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

• Package Insert -  SEVENFACT

Supporting Documents

• 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