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