CON-TGO91-294 - Baxter Healthcare Pty Ltd
Product names
- AUST R 19479 - 10% OSMITROL Mannitol 100 g/L injection bag AHB3026 1000 mL
- AUST R 19496 - 20% OSMITROL Mannitol 100 g/500 mL injection bag AHB3025
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