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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:  06/22/2017
 
Trade Name:  Simponi
 
Generic Name or Proper Name (*):  golimumab
 
Indications Studied:  Active polyarticular juvenile idiopathic arthritis
 
Label Changes Summary:  *Effectiveness in pediatric patients less than 18 years of age has not been established. *Safety and efficacy were evaluated in a multicenter, placebo-controlled, double-blind, randomized-withdrawal, parallel group study in 173 children 2 to 17 years of age with active polyarticular juvenile idiopathic arthritis (pJIA) despite treatment with MTX for at least 3 months. *Adverse reactions were similar to those observed in adults. *Information dosing, and clinical trial. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Janssen Biotech, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory
 
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