QUADRACEL 0.5 mL injection vial, Sanofi Pasteur Australia Pty Ltd, CON-75
Product name
QUADRACEL 0.5 mL injection vial
Sponsor name
Sanofi Pasteur Australia Pty Ltd
ARTG
91355
Batches
Lot C5146B
Consent start
Consent no.
CON-75
Standard
European Pharmacopoeia
Non-compliance with standard
The product is tested to United States, rather than Australian specifications.
Conditions imposed
This consent applies only to 24000 doses from Quadracel final bulk Lot
C5146B (expiry on 2 September 2018);
Non-compliance with the European Pharmacopoeia (Ph. Eur.) requirements is
limited to the tests detailed in the application;
The doses will be labelled in the Australian approved labels (carton, vial
and package insert);
The company will provide TGA with a copy of the Release Certificate of the
above batch from US CBER;
Normal TGA lot release processes will apply to this batch.
#160;
Therapeutic product type
Prescription medicines