COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection 5mL multidose vial, AstraZeneca Pty Ltd, CON-765
Product name
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection 5mL multidose vial
Sponsor name
AstraZeneca Pty Ltd
ARTG
349072
Batches
The consent is for all batches manufactured utilizing the 'UK labels' for 8 doses per vial.
Consent start
Consent no.
CON-765
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The labels of the product do not conform to 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 the international label, referred to here as 'UK labels' for 8 doses per
vial, as follows Carton label (UK Wockhardt);Vial label (UK Wockhardt).
Therapeutic product type
Prescription medicines