Product Details for: Zolgensma
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
2x10^13VG/ML
Single-Dose Vial
351(a)
Zolgensma
Rx
Proper Name
onasemnogene abeparvovec-xioi
onasemnogene abeparvovec-xioi
BLA Number
125694
125694
Applicant
Novartis Gene Therapies, Inc.
Novartis Gene Therapies, Inc.
Original Approval Date
May 24, 2019
May 24, 2019
Date of First Licensure
24-May-19
24-May-19