PRIORIX-TETRA vaccine 0.5 mL powder for injection vial with diluent syringe, GlaxoSmithKline Australia Pty Ltd, CON-1082
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-1082
Standard
Section 6 and paragraph 10(3)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The excipient names on the labels do not align with the Australian Approved
Names and the quantity of all excipients is not specified on the label.
Therapeutic product type
Prescription medicines