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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE
 
Therapeutic Category:  Anticonvulsant
 
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