Spikevax (Note 2) (bivalent, Original/Omicron BA.1) (bivalent, Original/Omicron BA.4-5) (monovalent, Omicron XBB.1.5) 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 (Note 2)
(bivalent, Original/Omicron BA.1)
(bivalent, Original/Omicron BA.4-5)
(monovalent, Omicron XBB.1.5)
Partial Change Approval
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
TypeInitial Approval
Review Reports
Want structured data, translation summaries & alerts?
PharmaLens is building the most comprehensive English-language PMDA intelligence platform. Join the waitlist for early access.
Join the WaitlistSource: 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.