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CON-TGO91-196 - Merck Sharp and Dohme Australia Pty Limited
Product names
- AUST R 149021 - JANUMET 50 mg/850 mg sitagliptin phosphate monohydrate/metformin HCI 50 mg/850 mg tablet blister pack
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