SEVENFACT
BL: 125641
Proper Name: coagulation factor VIIa (recombinant)-jncw
Tradename: SEVENFACT
Manufacturer: Laboratoire Francais du Fractionnement et des Biotechnologies S.A. (LFB S.A)
Indication:
- Treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors.
Product Information
Supporting Documents
- Clinical Review Memo of Labeling Supplement – SEVENFACT
- November 22, 2022 Approval Letter - SEVENFACT
- Summary Basis for Regulatory Action - SEVENFACT
- April 1, 2020 Approval Letter -SEVENFACT
- Clinical Review Memo - SEVENFACT
- Statistical Review - SEVENFACT
- Approval History, Letters, Reviews, and Related Documents - SEVENFACT