BeneFIX
STN: BL 103677
Proper Name:Coagulation Factor IX (Recombinant)
Tradename: BeneFIX
Manufacturer: Wyeth Pharmaceuticals LLC
Indication:
BeneFIX is a recombinant human blood coagulation factor IX indicated for the treatment of:
- Adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for:
- On-demand treatment and control of bleeding episodes
- Perioperative management of bleeding
- Adults with hemophilia B (congenital factor IX deficiency or Christmas disease) for:
- Routine prophylaxis to reduce the frequency of bleeding episodes
Product Information
Supporting Documents
- February 17, 2021 Partial Rescission of Approval - BeneFIX
- June 26, 2020 Approval Letter - BeneFIX
- Supporting Documents older than three years - BeneFIX