CON-TGO91-253 - Novartis Pharmaceuticals Australia Pty Ltd
Product names
- 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
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