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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:  10/10/2019
 
Trade Name:  Wilate
 
Generic Name or Proper Name (*):  von Willebrand Factor/Coagulation Factor VIII Complex (Human)*
 
Indications Studied:  Indicated in pediatric subjects and adults with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on-demand treatment and control of bleeding episodes
 
Label Changes Summary:  See Package Insert for new information on biologics
 
PREA(P):  P
 
Sponsor:  Octapharma Pharmazeutika Prod.Ges.m.b.
 
NNPS:  FALSE
 
Therapeutic Category:  Antihemophilic Factor
 
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