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PRIORIX-TETRA vaccine 0.5mL powder for injection vial with diluent syringe, GlaxoSmithKline Australia Pty Ltd, CON-431
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-431
Standard
Paragraph 10(3)(a) in the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The excipient name on the label, lactose, does not align with the Australian
Approved Name (AAN).
Conditions imposed
1. Non-compliance with Therapeutic Goods Order 91 (TGO 91) is limited to the
information detailed in the submission (PM-2020-02348-1-2);2. The non-compliant
labels will be revised to become fully compliant with TGO 91 on or before 11 May
2021; and3. This exemption applies only to product released in the Australian
market before 11 May 2021.
Therapeutic product type
Prescription medicines