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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:  12/22/2009
 
Trade Name:  Topamax
 
Generic Name or Proper Name (*):  topiramate
 
Indications Studied:  Migraine Prophylaxis
 
Label Changes Summary:  * Safety and effectiveness for migraine prevention in pediatric patients have not been established * Dose-related increased shift in serum creatinine in adolescent patients occurred in a clinical study * Information added to Warnings and Precautions and Pediatric Use
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Ortho-McNeil-Janssen
 
NNPS:  FALSE
 
Therapeutic Category:  Anticonvulsant
 
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