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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:
05/29/2009
Trade Name:
Lamictal XR
Generic Name or Proper Name (*):
lamotrigine
Indications Studied:
Adjunctive therapy for partial onset seizures in patients e13 years of age
Label Changes Summary:
Extended release tablets are indicated as adjunctive therapy for partial onset seizures with or without secondary generalization in patients e13 years Safety and effectiveness of extended release tablets for any use in patients below the age of 13 have not been established Information on adverse event profile, and clinical studies New dosage form
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
GlaxoSmithKline
NNPS:
FALSE'
Therapeutic Category:
Anticonvulsant
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