CON-TGO91-172 - Commercial Eyes Pty Ltd on behalf of Sanofi-Aventis Australia Pty Ltd
Product names
- AUST R 150021 - SABRIL vigabatrin 500 mg tablet blister pack
- AUST R 52985 - SABRIL vigabatrin 0.5 g powder oral sachet
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