BOOSTRIX 0.5 mL injection pre-filled syringe, GlaxoSmithKline Australia Pty Ltd, CON-442
Product name
BOOSTRIX 0.5 mL injection pre-filled syringe
Sponsor name
GlaxoSmithKline Australia Pty Ltd
Consent start
Consent no.
CON-442
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 does not align with the Australian Approved Name
(AAN).Excipient name on label isaluminium hydroxide, excipient AANaluminium
hydroxide hydrate.
Conditions imposed
1. Non-compliance with Therapeutic Goods Order 91 (TGO 91) is limited to the
information detailed in the submission (PM-2020-02344-1-2);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