ESPEROCT
STN: BL 125671
Proper Name: Antihemophilic Factor (Recombinant), GlycoPEGylated-exei
Tradename: ESPEROCT
Manufacturer: Novo Nordisk, Inc.
Indication:
- For use in adults and children with hemophilia A for: (1) on-demand treatment and control of bleeding episodes, (2) perioperative management of bleeding, and (3) routine prophylaxis to reduce the frequency of bleeding episodes.
Product Information
Supporting Documents
- February 19, 2019 Approval Letter - ESPEROCT
- February 15, 2019 Summary Basis for Regulatory Action - ESPEROCT
- February 13, 2019 Clinical Review - ESPEROCT
- Statistical Review - ESPEROCT
- Approval History, Letters, Reviews, and Related Documents - ESPEROCT