QUADRACEL 0.5 mL injection vial, Sanofi Aventis Australia Pty Ltd, CON-150
Product name
QUADRACEL 0.5 mL injection vial
Sponsor name
Sanofi Aventis Australia Pty Ltd
ARTG
91355
Batches
C5020AA - expiry 28 February 2018 C5222AC - expiry 30 November 2018
Consent start
Consent no.
CON-150
Standard
The product does not conform to the requirements of the European Pharmacopoeia.
Non-compliance with standard
It is tested to the United States rather than Australian specifications.
Conditions imposed
1. This consent applies only to 30000 doses from Quadracel batch C5020AA and
60000 doses from batch C5222AC 2. Non'compliance with the European Pharmacopoeia
requirements is limited to the tests detailed in the application 3. The doses
will be labelled in the Australian approved labels (carton, vial and package
insert) 4. The company will provide TGA with a copy of the Release Certificate
of the relevant bulk from US CBER 5. Normal TGA batch release processes will
apply to this batch
Therapeutic product type
Prescription medicines