Vaccines, Blood & Biologics
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NovoSeven
STN: BL 103665
Proper Name: Coagulation Factor VIIa (Recombinant)
Tradename: NovoSeven
Manufacturer: Novo Nordisk Inc, License #1261
Indication: Treatment of bleeding episodes and for the prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia.
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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 IXSummary 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
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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.
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