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)Rx2026-06-01

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
ab2e1c6c-4f95-4243-9296-1734e0a305913 ML onasemnogene abeparvovec-brve 40000000000000 VECTOR-GENOMES/ML InjectionSCD1These 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
ab2e1c6c-4f95-4243-9296-1734e0a30591onasemnogene abeparvovec-brve 1.2 x 10(14) vector genomes in 3 ML InjectionPSN1These 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
ab2e1c6c-4f95-4243-9296-1734e0a30591onasemnogene abeparvovec-brve 1.2 x 10(14) vector genomes per 3 ML InjectionSY1These 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
ab2e1c6c-4f95-4243-9296-1734e0a30591onasemnogene abeparvovec-brve 4 x 10(13) vg/ML per 3 ML InjectionSY1These 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