AusPAR: Spikevax bivalent Original/Omicron BA.4-5

Australian Public Assessment Report

AusPAR

AusPAR: Spikevax bivalent Original/Omicron BA.4–5 [PDF, 1.52 MB]

AusPAR: Spikevax bivalent Original/Omicron BA.4–5 [Word, 2.2 MB]

AusPAR Attachment 1: Product Information for Spikevax bivalent Original/Omicron BA.4–5 [PDF, 649.06 KB]

AusPAR Attachment 1: Product Information for Spikevax bivalent Original/Omicron BA.4–5 [Word, 993.6 KB]

Device/Product Name

Spikevax bivalent Original/Omicron BA.4-5

Active ingredients

Elasomeran and davesomeran

AusPAR Date

24 February 2023

Published

28 February 2023

Submission Number

PM-2022-04824-1-2

Submission Type

New biological entity

Decision

Approved for provisional registration