STN: BL 125466
Proper Name: Antihemophilic Factor (Recombinant)
Tradename: Novoeight
Manufacturer: Novo Nordisk 

Indication: 

• For adults, adolescents, and children with hemophilia A for (1) the control and prevention of bleeding episodes, (2) perioperative management, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Product Information

• Package Insert - Novoeight

Supporting Document

• November 30, 2018 Approval Letter - Novoeight
• November 30, 2018 Summary Basis for Regulatory Action - Novoeight
• Supporting Documents older than three years - Novoeight
• Approval History, Letters, Reviews and Related Documents - Novoeight