Pfizer Australia Pty Ltd, from CON-887, COMIRNATY (Tozinameran [mRNA]) COVID-19 VACCINE 10 micrograms/0.2 mL concentrated suspension for injection vial
COMIRNATY (Tozinameran [mRNA]) COVID-19 VACCINE 10 micrograms/0.2 mL concentrated suspension for injection vial
Pfizer Australia Pty Ltd
The consent is effective from 6 December 2021 until 3 December 2023.
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Supply/Import or Export
Therapeutic good type
- 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.
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).