通用名称

lacosamide

儿科标签批准日期

2021/10/14 0:00:00

特定指示/秒

Monotherapy and adjunctive therapy in the treatment of partial onset seizure patients 1 month to less than 4 years

标签更改摘要

- Safety and effectiveness for the treatment of partial-onset seizures have been established in pediatric patients 1 month to less than 4 years; previously approved down to 4 years 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 847 pediatric patients 1 month to less than 17 years of age - Safety and effectiveness in pediatric patients below 1 month of age have not been established. - Information on adverse reactions, PK parameters, and clinical trial. - Postmarketing study.

治疗类别

Seizures

立法类型

PREA Only

产品说明书链接