COMIRNATY (tozinameran [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial, Pfizer Australia Pty Ltd, CON-890
Product name
COMIRNATY (tozinameran [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-890
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 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 of the application dated 1
November 2021, associated email correspondence, and mock-up labels under
subsection 9D(3) of the Therapeutic Goods Act 1989, being
EU Labels - batches PAA182622 and PAA182621.
Therapeutic product type
Prescription medicines