SEVENFACT
BL: 125641
Proper Name: coagulation factor VIIa (recombinant)-jncw
Tradename: SEVENFACT
Manufacturer: LFB S.A.
Indication:
- For the treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors.
- June 20, 2024 Approval Letter - SEVENFACT
- 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