SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial (389513)

ARTG ID 389513

ARTG Name

SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial

Product name

SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial

ARTG Date

30 August 2022

Registration Type

Medicine

Therapeutic good type

M

Ingredients

elasomeran

imelasomeran

Licence category

REP

Licence status

A

Summary

Product information

Consumer medicine information

Related information

18 October 2022

Section 14 consent

Moderna Australia Pty Ltd, from CON-1017, SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial

Approved for Import and supply while noncompliant with standards. The consent is effective from 18 October 2022 until 29 August 2024
23 November 2022

Section 14 consent

Seqirus Pty Ltd, from CON-1038, <div class="ExternalClass5E566A195976499C988E7EB691AF44C0">SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial</div>

Approved for Import and supply while noncompliant with standards. <div class="ExternalClass713E079714E340859C9A8B0AEFCF1C19">The consent is effective from 23 November 2022 until 23 November 2023.</div>
23 November 2022

Section 14 consent

Seqirus Pty Ltd, from CON-1038, <div class="ExternalClassFE04EFCBCACD4A1E9FA9946703607DEB">SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial</div>

Approved for Import and supply while noncompliant with standards. <div class="ExternalClass713E079714E340859C9A8B0AEFCF1C19">The consent is effective from 23 November 2022 until 23 November 2023.</div>