Novoeight
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
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