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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:
03/16/2016
Trade Name:
KOVALTRY
Generic Name or Proper Name (*):
Antihemophilic Factor (Recombinant), Full Length*
Indications Studied:
"Indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for: • On-demand treatment and control of bleeding episodes • Perioperative management of bleeding • Routine prophylaxis to reduce the frequency of bleeding episodes"
Label Changes Summary:
See Package Insert for new information on biologics
PREA(P):
P
Sponsor:
Bayer HealthCare LLC
NNPS:
FALSE
Therapeutic Category:
Antihemophilic Factor
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