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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:  10/15/2013
 
Trade Name:  Novoeight
 
Generic Name or Proper Name (*):  Antihemophilic Factor (Recombinant)
 
Indications Studied:  For adults, adolescents, and children with hemophilia A for (1) the control and prevention of bleeding episodes, (2) perioperative management, and (3) routine prophylaxis to prevent or 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:  Novo Nordisk
 
NNPS:  FALSE'
 
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