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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:  08/29/2018
 
Trade Name:  JIVI
 
Generic Name or Proper Name (*):  Antihemophilic Factor (Recombinant), PEGylated-aucl*
 
Indications Studied:  Use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for: on demand treatment and control of bleeding episodes; perioperative management of bleeding; and routine prophylaxis to reduce the frequency of bleeding episodes
 
Label Changes Summary:  See Package Insert for new information on biologics
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bayer HealthCare, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antihemophilic Factor
 
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