Product Details for: Wilate
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PRODUCT LABEL
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
500IU
Single-Dose Vial
351(a)
Wilate
Rx
002
For Injection
Intravenous
1000IU
Single-Dose Vial
351(a)
Wilate
Rx
Proper Name
von Willebrand Factor/Coagulation Factor VIII Complex (Human)
von Willebrand Factor/Coagulation Factor VIII Complex (Human)
BLA Number
125251
125251
Applicant
Octapharma Pharmazeutika Produktionsges.m.b.H.
Octapharma Pharmazeutika Produktionsges.m.b.H.
Original Approval Date
December 20, 2010
December 20, 2010
Date of First Licensure