Product Details for: ITVISMA

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intrathecal
4x10^13VG/ML
Single-Dose Vial
351(a)
ITVISMA
Rx
Proper Name
onasemnogene abeparvovec-brve
BLA Number
125856
Applicant
Novartis Gene Therapies, Inc.
Original Approval Date
November 24, 2025
Date of First Licensure
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