Product Details for: Kanuma

RETURN TO SEARCH RESULTS
PRODUCT LABEL Grayed out Product Label links indicate that there is no product label available for the product.
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
BLA Number
125561
Applicant
Alexion Pharmaceuticals, Inc.
Original Approval Date
December 8, 2015
Date of First Licensure