通用名称

dupilumab

儿科标签批准日期

2019/3/11 0:00:00

特定指示/秒

Moderate-to-severe atopic dermatitis

标签更改摘要

- Safety and efficacy have been established in pediatric patients 12 years and older. - A total of 251 adolescents ages 12 to 17 years old with moderate-to-severe atopic dermatitis were enrolled in the clinical trial. - Safety and efficacy in pediatric patients less than12 years with atopic dermatitis have not been established. - The safety profile in pediatric patients is similar to that in adults. - Information on adverse reactions, PK parameters and clinical trial. - Postmarketing study.

治疗类别

N/A

立法类型

PREA Only

产品说明书链接