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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:
11/03/2017
Trade Name:
Vimpat
Generic Name or Proper Name (*):
lacosamide
Indications Studied:
Treatment of partial-onset seizures to patients 4 years of age and older
Label Changes Summary:
*Expanded the use of Vimpat tablets and oral solution for the treatment of partial-onset seizures to patients 4 years of age and older. *Use in this age group 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 in 328 pediatric patients 4 to less than 17 years of age. *Safety and effectiveness in pediatric patients below the age of 4 years have not been established. *Safety of Vimpat injection in pediatric patients has not been established. *In pediatric patients 4 years to less than 17 years of age, the recommended dosing regimen is based on body weight and is only recommended to be administered orally. *Adverse reactions were similar to those observed in adults. *Information on PK parameters, dosing, adverse reactions. *Postmarketing study.
PREA(P):
P
Sponsor:
UCB, Inc.
NNPS:
TRUE
Therapeutic Category:
Anticonvulsant
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