CON-TGO91-200 - Guerbet Australia Pty Ltd
Product names
- ARTG 160798 - DOTAREM gadoteric acid 279.32mg/mL injection 10 mL pre-filled syringe - Batch numbers 19GS701B, 19GS718A, 19GS777B, 19GS799A and 19GS800A
- ARTG 160799 - DOTAREM gadoteric acid 279.32mg/mL injection 15 mL pre-filled syringe - Batch numbers 19GS764B, 19GS784B, 19GS806A, and 19GS807B
- ARTG 160800 - DOTAREM gadoteric acid 279.32mg/mL injection 20 mL pre-filled syringe - Batch numbers 18GS504A and 19GS791A
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