Product Details for: Sevenfact
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
1MG
Single-Dose Vial
351(a)
Sevenfact
Rx
002
Injection
Intravenous
5MG
Single-Dose Vial
351(a)
Sevenfact
Rx
003
Injection
Intravenous
2MG
Single-Dose Vial
351(a)
Sevenfact
Disc
Proper Name
coagulation factor VIIa (recombinant)-jncw
coagulation factor VIIa (recombinant)-jncw
BLA Number
125641
125641
Applicant
Laboratoire Francais du Fractionnement et des Biotechnologies S.A.
Laboratoire Francais du Fractionnement et des Biotechnologies S.A.
Original Approval Date
April 1, 2020
April 1, 2020
Date of First Licensure