CON-TGO91-225 - Commercial Eyes Pty Ltd
Product names
- AUST R 238285 - PRALUENT alirocumab (rch) 75mg/mL solution for injection, pre-filled pen
- AUST R 238299 - PRALUENT alirocumab (rch) 150mg/mL solution for injection pre-filled pen
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