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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-437
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-437
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 excipients names on the label, aluminium hydroxide, does not align with the
Australian Approved Name (AAN) as required by Section 6 Interpretation, name of
an excipient.
Conditions imposed
1. Non-compliance with Therapeutic Goods Order No. 91 - Standard for labels of
prescription and related medicines (TGO 91) is limited to the information
detailed in the submission (PM-2020-02340-1-2);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
Blood, tissues, and biologicals