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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:  05/31/2017
 
Trade Name:  Rebinyn
 
Generic Name or Proper Name (*):  Coagulation Factor IX (Recombinant), GlycoPEGylated*
 
Indications Studied:  Approved for use in adults and children with hemophilia B for: (1) On-demand treatment and control of bleeding episodes; (2) 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:  Novo Nordisk
 
NNPS:  FALSE
 
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