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

• Package Insert - ESPEROCT

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