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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:  11/04/2016
 
Trade Name:  Enbrel
 
Generic Name or Proper Name (*):  etanercept
 
Indications Studied:  Chronic moderate to severe plaque psoriasis (PsO ) in patient who are candidates for systemic therapy or phototherapy patients ages 4 to 17 years
 
Label Changes Summary:  *Expanded the indication from adults to pediatric patients 4 to 17 years. *Enbrel has been studied in 211 pediatric patients with moderate to severe PsO aged 4 to 17 years. * Enbrel has not been studied in children less than 4 years of age with PsO. * Adverse events were similar to those observed in adults. *Information on dosing, PK, adverse reactions, and clinical trial. * New indication.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Immunex Corporation
 
NNPS:  FALSE
 
Therapeutic Category:  Immunosuppressant
 
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