Product Approval Information
Proper Name: Coagulation Factor VIIa (Recombinant)
Tradename: NovoSeven
Manufacturer: Novo Nordisk Inc, License #1261
Date: March 25, 1999
Indication: Treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX
March 25, 1999 Approval Letter
Summary Basis for Approval (PDF - 589 KB)
Date: October 13, 2006
Indication: Treatment of bleeding episodes and for the prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia
October 13, 2006 Approval Letter