Spikevax (bivalent, Original/Omicron BA.1)

(Note 2)Partial Change Approval

Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredients: elasomeran and imelasomeran)

Approval Information

Brand NameSpikevax (bivalent, Original/Omicron BA.1)

Generic NameCoronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredients: elasomeran and imelasomeran)

ApprovedSeptember 2022

Type(Note 2)Partial Change Approval

Review Reports

English Review Report

PDF · 548.93 KB

Japanese Review Report (1)

PDF · 731.89 KB

Japanese Review Report (2)

PDF · 118.67 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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