CON-TGO91-362 - Sanofi-Aventis Australia Pty Ltd
Product names
- AUST R 134367 - SODIUM VALPROATE SANDOZ sodium valproate 200mg enteric coated tablet blister pack
- AUST R 134368 - SODIUM VALPROATE SANDOZ sodium valproate 500mg enteric coated tablet blister pack
- AUST R 286315 - VALPRO EC200 sodium valproate 200 mg enteric coated tablet blister pack
- AUST R 286316 - VALPRO EC500 sodium valproate 500 mg enteric coated tablet blister pack
- AUST R 125620 - VALPROATE WINTHROP EC200 sodium valproate 200mg tablet blister pack
- AUST R 125621 - VALPROATE WINTHROP EC500 sodium valproate 500mg tablet blister pack
- AUST R 15369 - EPILIM EC200 sodium valproate 200mg tablet blister pack (OF)
- AUST R 15373 - EPILIM sodium valproate 100mg crushable tablet blister pack
- AUST R 15370 - EPILIM EC500 sodium valproate 500mg tablet blister pack (OF)
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