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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:
05/18/2015
Trade Name:
Lamictal
Generic Name or Proper Name (*):
lamotrigine
Indications Studied:
Maintenance treatment of bipolar disorder
Label Changes Summary:
* Safety and efficacy for the maintenance treatment of bipolar disorder were not established in a double-blind, placebo-controlled trial that evaluated 301 pediatric patients aged 10 to 17 *Information on clinical trial and adverse reactions *Postmarketing study
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
GlaxoSmithKline
NNPS:
FALSE
Therapeutic Category:
Anticonvulsant; Mood Stablizer
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