通用名称

ustekinumab

儿科标签批准日期

2020/7/29 0:00:00

特定指示/秒

Moderate to severe plaque psoriasis in pediatric patients 6 to 11 years

标签更改摘要

- Expanded indication to 6 years and older; previously approved down to 12 years. - Use in children 6 to 11 years with moderate to severe plaque psoriasis is supported by evidence from an open-label, single-arm, efficacy, safety and pharmacokinetics study in 44 patients. - Safety and effectiveness for pediatric patients less than 6 years with psoriasis have not been established. - Safety profile in pediatric patients similar to that observed in adults. - Information on adverse reactions, clinical trial, PK parameters. - 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

6 YEARS - 12 YEARS

学习类型

Efficacy,Safety

研究设计

Open-Label

登记的患者

44

患者分析

N/A

中心的数量

19

国家数量

7

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,Hungary,Netherlands,Poland