CON-TGO91-335 - Sanofi-Aventis Australia Pty Ltd
Product names
- AUST R 15372 - EPILIM SYRUP sodium valproate 40 mg/mL oral liquid bottle
- AUST R 74711 - EPILIM LIQUID sodium valproate 40 mg/mL sugar free oral liquid bottle
- AUST R 104416 - EPILIM IV sodium valproate 400 mg powder for injection vial with diluent ampoule
Sponsor
Decision Date
Duration
The consent is effective for all batches manufactured between 1 September 2020 and 31 March 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