Product Information

• NovoSeven, Package Insert (PDF - 238 KB) (PDF - 238KB)

Supporting Documents

• March 25, 1999 Approval Letter - NovoSeven
  Indication: Treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX
• Summary Basis for Approval (PDF - 589 KB)  (PDF - 580KB)
• October 13, 2006 Approval Letter - NovoSeven
  Indication: Treatment of bleeding episodes and for the prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia

Related Information

• FDA Online Label Repository
  Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.

Contact FDA