通用名称

onabotulinumtoxinA

儿科标签批准日期

2019/10/18 0:00:00

特定指示/秒

Treatment of lower limb spasticity in pediatric patients 2 to 17 years of age

标签更改摘要

- Safety and effectiveness have been established in pediatric patients 2 to 17 years. - Safety and effectiveness of have been established by evidence from adequate and well-controlled studies of Botox in patients 2 to 17 years with lower limb spasticity. However, treatment Botox for this indication is not intended to substitute for usual standard of care rehabilitation regimens. - A pediatric assessment for Botox demonstrated that it is safe and effective in another pediatric population. However, Botox is not approved for such patient population due to marketing exclusivity for another botulinum toxin. - Safety and effectiveness in pediatric patients below the age of 2 years have not been established. - Information on dosing, adverse reactions, and clinical trials. - Postmarketing study.

治疗类别

Spinal Cord Injury

立法类型

PREA Only

产品说明书链接