FDA.reportPublic FDA data

mRESVIA 50 MCG in 0.5 ML Prefilled Syringe

RxCUI
2685012
RxNorm name
mRESVIA 50 MCG in 0.5 ML Prefilled Syringe
Display name
mRESVIA 50 MCG in 0.5 ML Prefilled Syringe
Full name
mRESVIA 50 MCG in 0.5 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:25

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125796mresviaRespiratory Syncytial Virus Vaccine351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
e5c837e7-41e8-496a-9c85-6b0453b35948mRESVIA 50 MCG in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML respiratory syncytial virus pre-fusion F glycoprotein mRNA 0.1 MG/ML Prefilled Syringe [Mresvia] [SBD] · 0.5 ML Mresvia 0.1 MG/ML Prefilled Syringe [SY] · mRESVIA 50 MCG per 0.5 ML Prefilled Syringe [SY]45These highlights do not include all the information needed to use MRESVIA safely and effectively. See full prescribing information for MRESVIA . MRESVIA TM (Respiratory Syncytial Virus Vaccine) injectable suspension, for intramuscular use Initial U.S. Approval: 202420250612