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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:
12/22/2016
Trade Name:
ADYNOVATE
Generic Name or Proper Name (*):
Antihemophilic Factor (Recombinant), PEGylated*
Indications Studied:
Treatment and control of bleeding episodes in adolescents and adults with hemophilia A. Routine prophylaxis to reduce the frequency of bleeding episodes in adolescents and adults with hemophilia A.
Label Changes Summary:
See Package Insert for new information on biologics
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Baxalta US Inc.
NNPS:
FALSE
Therapeutic Category:
Antihemophilic Factor
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