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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:  09/13/2017
 
Trade Name:  Aptiom
 
Generic Name or Proper Name (*):  eslicarbazepine acetate
 
Indications Studied:  Treatment of partial-onset seizures
 
Label Changes Summary:  *Safety and effectiveness have been established in the age groups 4 to 17 years. *Use in these age groups is supported by evidence from adequate and well-controlled studies in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data from clinical studies in 393 pediatric patients 4 to 17 years of age. *Safety and effectiveness in pediatric patients below the age of 4 years have not been established. *Information on dosing, adverse reactions and PK parameters. *Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Sunovion Pharmaceutical Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Anticonvulsant
 
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