SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial, Moderna Australia Pty Ltd, CON-1017
Product name
SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial
Sponsor name
Moderna Australia Pty Ltd
ARTG
389513
Consent start
Consent no.
CON-1017
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91).
Non-compliance with standard
The product is non-compliant with TGO91 in that the labels are international
labels.
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 the 'International Labels', vial and carton labels, for
drug product referred to in submission PM-2022-03959-1-2 as follows:
> a) Drug product manufactured at Catalent Indiana LLCi. 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
>
>
>
>
> b) Drug product manufactured at Rovi Pharma Industrial Services, S.A.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
> c) Drug product manufactured at Samsung Biologics Co. Ltd. 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
Therapeutic product type
Prescription medicines