FDA.reportPublic FDA data

Elahere 100 MG per 20 ML Injection

RxCUI
2621559
RxNorm name
Elahere 100 MG per 20 ML Injection
Display name
Elahere 100 MG per 20 ML Injection
Full name
Elahere 100 MG per 20 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761310Elaheremirvetuximab soravtansine-gynx351(a)Rx2026-08-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ELAHEREMIRVETUXIMAB SORAVTANSINEImmunoGen, Inc.00c424b5-6ccd-48ab-9e88-1986451120e22025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2621559

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
00c424b5-6ccd-48ab-9e88-1986451120e2ELAHERE 100 MG in 20 ML Injection [PSN] · 20 ML mirvetuximab soravtansine-gynx 5 MG/ML Injection [Elahere] [SBD] · Elahere 100 MG per 20 ML Injection [SY] · Elahere 5 MG/ML per 20 ML Injection [SY]414These highlights do not include all the information needed to use ELAHERE safely and effectively. See full prescribing information for ELAHERE. ELAHERE ® (mirvetuximab soravtansine-gynx) injection, for intravenous use . Initial U.S. Approval: 202220250714