CON-TGO91-355 - Guerbet Australia Pty Ltd
Product names
- AUST R 160798 - DOTAREM gadoteric acid 279.32 mg/mL injection 10 mL prefilled syringe - Batch number 19GS799B
Sponsor
Decision Date
Duration
The duration of consent is for the batches specified above.
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