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BEXSERO - multi-component Meningococcal B vaccine (recombinant, adsorbed) suspension for injection 0.5 ml pre-filled syringe without needle, GlaxoSmithKline Australia Pty Ltd, CON-862
Product name
BEXSERO - multi-component Meningococcal B vaccine (recombinant, adsorbed) suspension for injection 0.5 ml pre-filled syringe without needle
Sponsor name
GlaxoSmithKline Australia Pty Ltd
Consent start
Consent no.
CON-862
Duration
The consent is effective from 9 September 2021 until 23 July 2022.
Standard
Paragraph 10(3)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not comply with Paragraph 10(3)(a) of Therapeutic Goods Order
No. 91 - Standard for labels of prescription and related medicines, in that the
excipient name on the label, aluminium hydroxide, does not align with the
Australian Approved Name (AAN), aluminium hydroxide hydrate.
Conditions imposed
1. Non-compliance with Therapeutic Goods Order 91 (TGO 91) is limited to the
information detailed in the submission.
2. The non-compliant label will be revised to become fully compliant with TGO
91 on or before 23 July 2022.
3. This exemption applies only to products released in the Australian market
before 23 July 2022.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines