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Product Approval Information - Licensing Action

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Proper name: Coagulation Factor VIIa (Recombinant)
Tradename: NovoSeven
Manufacturer: Novo Nordisk A/S, Denmark, License #1261
Indication for Use: Treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX
Approval Date: 3/25/99
Type of submission: Biologics license application

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Approval Letter - (PDF), (Text)

Label - (PDF)

SBA - (PDF)

 

Updated March 6, 2001
 
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