通用名称

calcipotriene/betamethasone dipropionate

儿科标签批准日期

2019/7/30 0:00:00

特定指示/秒

Plaque psoriasis of the scalp and body in patients 12 years and older

标签更改摘要

- Safety and effectiveness for the treatment of plaque psoriasis of the scalp and body have been established in pediatric patients age 12 to 17 years. - Use for this indication is supported by evidence from adequate and well-controlled trials in adults and from three uncontrolled trials in 216 adolescents. - After 4 weeks of once daily treatment, HPA axis suppression was observed in 3% of adolescents with psoriasis of the scalp and 16% of adolescents with psoriasis of the scalp and body. - Safety and effectiveness in pediatric patients less than 12 years have not been established. - Information on safety, adverse reactions, and pharmacodynamics. - 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

12 YEARS - 16 YEARS

学习类型

Efficacy,Safety

研究设计

Multicenter,Open-Label,Repeat Dose

登记的患者

106

患者分析

106

中心的数量

26

国家数量

4

西班牙裔拉美裔/拉丁裔总计

3

非西班牙裔/非拉丁裔总人数

103

总数#种族不明

0

亚裔学生总数

0

黑人总数

0

白人总数

102

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

0

其他种族总计

3

未知种族总数

N/A

国家

N/A