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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  12/14/2011
Trade Name:  Advate
Generic Name or Proper Name (*):  Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method*
Indications Studied:  Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with hemophilia A
Label Changes Summary:  See Package Insert for new information on biologics
Product Labeling:  Labeling  Opens a new window
Sponsor:  Baxter
Therapeutic Category:  Antihemophilic Factor