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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:  11/13/2015
 
Trade Name:  ADYNOVATE
 
Generic Name or Proper Name (*):  Antihemophilic Factor (Recombinant), PEGylated*
 
Indications Studied:  Adolescent and adult patients (12 years and older) with hemophilia A (congenital factor VIII deficiency) for (1) on-demand treatment and control of bleeding episodes and (2) routine prophylaxis to reduce the frequency of bleeding episodes
 
Label Changes Summary:  See Package Insert for new information on biologics
 
PREA(P):  P
 
Sponsor:  Baxalta US Inc.
 
NNPS:  FALSE
 
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