ESPEROCT
STN: BL 125671/197
Proper Name: Antihemophilic Factor (Recombinant), GlycoPEGylated-exei
Tradename: Esperoct
Manufacturer: Novo Nordisk, Inc.
Indication:
- Adults and children with hemophilia A for control and prevention of bleeding, perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes.
Product Information
Supporting Documents
- February 28, 2024 Approval Letter - ESPEROCT
- 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