通用名称

incobotulinumtoxinA

儿科标签批准日期

2020/12/18 0:00:00

特定指示/秒

Treatment of chronic sialorrhea in patients 2 years and older

标签更改摘要

- Safety and effectiveness have been established by evidence from an adequate and well-controlled study in patients 6 to 17 years with chronic sialorrhea. - Use in patients 2 to 5 years of age is supported by the findings of efficacy and safety in patients 6 years and older with chronic sialorrhea, and by safety data in patients 2 to 5 years. - Safety and effectiveness in pediatric patients below the age of 2 years have not been established. - Postmarketing study.

治疗类别

N/A

立法类型

PREA Only

产品说明书链接