Verorab rabies virus vaccine (inactivated) 3.25 IU powder for injection vial with diluent pre-filled syringe with attached needle, Sanofi-Aventis Australia Pty Ltd, CON-1221
Product name
Verorab rabies virus vaccine (inactivated) 3.25 IU powder for injection vial with diluent pre-filled syringe with attached needle
Sponsor name
Sanofi-Aventis Australia Pty Ltd
Batches
X1A061V
Consent start
Consent no.
CON-1221
Standard
Subparagraph 8(1)(l)(ii) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
Regarding 'Instructions for Preparation' of the product, no statement is
included on the label on the container, or the primary pack, or both, that sets
out the preparation information itself, and no physical package insert outlining
'Instructions for Preparation' will be supplied for the specific batch listed
below.
Conditions imposed
1. The product must be supplied with the labels that were previously approved,
which contain a QR code on the carton label.
2. Non-compliance with the Therapeutic Goods Order No. 91 is limited to the
information detailed in this submission.
Therapeutic product type
Prescription medicines