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Vaccines, Blood & Biologics

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NovoSeven

Proper Name: Coagulation Factor VIIa (Recombinant)
Tradename: NovoSeven
Manufacturer: Novo Nordisk Inc, License #1261

Package Insert (PDF - 238 KB)


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

    
 

Contact Us

  • Consumer Affairs Branch (CBER)

  • (800) 835-4709
  • (301) 827-1800
  • Division of Communication and Consumer Affairs

    Office of Communication, Outreach and Development

    Food and Drug Administration

    1401 Rockville Pike

    Suite 200N/HFM-47

    Rockville, MD 20852-1448

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