TWINRIX JUNIOR (combined hepatitis A hepatitis B vaccine) 0.5 mL injection pre-filled syringe thiomersal preservative free, GlaxoSmithKline Australia Pty Ltd, CON-443
Product name
TWINRIX JUNIOR (combined hepatitis A hepatitis B vaccine) 0.5 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