FDA.reportPublic FDA data

respiratory syncytial virus pre-fusion F glycoprotein mRNA 50 MCG per 0.5 ML Prefilled Syringe

RxCUI
2685006
RxNorm name
respiratory syncytial virus pre-fusion F glycoprotein mRNA 50 MCG per 0.5 ML Prefilled Syringe
Display name
respiratory syncytial virus pre-fusion F glycoprotein mRNA 50 MCG per 0.5 ML Prefilled Syringe
Full name
respiratory syncytial virus pre-fusion F glycoprotein mRNA 50 MCG per 0.5 ML Prefilled Syringe
Term type
SY
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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UNII Substances#

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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-9c85-6b0453b35948respiratory syncytial virus pre-fusion F glycoprotein mRNA 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 [SCD] · respiratory syncytial virus pre-fusion F glycoprotein mRNA 50 MCG per 0.5 ML Prefilled Syringe [SY]35These 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