CON-TGO91-148 - Seqirus Pty Ltd
Product names
- AUST R 165357 - PALEXIA SR tapentadol (as hydrochloride) 250 mg sustained release tablet
- AUST R 165356 - PALEXIA SR tapentadol (as hydrochloride) 200mg sustained release tablet
- AUST R 165347 - PALEXIA SR tapentadol (as hydrochloride) 150 mg sustained release tablet
- AUST R 165346 - PALEXIA SR tapentadol (as hydrochloride) 100 mg sustained release tablet
- AUST R 165332 - PALEXIA SR tapentadol (as hydrochloride) 50 mg sustained release tablet
- AUST R 165310 - PALEXIA IR tapentadol (as hydrochloride) 50 mg tablet
Sponsor
Decision Date
Duration
The consent is effective for all batches manufactured from 1 September 2020 until 31 December 2020.
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