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SPIKEVAX (elasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial, Moderna Australia Pty Ltd, CON-984
Product name
SPIKEVAX (elasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial
Sponsor name
Moderna Australia Pty Ltd
Consent start
Consent no.
CON-984
Duration
The consent is effective from 29 August 2022 until 15 July 2024
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91).
Non-compliance with standard
The carton and vial labels are supplied with ‘International Labels’ which do not
comply with Therapeutic Goods Order No. 91 - Standard for labels of prescription
and related medicines (TGO 91)
Conditions imposed
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
a) The ‘International Labels’, vial and carton labels, for drug product
manufactured at Catalent Indiana LLC, referred to in submission as follows
i. Vial label for the 0.1 mg/mL suspension for injection vial
ii. Carton label for the 0.1 mg/mL suspension for injection vial
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines