CON-TGO91-296 - Novartis Pharmaceuticals Australia Pty Ltd
Product names
- AUST R 161216 - GALVUMET 50/500 vildagliptin 50 mg/metformin hydrochloride 500 mg film coated tablet blister pack
- AUST R 61217 - GALVUMET 50/850 vildagliptin 50 mg/metformin hydrochloride 850 mg film coated tablet blister pack
- AUST R 161218 - GALVUMET 50/1000 vildagliptin 50 mg/metformin hydrochloride 1000 mg film coated tablet blister pack
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