通用名称

crisaborole

儿科标签批准日期

2020/3/23 0:00:00

特定指示/秒

Mild to moderate atopic dermatitis in patients 3 months to less than 2 years

标签更改摘要

- Safety and effectiveness have been established in pediatric patients 3 months and older for topical treatment of mild to moderate atopic dermatitis. - Use in this age group is supported by data from two 28-day, vehicle-controlled safety and efficacy trials which included 1,313 pediatric patients ages 2 years to 17 years whom received Eucrisa. - Use in pediatric patients ages 3 months to less than 2 years was supported by data from a 28-day open-label, safety and pharmacokinetics (PK) trial in 137 patients. - Safety and effectiveness in pediatric patients below the age of 3 months have not been established. - No new safety signals were identified in patients 3 months to less than 2 years. - Information on adverse reactions, PK parameters, and clinical studies. - Postmarketing study.

治疗类别

N/A

立法类型

PREA + BPCA

产品说明书链接

书号

1.0

研究年龄

3 MONTHS - 23 MONTHS

学习类型

Safety

研究设计

Multicenter,Open-Label

登记的患者

137

患者分析

137

中心的数量

32

国家数量

3

西班牙裔拉美裔/拉丁裔总计

16

非西班牙裔/非拉丁裔总人数

118

总数#种族不明

3

亚裔学生总数

27

黑人总数

11

白人总数

84

夏威夷或太平洋岛民总数

1

美洲印第安人/阿拉斯加本地人总数

1

其他种族总计

13

未知种族总数

0

国家

United States,Australia,Canada