COMIRNATY JN.1 (bretovameran) COVID-19 VACCINE 30 micrograms/0.3 mL suspension for injection multidose vial, Pfizer Australia Pty Ltd, CON-1401

The product labels do not comply because: • ARTG number is not in the required text size on the label; • The interim Australian Biological Name (ABN) is not shown on the label; • Only dose per strength of the active ingredient is displayed on the labels; • Only single dose volume is displayed on the 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; • The name and contact details of the Australian sponsor is not displayed on the labels; • Relevant warning statements, where these are required in relation to a particular medicine are not included; • 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 name and quantity of each excipient in the medicine is not expressed on the labels; • The vaccine formulation does not contain an antimicrobial preservative, nor a statement on the label ‘Use in one patient on one occasion only. Contains no antimicrobial preservative’; • The weight of the active ingredient in a stated volume of medicine is not expressed on the labels; • The potency is not stated on the labels.