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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:  03/16/2016
 
Trade Name:  KOVALTRY
 
Generic Name or Proper Name (*):  Antihemophilic Factor (Recombinant), Full Length*
 
Indications Studied:  "Indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for: • On-demand treatment and control of bleeding episodes • Perioperative management of bleeding • Routine prophylaxis to reduce the frequency of bleeding episodes"
 
Label Changes Summary:  See Package Insert for new information on biologics
 
PREA(P):  P
 
Sponsor:  Bayer HealthCare LLC
 
NNPS:  FALSE
 
Therapeutic Category:  Antihemophilic Factor
 
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