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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Novo Nordisk
NNPS:
FALSE
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