PRIORIX-TETRA vaccine 0.5 mL powder for injection vial with diluent syringe, GlaxoSmithKline Australia Pty Ltd, CON-775
Product name
PRIORIX-TETRA vaccine 0.5 mL powder for injection vial with diluent syringe
Sponsor name
GlaxoSmithKline Australia Pty Ltd
Consent start
Consent no.
CON-775
Standard
Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does not conform to the requirements of TGO 91 Section 6 and
Subsection 10(3), in that the excipients names on the labels do not align with
the AAN and the quantity of all excipients is not specified on the label.
Conditions imposed
Non-compliance is limited to TGO 91 requirements only.
Therapeutic product type
Prescription medicines