CON-TGO91-176 - Sun Pharma ANZ Pty Ltd
Product names
- AUST R 116623 - SETRONA sertraline (as hydrochloride) 50 mg tablet blister pack
- AUST R 116636 - SETRONA sertraline (as hydrochloride) 100 mg tablet blister pack
Sponsor
Decision Date
Duration
The consent is effective for all batches manufactured between 1 September 2020 and 28 February 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