通用名称

deutetrabenazine

儿科标签批准日期

2021/6/24 0:00:00

特定指示/秒

Tourette Syndrome

标签更改摘要

- Safety and effectiveness have not been established in pediatric patients for the treatment of Tourette syndrome. - Efficacy was not demonstrated in two randomized, double-blind, placebo-controlled studies in pediatric patients aged 6 to 16 years with Tourette syndrome. - One study evaluated fixed doses of deutetrabenazine over 8 weeks; the other evaluated flexible doses of deutetrabenazine over 12 weeks. The studies included a total of 274 pediatric patients who received at least one dose of deutetrabenazine or placebo. - Information on adverse reactions, and clinical trials.

治疗类别

Other Movement Disorders

立法类型

BPCA Only

产品说明书链接