161826 - AMLODIPINE/VALSARTAN NOVARTIS 10/320 amlodipine 10 mg/valsartan 320 mg film-coated tablet blister pack
  • AUST R 161825 - AMLODIPINE/VALSARTAN NOVARTIS 5/320 amlodipine 5 mg/valsartan 320 mg film-coated tablet blister pack
  • AUST R 151628 - AMLODIPINE/VALSARTAN NOVARTIS 10/160 amlodipine 10 mg /valsartan 160 mg film-coated tablet blister pack
  • AUST R 151627 - AMLODIPINE/VALSARTAN NOVARTIS 5/160 amlodipine 5 mg/valsartan 160 mg film-coated tablets blister pack
  • AUST R 151626 - AMLODIPINE/VALSARTAN NOVARTIS 5 / 80 amlodipine 5 mg/valsartan 80 mg film-coated tablet blister pack
Decision Date
Duration
The consent is effective for all batches manufactured between 1 September 2020 and 31 August 2021.
Non-compliance with standard

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.

Supply/Import or Export
Supply
Therapeutic good type
Prescription medicines

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