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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-1069
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 details
- 389513
Consent start
Consent no.
CON-1069
Duration
The consent is effective from 22 February 2023 until 29 August 2024.
Standard
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products are supplied with International Labels
Conditions imposed
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.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines