通用名称

ruxolitinib

儿科标签批准日期

2021/9/21 0:00:00

特定指示/秒

Mild to moderate atopic dermatitis in non-immunocompromised patients 12 years and older

标签更改摘要

- Safety and effectiveness for the topical treatment of atopic dermatitis have been established in pediatric patients aged 12 to 17 years with mild-to-moderate atopic dermatitis. - Use in this age group is supported by evidence from Trials 1 and 2 which included 92 patients aged 12 to 17 years. - Safety and effectiveness in pediatric patients younger than 12 years have not been established. - Information on adverse reactions, PK parameters, and clinical trials. - New Indication and dosage form.

治疗类别

Dermatitis Agents

立法类型

PREA Only

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