通用名称

calcipotriene

儿科标签批准日期

2019/5/6 0:00:00

特定指示/秒

Topical treatment of plaque psoriasis of the scalp and body in patients 12 years and older

标签更改摘要

- Safety and effectiveness have been established in pediatric patients age 12 years and older for topical treatment of plaque psoriasis of the scalp and body. - Use of in this age group is supported by two adequate and well controlled 8-week trials in adults and adolescents 12 years and older, with additional data from an open-label safety and pharmacokinetics study - The safety and effectiveness of in pediatric patients less than 12 years of age have not been established. - Information on adverse reactions, PK parameters, and clinical trials.

治疗类别

N/A

立法类型

PREA Only

产品说明书链接

书号

1.0

研究年龄

12 YEARS - 16 YEARS

学习类型

Safety,Pharmacokinetic,Pharmacodynamic,Tolerability

研究设计

Open-Label,Trad PK

登记的患者

19

患者分析

N/A

中心的数量

9

国家数量

1

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