SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial, Adjutor Healthcare Pty Ltd (on behalf of Moderna Australia Pty Ltd), CON-1077
Product name
SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial
Sponsor name
Adjutor Healthcare Pty Ltd (on behalf of Moderna Australia Pty Ltd)
ARTG
389513
Consent start
Consent no.
CON-1077
Standard
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
1. The product must be supplied with the labels that were considered and agreed
to as part of the evaluation under section 9D(3) of the Therapeutic Goods Act
1989, being the 'International Labels', suspension for injection vial and carton
labels, for the drug product referred to in submission. as follows: a) SPIKEVAX
BIVALENT ORIGINAL/OMICRON 2.5 mL Carton Samsung 5501801 b) SPIKEVAX BIVALENT
ORIGINAL/OMICRON 2.5 mL Label Samsung 5501701 c) SPIKEVAX BIVALENT
ORIGINAL/OMICRON 2.5 mL Label Samsung 30001
Therapeutic product type
Prescription medicines