STN: BL 125487
Proper Name: Antihemophilic Factor (Recombinant), FcFusion Protein
Manufacturer: Biogen Idec, Inc.
- For adults and children with Hemophilia A for (1) on-demand treatment and control of bleeding episodes, (2) perioperative management, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
- Clinical Review - ELOCTATE
- January 8, 2016 Approval Letter - ELOCTATE
To support labeling changes based on additional final efficacy.
- Supporting Documents older than three years - ELOCTATE
- Approval History, Letters, Reviews and Related Documents - Eloctate