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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:  10/10/2008
 
Trade Name:  Kogenate FS
 
Generic Name or Proper Name (*):  Antihemophilic Factor (Recombinant)*
 
Indications Studied:  Routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage
 
Label Changes Summary:  See Package Insert for new information on biologics
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bayer
 
NNPS:  FALSE
 
Therapeutic Category:  Hematology/Coagulation
 
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