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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:
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
PREA(P):
P
Sponsor:
Janssen Biotech, Inc.
NNPS:
FALSE
Therapeutic Category:
Anti-inflammatory
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