FDA.reportPublic FDA data

10 ML sebelipase alfa 2 MG/ML Injection [Kanuma]

RxCUI
1726984
RxNorm name
10 ML sebelipase alfa 2 MG/ML Injection [Kanuma]
Display name
10 ML sebelipase alfa 2 MG/ML Injection [Kanuma]
Full name
10 ML sebelipase alfa 2 MG/ML Injection [Kanuma]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:06

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125561Kanumasebelipase alfa351(a)Rx2026-09-01

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.

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
83a77b9d-42f0-4645-8420-786285da7326Kanuma 20 MG in 10 ML Injection [PSN] · 10 ML sebelipase alfa 2 MG/ML Injection [Kanuma] [SBD] · 10 ML Kanuma 2 MG/ML Injection [SY] · Kanuma 20 MG per 10 ML Injection [SY]411These highlights do not include all the information needed to use KANUMA safely and effectively. See full prescribing information for KANUMA. KANUMA (sebelipase alfa) injection, for intravenous use Initial U.S. Approval: 201520250721