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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:  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 years* Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Janssen
 
NNPS:  FALSE
 
Therapeutic Category:  Anticonvulsant
 
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