通用名称

dupilumab

儿科标签批准日期

2020/5/26 0:00:00

特定指示/秒

Moderate-to-severe atopic dermatitis (AD) aged 6 to 11 years

标签更改摘要

- Safety and efficacy have been established in pediatric patients 6 years and older with moderate-to-severe atopic dermatitis; previously approved in 12 years and older. - The randomized, double-blind, placebo-controlled trial included 367 children ages 6 to 11 years old with severe atopic dermatitis. - Safety profile similar to that observed in adults with AD. - Information on dosing, adverse reactions, and clinical trial. - Postmarketing study.

治疗类别

Dermatitis Agents

立法类型

PREA Only

产品说明书链接

书号

1.0

研究年龄

6 YEARS - 11 YEARS

学习类型

Efficacy,Safety

研究设计

Placebo,Double-Blind

登记的患者

367

患者分析

N/A

中心的数量

57

国家数量

6

西班牙裔拉美裔/拉丁裔总计

N/A

非西班牙裔/非拉丁裔总人数

N/A

总数#种族不明

N/A

亚裔学生总数

N/A

黑人总数

N/A

白人总数

N/A

夏威夷或太平洋岛民总数

N/A

美洲印第安人/阿拉斯加本地人总数

N/A

其他种族总计

N/A

未知种族总数

N/A

国家

United States,Canada,Czech Republic,Germany,Poland,United Kingdom