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COMIRNATY ORIGINAL/OMICRON BA.4-5 (tozinameran/famtozinameran) COVID-19 VACCINE 1.5/1.5 micrograms/0.2 mL concentrated suspension for injection vial, Pfizer Australia Pty Ltd, CON-1305
Product name
COMIRNATY ORIGINAL/OMICRON BA.4-5 (tozinameran/famtozinameran) COVID-19 VACCINE 1.5/1.5 micrograms/0.2 mL concentrated suspension for injection vial
Sponsor name
Pfizer Australia Pty Ltd
Consent start
Consent no.
CON-1305
Duration
The consent is effective from 9 December 2024 until 1 October 2026.
Standard
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not comply with TGO 91 in that: • A machine-readable code has
not been assigned to the carton labels; • The name and strength of the active
ingredients are not displayed together in separate lines and are not placed
immediately below the name of the medicine on the carton labels; • The batch
number and expiry date on the vial labels are prefixed with ‘Lot/Exp’, which
does not align with the Section 6 Interpretation for batch number and expiry
date prefixes.
Conditions imposed
A Dear Healthcare Professional Letter will be distributed, providing information
to the prescribers of different presentations of the vaccine available,
including how to differentiate them and what each is for.
The product must be supplied with the labels that were submitted and evaluated
by the TGA.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Blood, tissues, and biologicals