Product Details for: Kanuma
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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)
Kanuma
Rx
Proper Name
sebelipase alfa
sebelipase alfa
BLA Number
125561
125561
Applicant
Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Original Approval Date
December 8, 2015
December 8, 2015
Date of First Licensure