The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
SPIKEVAX (elasomeran) COVID-19 VACCINE 0.2 mg/mL suspension for injection vial, Moderna Australia Pty Ltd, CON-891
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-891
Duration
The consent is effective from 10 December 2021 until 9 August 2023.
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The labels of the product do not conform to the requirements of Therapeutic
Goods Order No. 91 - Standard for labels of prescription and related medicines
(TGO 91).
Conditions imposed
The product must be supplied with the labels that were
considered and agreed to as part of the evaluation of the application dated 6
December 2021, associated email correspondence, and mock-up labels under
subsection 9D(3) of the Therapeutic Goods Act 1989, being
Samsung labels - batches R1_V7 Vial and R1_V6 Carton.
Pandemic Pack 2.0 labels - batches R2_V3 Vial and R2_V3
Carton.
Therapeutic product type
Prescription medicines