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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:
05/14/2015
Trade Name:
IXINITY
Generic Name or Proper Name (*):
Coagulation Factor IX (Recombinant)*
Indications Studied:
Indicated in adults and children equal to or greater than 12 years of age with hemophilia B for control and prevention of bleeding episodes, and for perioperative management
Label Changes Summary:
See Package Insert for new information on biologics
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Cangene Corporation
NNPS:
FALSE
Therapeutic Category:
Antihemophilic Factor
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