QUADRACEL 0.5 mL injection vial, Sanofi Aventis Australia Pty Ltd, CON-205
Product name
QUADRACEL 0.5 mL injection vial
Sponsor name
Sanofi Aventis Australia Pty Ltd
ARTG
91355
Batches
C5324 - 150,000 doses only
Consent start
Consent no.
CON-205
Standard
European Pharmacopoeia
Non-compliance with standard
The productis tested to the United States, rather than Australian
specifications, as detailed in the application letter.
Conditions imposed
1. This consent applies only to 150,000 doses from Quadracel
C5324.2.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