FDA.reportPublic FDA data

sutimlimab-jome 1100 MG in 22 ML Injection

RxCUI
2591419
RxNorm name
sutimlimab-jome 1100 MG in 22 ML Injection
Display name
sutimlimab-jome 1100 MG in 22 ML Injection
Full name
sutimlimab-jome 1100 MG in 22 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:51

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761164Enjaymosutimlimab-jome351(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
EnjaymoSUTIMLIMAB-JOMERecordati Rare Diseases, Inc.0a25363a-7781-d9f8-cb1c-be22987bf03b2026-03-02Warnings, Adverse reactionsExact identifier
rxcui: 2591419

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
281cf1d4-6296-4416-858e-9bff46d01b71sutimlimab-jome 1100 MG in 22 ML Injection [PSN] · 22 ML sutimlimab-jome 50 MG/ML Injection [SCD] · sutimlimab-jome 1100 MG per 22 ML Injection [SY]310These highlights do not include all the information needed to use ENJAYMO safely and effectively. See full prescribing information for ENJAYMO. ENJAYMO ® (sutimlimab-jome) injection, for intravenous use Initial U.S. Approval: 202220240221
0a25363a-7781-d9f8-cb1c-be22987bf03bsutimlimab-jome 1100 MG in 22 ML Injection [PSN] · 22 ML sutimlimab-jome 50 MG/ML Injection [SCD] · sutimlimab-jome 1100 MG per 22 ML Injection [SY]34These highlights do not include all the information needed to use ENJAYMO safely and effectively. See full prescribing information for ENJAYMO. ENJAYMO ® (sutimlimab-jome) injection, for intravenous use Initial U.S. Approval: 202220260302