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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:
11/13/2015
Trade Name:
ADYNOVATE
Generic Name or Proper Name (*):
Antihemophilic Factor (Recombinant), PEGylated*
Indications Studied:
Adolescent and adult patients (12 years and older) with hemophilia A (congenital factor VIII deficiency) for (1) on-demand treatment and control of bleeding episodes and (2) routine prophylaxis to reduce the frequency of bleeding episodes
Label Changes Summary:
See Package Insert for new information on biologics
PREA(P):
P
Sponsor:
Baxalta US Inc.
NNPS:
FALSE
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