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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
 
PREA(P):  P
 
Sponsor:  Baxter
 
Therapeutic Category:  Antihemophilic Factor
 
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