通用名称

lacosamide

儿科标签批准日期

2020/11/16 0:00:00

特定指示/秒

(1) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients with idiopathic generalized epilepsy aged 4 years and older (2) Vimpat injection is indicated for the treatment of partial-onset seizures (POS) in patients 4 years of age and older.

标签更改摘要

- Safety and effectiveness of as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in pediatric patients with idiopathic generalized epilepsy 4 years and older was established in a 24-week double-blind, randomized, placebo-controlled, parallel-group, multi-center study (Study 5), which included 37 pediatric patients 4 years to < 17 years. - Vimpat injection is indicated for the treatment of POS in pediatric patients 4 years and older. - Safety and effectiveness in pediatric patients below the age of 4 years have not been established. - Information on dosing, adverse reactions, and clinical trial. - Postmarketing requirement.

治疗类别

Seizures

立法类型

PREA Only

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