Spikevax (bivalent, Original/Omicron BA.4-5)

(Note 2)Partial Change Approval

Coronavirus (SARS-CoV-2) RNA Vaccine (active ingredients: elasomeran and davesomeran)

Approval Information

Brand NameSpikevax (bivalent, Original/Omicron BA.4-5)

Generic NameCoronavirus (SARS-CoV-2) RNA Vaccine (active ingredients: elasomeran and davesomeran)

ApprovedAugust 2023

Type(Note 2)Partial Change Approval

Review Reports

English Review Report

PDF · 832.26 KB

Japanese Review Report

PDF · 709.97 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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