Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
COMIRNATY (tozinameran) COVID-19 VACCINE 10 micrograms/0.2 mL concentrated suspension for injection vial, Pfizer Australia Pty Ltd, CON-1096
Product name
COMIRNATY (tozinameran) COVID-19 VACCINE 10 micrograms/0.2 mL concentrated suspension for injection vial
Sponsor name
Pfizer Australia Pty Ltd
Consent start
Consent no.
CON-1096
Standard
multiple sections of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Conditions imposed
-The product must be supplied with the alternative carton labels that were
considered and agreed to as part of the evaluation under section 9D(3) of the
Therapeutic Goods Act 1989
- a Dear Healthcare Professional Letter will be distributed with the product
providing information to the prescribers of different presentations of the
vaccine available, including how to differentiate them and what each is for.
Therapeutic product type
Prescription medicines