Product Details for: Roctavian

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
16X 10E13GENOMES PER ML
Single-Dose Vial
351(a)
Roctavian
Disc
Proper Name
valoctocogene roxaparvovec-rvox
BLA Number
125720
Applicant
Biomarin Pharmaceutical Inc.
Original Approval Date
June 29, 2023
Date of First Licensure
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