SPIKEVAX (elasomeran) COVID-19 VACCINE 0.2 mg/mL suspension for injection vial, Moderna Australia Pty Ltd, CON-960
Product name
SPIKEVAX (elasomeran) COVID-19 VACCINE 0.2 mg/mL suspension for injection vial
Sponsor name
Moderna Australia Pty Ltd
Consent start
Consent no.
CON-960
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91).
Non-compliance with standard
The product does not comply with TGO 91. Therapeutic Goods Order No. 91 -
Standard for labels of prescription and related medicines (TGO 91) in that the
carton labels are 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, as stated in the letter of consent, dated 24 June 2022.
Therapeutic product type
Prescription medicines