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-305
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
Consent start
Consent no.
CON-305
Standard
Paragraph 8(1)(o) of Therapeutic Goods Order No 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The carton labels for the 1's and 10's packs of the product do not have the name
of the medicine on at least three non-opposing sides.
Conditions imposed
The conditions on that consent are as followsNon-compliance with TGO 91 is
limited to the information detailed in the submission (PM-2018-04855-1-2)The
non-compliant labels will be revised to become fully compliant with TGO 91 on or
before 1 September 2020. This exemption applies only to batches released in the
Australian market before 1 September 2020
Therapeutic product type
Prescription medicines