COMIRNATY (Tozinameran [mRNA]) COVID-19 VACCINE 10 micrograms/0.2 mL concentrated suspension for injection vial, Pfizer Australia Pty Ltd, CON-887
Product name
COMIRNATY (Tozinameran [mRNA]) COVID-19 VACCINE 10 micrograms/0.2 mL concentrated suspension for injection vial
Sponsor name
Pfizer Australia Pty Ltd
Consent start
Consent no.
CON-887
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The products do not conform to the requirements of Therapeutic Goods Order No.
91 - Standard for labels of prescription and related medicines (TGO 91).
Conditions imposed
The products must be supplied with the labels that were considered and agreed to
as part of the evaluation of the application dated 15 November 2021, associated
email correspondence, and mock-up labels under section 25 of the Therapeutic
Goods Act 1989, being
* EU Labels - batches PAA173907, PAA173908, PAA181915, PAA181046,
PAA180830, PAA181041, PAA181770, PAA181911, PAA181047, PAA181044,
PAA181045.
* US Emergency Use Labels - batches PAA177913, PAA178418, PAA178420. NOTE US
Emergency Use Labels do not have the tradename (COMIRNATY), generic name
(tozinameran) or expiration date printed on the vial and/or carton labels.
Determining the actual expiry date of any vaccine supplied with these labels
will require the QR code on the carton to be scanned, followed by navigation
to the page containing the expiry information.
Therapeutic product type
Prescription medicines