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PRIORIX-TETRA vaccine 0.5mL powder for injection vial with diluent syringe, GlaxoSmithKline Australia Pty Ltd, CON-1424
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-1424
Duration
The consent is effective from 24 October 2025 until 24 October 2027.
Standard
Paragraph 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 products do not conform because the name of an active ingredient on the
carton labels, ‘varicella zoster virus’, is not consistent with the Australian
Approved Name (AAN) for the ingredient which is 'Live varicella vaccine'.
Conditions imposed
The non-compliant labels will be revised to become fully compliant with TGO 91.
This exemption applies only to the product released in the Australian market
before 24 October 2027.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines