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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:
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
PREA(P):
P
Sponsor:
Immunex Corporation
NNPS:
FALSE
Therapeutic Category:
Immunosuppressant
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