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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:
09/22/2006
Trade Name:
Lamictal Tablets Lamictal Chewable Dispersible Tablets
Generic Name or Proper Name (*):
lamotrigine
Indications Studied:
Adjunctive therapy for primary generalized tonic-clonic seizures in children 2 years of age and older
Label Changes Summary:
Effectiveness established in study with patients down to 2 years of age Revised boxed warning to remove restrictions on use in pediatric patients New indication
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
GlaxoSmithKline
NNPS:
FALSE'
Therapeutic Category:
Anticonvulsant
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