Antihemophilic Factor definition

Antihemophilic Factor means the MAA-approved exogenous recombinant antihemophilic factor (i.e., rFVIII) labeled for use in the Field and administered by or on behalf of Bayer, its Affiliates or Sublicensees to a patient for prophylactic and non-interventional purposes.
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Antihemophilic Factor means any blood product (including, but not lim- ited to, fresh frozen plasma, cryoprecipitate, factor VIII con- centrate, and factor IX concentrate) used to treat a blood-clotting disorder.
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Examples of Antihemophilic Factor in a sentence

  • Armour Blood Products Litigation Legal proceedings remain pending in the U.S. and Ireland against Armour Pharmaceutical Company in which individuals with hemophilia and infected with HIV claim that such infection was caused by administration of plasma-derived AHF (Antihemophilic Factor) concentrates processed in the late 1970s to mid-1980s.

  • Recombinant product growth was fueled by strong demand for Recombinate Antihemophilic Factor (rAHF) (Recombinate), as well as the launch of the advanced recombinant therapy, ADVATE (Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method) rAHF-PFM (ADVATE), which received regulatory approval in the United States in July 2003.

  • Key drivers of this performance include robust growth of antibody therapies and other specialty plasma therapeutics, strong sales of recombinant therapies, including ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] for the treatment of hemophilia, as well as biosurgery products.

  • Driving this performance was robust demand for products used for the treatment of hemophilia and immune disorders, including ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] and GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] (marketed as KIOVIG outside of the United States), as well as for other specialty plasma-based therapeutics and select biosurgery products.

  • Recombinant sales totaled $1.3 billion in 2004, an increase of 18 percent over 2003, and included $286 million in sales of ADVATE® Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM), which has now been launched in the U.S. and 12 European countries.

  • We have received and responded to questions from the regulatory agencies and continue to expect ADVATE (Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method) rAHF-PFM approval in the second half of 2003.

  • Partially offsetting this decline was continued growth of ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] for the treatment of hemophilia and ARALAST NP [Alpha 1-Proteinase Inhibitor (Human)] for the treatment of hereditary emphysema, as well as strong sales of biosurgery products.

  • Driving this performance was robust growth in demand, particularly in the United States, for ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method], and GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)], as well as other plasma-based therapeutics including FEIBA, an inhibitor bypass therapy, and albumin.

  • Bioverativ’s extended half-life therapies, Eloctate® [Antihemophilic Factor VIII (Recombinant), Fc Fusion Protein] and Alprolix® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] for the treatment of hemophilia A and B, respectively, represented the first major advancements in the hemophilia market in nearly two decades when launched.

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