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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:  08/01/2014
 
Trade Name:  Keppra XR
 
Generic Name or Proper Name (*):  levetiracetam
 
Indications Studied:  Adjunctive therapy in the treatment of partial onset seizures
 
Label Changes Summary:  Safety and effectiveness in pediatric patients 12 years and older have been established based on PK data in adults and adolescents using Keppra XR and efficacy and safety data in pediatric studies using immediate-release Keppra Safety and effectiveness of in patients below the age of 12 years have not been established Information on PK parameters and PK study Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  UCB
 
NNPS:  FALSE'
 
Therapeutic Category:  Anticonvulsant
 
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