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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:
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
PREA(P):
P
Sponsor:
UCB
NNPS:
FALSE'
Therapeutic Category:
Anticonvulsant
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