QUADRACEL 0.5 mL injection vial, Sanofi Aventis Australia Pty Ltd, CON-118
Product name
QUADRACEL 0.5 mL injection vial
Sponsor name
Sanofi Aventis Australia Pty Ltd
ARTG
91355
Batches
C5146BD
Consent start
Consent no.
CON-118
Standard
Does not conform with the requirements of the European Pharmacopoeia.
Non-compliance with standard
It is tested to the United States, rather than Australian specifications, as
detailed in the application letter.
Conditions imposed
This consent applies only to 24725 doses from Quadracel batch C5146BD;
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 batch release processes will apply to this batch.
Therapeutic product type
Prescription medicines