CON-TGO91-332 - Sanofi-Aventis Australia Pty Ltd
Product names
- AUST R 99145 - APIDRA insulin glulisine (rbe) 100IU/mL 10 mL injection vial
- AUST R 99146 - APIDRA insulin glulisine (rbe) 100IU/mL 3mL injection cartridge
Sponsor
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