Spikevax (bivalent, Original/Omicron BA.1) (bivalent, Original/Omicron BA.4-5) (monovalent, Omicron XBB.1.5)

(Note 2)Partial Change Approval

Coronavirus (SARS-CoV-2) RNA Vaccine (active ingredients of bivalent Original/Omicron BA.1 vaccine: elasomeran and imelasomeran) (active ingredients of bivalent Original/Omicron BA.4-5 vaccine: elasomeran and davesomeran) (active ingredient of monovalent Omicron XBB.1.5 vaccine: andusomeran)

Approval Information

Brand NameSpikevax (bivalent, Original/Omicron BA.1) (bivalent, Original/Omicron BA.4-5) (monovalent, Omicron XBB.1.5)

Generic NameCoronavirus (SARS-CoV-2) RNA Vaccine (active ingredients of bivalent Original/Omicron BA.1 vaccine: elasomeran and imelasomeran) (active ingredients of bivalent Original/Omicron BA.4-5 vaccine: elasomeran and davesomeran) (active ingredient of monovalent Omicron XBB.1.5 vaccine: andusomeran)

ApprovedOctober 2023

Type(Note 2)Partial Change Approval

Review Reports

English Review Report

PDF · 661.87 KB

Japanese Review Report

PDF · 773.31 KB

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Source: PMDA Website. Review reports are provided under Japan's Public Data License v1.0. Translations and structured data by PharmaLens are unofficial and for reference only.

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