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Itvisma
onasemnogene abeparvovec-brve
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Itvisma
Proper name
onasemnogene abeparvovec-brve
Licence type
351(a)
BLA number
125856
Applicant
Novartis Gene Therapies, Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 4x10^13VG/ML | Injection | Intrathecal | Single-Dose Vial | Rx | November 24, 2025 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |