Product Details for: Elfabrio

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
20MG/10ML (2MG/ML)
Single-Dose Vial
351(a)
Elfabrio
Rx
002
Injection
Intravenous
5MG/2.5ML
Single-Dose Vial
351(a)
Elfabrio
Rx
Proper Name
pegunigalsidase alfa-iwxj
BLA Number
761161
Applicant
Chiesi Farmaceutici S.p.A.
Original Approval Date
May 9, 2023
Date of First Licensure
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