COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial, Pfizer Australia Pty Ltd, CON-746
Product name
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial
Sponsor name
Pfizer Australia Pty Ltd
ARTG
346290
Consent start
Consent no.
CON-746
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 Therapeutic Goods Order No. 91 - Standard for
labels of prescription and related medicines (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 the 'US emergency use
labels' for 5 doses per vial as follows i. Carton label; ii. Vial
label. b) The international label, referred to here as the
'COMIRNATY-branded labels' for 5 doses per vial as follows i. Carton
label; ii. Vial label. c) The international label, referred to here as
the 'EU labels' for 6 doses per vial as follows i. Carton label 'Made in
Germany'; ii. Carton label; iii. Vial label. d) The international
label, referred to here as the 'COMIRNATY-branded labels' for 6 doses per vial
as follows i. Carton label; ii. Vial label.
Therapeutic product type
Prescription medicines