COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection 5mL multidose vial, AstraZeneca Pty Ltd, CON-754
Product name
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection 5mL multidose vial
Sponsor name
AstraZeneca Pty Ltd
ARTG
349072
Consent start
Consent no.
CON-754
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does not comply with TGO 91.
Conditions imposed
The product must be supplied with the labels that were considered and
agreed to as part of the evaluation under section 25 of the Therapeutic Goods
Act 1989, being
a) The international label, referred to here as 'EU labels' for 10 doses
per vial, as follows i. Carton label ii. Vial label iii. Stickers
Therapeutic product type
Prescription medicines