FDA.reportPublic FDA data

3 ML onasemnogene abeparvovec-brve 40000000000000 VECTOR-GENOMES/ML Injection

RxCUI
2727307
RxNorm name
3 ML onasemnogene abeparvovec-brve 40000000000000 VECTOR-GENOMES/ML Injection
Display name
3 ML onasemnogene abeparvovec-brve 40000000000000 VECTOR-GENOMES/ML Injection
Full name
3 ML onasemnogene abeparvovec-brve 40000000000000 VECTOR-GENOMES/ML Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:15

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125856ITVISMAonasemnogene abeparvovec-brve351(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.

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
ITVISMAONASEMNOGENE ABEPARVOVEC-BRVENovartis Innovative Technologies Inc.ab2e1c6c-4f95-4243-9296-1734e0a305912026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2727307

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
ab2e1c6c-4f95-4243-9296-1734e0a30591onasemnogene abeparvovec-brve 1.2 x 10(14) vector genomes in 3 ML Injection [PSN] · 3 ML onasemnogene abeparvovec-brve 40000000000000 VECTOR-GENOMES/ML Injection [SCD] · onasemnogene abeparvovec-brve 1.2 x 10(14) vector genomes per 3 ML Injection [SY] · onasemnogene abeparvovec-brve 4 x 10(13) vg/ML per 3 ML Injection [SY]41These highlights do not include all the information needed to use ITVISMA safely and effectively. See full prescribing information for ITVISMA. ITVISMA ® (onasemnogene abeparvovec-brve) suspension, for intrathecal injection Initial U.S. Approval: 202520251124