CON-TGO91-209 - CSL Behring
Product names
- AUST R 173315 - EVOGAM normal immunoglobulin (human) 16% w/v, 0.8g/5mL injection solution vial for subcutaneous use
- AUST R 173324 - EVOGAM normal immunoglobulin (human) 16% w/v, 3.2g/20mL injection solution vial for subcutaneous use
Sponsor
Decision Date
Duration
The consent is effective for all batches manufactured between 1 September 2020 and 30 April 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