Product Details for: Balfaxar

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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)
Balfaxar
Rx
002
For Injection
Intravenous
1000IU
Single-Dose Vial
351(a)
Balfaxar
Rx
Proper Name
Prothrombin complex concentrate, human-lans
BLA Number
125776
Applicant
Octapharma Pharmazeutika Produktionsges.m.b.H.
Original Approval Date
July 21, 2023
Date of First Licensure
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