CON-TGO91-293 - Novartis Pharmaceuticals Australia Pty Ltd
Product names
- AUST R 76201 - TRILEPTAL oxcarbazepine 300 mg tablet film coated blister pack
- AUST R 76200 - TRILEPTAL oxcarbazepine 150 mg tablet film coated blister pack
- AUST R 76202 - TRILEPTAL oxcarbazepine 600 mg tablet film coated blister pack
- AUST R 81195 - TRILEPTAL oxcarbazepine 60 mg/mL oral suspension bottle
Decision Date
Duration
The consent is effective for all batches manufactured between 1 September 2020 and 30 June 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