ACT-HIB haemophilus type B conjugate vaccine (conjugated to tetanus protein) powder for injection vial and needle free diluent syringe, Sanofi-Aventis Australia Pty Ltd, CON-1222
Product name
ACT-HIB haemophilus type B conjugate vaccine (conjugated to tetanus protein) powder for injection vial and needle free diluent syringe
Sponsor name
Sanofi-Aventis Australia Pty Ltd
Batches
Act-HIB - 10 pack, Batch U7880AA3V
Consent start
Consent no.
CON-1222
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 batches 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