Product Details for: Fayuvi

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Suspension
Intravenous
1.0x10^13VG/ML
Single-Dose Vial
351(a)
Fayuvi
Rx
Proper Name
rebisufligene etisparvovec-hopf
BLA Number
125845
Applicant
Ultragenyx Pharmaceutical Inc.
Original Approval Date
September 17, 2026
Date of First Licensure
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