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

• Package Insert - ESPEROCT

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