Product Details for: Berinert
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
500U
Single-Dose Vial
351(a)
Berinert
Rx
Proper Name
C1 Esterase Inhibitor (Human)
C1 Esterase Inhibitor (Human)
BLA Number
125287
125287
Applicant
CSL Behring GmbH
CSL Behring GmbH
Original Approval Date
October 9, 2009
October 9, 2009
Date of First Licensure