通用名称

calcitriol

儿科标签批准日期

2020/7/17 0:00:00

特定指示/秒

Mild to moderate plaque psoriasis in pediatric patients 2 years and older

标签更改摘要

- Safety and effectiveness have been established in pediatric patients 2 years and older for topical treatment of mild to moderate psoriasis. - Use in this age group is supported by two adequate and well-controlled 8-week trials and an open label trial in adult subjects, and additional data from trials conducted in pediatric subjects 2 to 17 years. - Data from 63 patients 2 to 12 years, and 42 patients 13 to 17 years showed no significant effects on indices of calcium metabolism. - No new safety signals were identified in patients 2 to 17 years. -Safety and effectiveness not established in patients younger than 2 years. - Information on dose, adverse reactions, PK parameters, and clinical trial. - Postmarketing study.

治疗类别

Psoriasis Agents

立法类型

PREA Only

产品说明书链接

书号

1.0

研究年龄

2 YEARS - 16 YEARS

学习类型

Efficacy,Safety,Pharmacokinetic,Pharmacodynamic

研究设计

Multicenter,Open-Label

登记的患者

54

患者分析

N/A

中心的数量

30

国家数量

5

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,Belgium,Canada,Germany,Italy