Coagulation Factor VIIa Recombinant Human
Drug Details
- Generic Name
- Coagulation Factor VIIa Recombinant Human
- Brand Names
- Sevenfact
- Application Number
- BLA125641
- Sponsor
- Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.)
- NDC Codes
- 3
- Dosage Forms
- KIT
- Routes
- INTRAVENOUS
- Active Ingredients
- N/A
Indications and Usage
1 INDICATIONS AND USAGE SEVENFACT is indicated 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. Limitation s of Use: SEVENFACT is not indicated for the treatment of patients with congenital Factor VII deficiency. SEVENFACT is a coagulation factor VIIa concentrate indicated 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 ( 1 ). Limitation s of Use: SEVENFACT is not indicated for treatment of congenital factor VII deficiency.