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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Baxalta US Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antihemophilic Factor
 
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