CON-TGO91-333 - Sanofi-Aventis Australia Pty Ltd
Product names
- AUST R 96422 - SOLIAN 100 amisulpride 100 mg tablet blister pack
- AUST R 96425 - SOLIAN 200 amisulpride 200 mg tablet blister pack
- AUST R 74272 - SOLIAN 400 amisulpride 400 mg tablet blister pack
- AUST R 125173 - AMISULPRIDE 100 WINTHROP amisulpride 100 mg tablet blister pack
- AUST R 125174 - AMISULPRIDE 200 WINTHROP amisulpride 200 mg tablet blister pack
- AUST R 125165 - AMISULPRIDE 400 WINTHROP amisulpride 400 mg tablet blister pack
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