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PRIORIX ALBUMIN FREE VACCINE 0.5 mL powder for injection vial and diluent syringe, GlaxoSmithKline Australia Pty Ltd, CON-1086
Product name
PRIORIX ALBUMIN FREE VACCINE 0.5 mL powder for injection vial and diluent syringe
Sponsor name
GlaxoSmithKline Australia Pty Ltd
Consent start
Consent no.
CON-1086
Duration
The consent is effective from 9 March 2023 until 1 October 2026
Standard
Section 6 and Subsection 10(3) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
the excipient names on the labels do not align with the AAN and the quantity of
all excipients is not specified on the label as detailed below: Names of all
fifteen ingredients and their quantity should be included on the label.
Conditions imposed
Non-compliance is limited to TGO 91 requirements only.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines