PRIORIX-TETRA vaccine 0.5mL powder for injection vial with diluent syringe, GlaxoSmithKline Australia Pty Ltd, CON-1170
Product name
PRIORIX-TETRA vaccine 0.5mL powder for injection vial with diluent syringe
Sponsor name
GlaxoSmithKline Australia Pty Ltd
Consent start
Consent no.
CON-1170
Standard
paragraphs 8(1)(b) and 9(1)(b) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The name of an active ingredient on the carton label does not align with the
Australian Approved Name (AAN).
Conditions imposed
Non-compliance is limited to TGO 91 requirements only,
' The non-compliant label will be revised to become fully compliant with TGO 91,
' The ingredients on medicine labels must be identified by AANs. Synonyms must
not be used in place of the approved names, and
' This exemption applies only to the product released in the Australian market
before 17 October 2025.
Therapeutic product type
Prescription medicines