通用名称

spinosad

儿科标签批准日期

2021/4/28 0:00:00

特定指示/秒

Topical treatment of scabies infestations in adult and pediatric patients 4 years and older

标签更改摘要

- Safety and effectiveness for the topical treatment of scabies infestation have been established in pediatric patients 4 years and older. - Use in this age group is supported by Trial 1 and Trial 2 which included 165 pediatric patients ages 4 to 17 years with scabies infestation. - Safety and effectiveness have not been established in pediatric patients less than 4 years with scabies infestation. - Information on PK parameters, adverse reactions, and clinical trials. - New indication.

治疗类别

N/A

立法类型

PREA Only

产品说明书链接