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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:
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
PREA(P):
P
Sponsor:
Novo Nordisk
NNPS:
FALSE'
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