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TWINRIX (combined hepatitis A hepatitis B vaccine) 1 mL injection pre-filled syringe thiomersal preservative free, GlaxoSmithKline Australia Pty Ltd, CON-443

Product name
TWINRIX (combined hepatitis A hepatitis B vaccine) 1 mL injection pre-filled syringe thiomersal preservative free
Sponsor name
GlaxoSmithKline Australia Pty Ltd
Consent start
Consent no.
CON-443
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 labels do not align with the Australian Approved Name (AAN).Excipient name on label -aluminium hydroxide,sodium phosphate - dibasic,sodium phosphate - monobasic.Excipient AAN -aluminium hydroxide hydrate,dibasic sodium phosphate heptahydrate,monobasic sodium phosphate.
Conditions imposed
1. Non-compliance with Therapeutic Goods Order 91 (TGO 91) is limited to the information detailed in the submission (PM-2020-02349-1-2);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

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