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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:  05/25/2016
 
Trade Name:  AFSTYLA
 
Generic Name or Proper Name (*):  Antihemophilic Factor (Recombinant), Single Chain*
 
Indications Studied:  Indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for: (1) On-demand treatment and control of bleeding episodes, (2) Routine prophylaxis to reduce the frequency of bleeding episodes, and (3) Perioperative management of bleeding
 
Label Changes Summary:  See Package Insert for new information on biologics
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  CSL Behring AG
 
NNPS:  FALSE
 
Therapeutic Category:  Antihemophilic Factor
 
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