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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:
07/15/2011
Trade Name:
Topamax
Generic Name or Proper Name (*):
topiramate
Indications Studied:
Monotherapy for partial onset or primary generalized tonic-clonic seizures
Label Changes Summary:
Expanded age range down to 2 years; previously approved for monotherapy for partial onset or primary generalized tonic-clonic seizures in patients10 years and older Information on weight based dosing in 2 to < 10 yearsPostmarketing study
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Janssen
NNPS:
FALSE'
Therapeutic Category:
Anticonvulsant
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