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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:  02/19/2019
 
Trade Name:  ESPEROCT
 
Generic Name or Proper Name (*):  Antihemophilic Factor (Recombinant), GlycoPEGylated-exei*
 
Indications Studied:  For use in adults and children with hemophilia A 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
 
Product Labeling:  https://www.fda.gov/media/120351/download  Opens a new window
 
PREA(P):  P
 
Sponsor:  Novo Nordisk, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antihemophilic Factor
 
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