通用名称

solifenacin succinate

儿科标签批准日期

2020/5/26 0:00:00

特定指示/秒

Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older

标签更改摘要

- Safety and effectiveness have been established in pediatric patients aged 2 years and older for the treatment of NDO and the information on this use is discussed throughout the labeling. - Safety and effectiveness have not been established in pediatric patients less than 2 years of age. - Information on dosing, adverse reactions, and clinical trials. - Postmarketing study. - New dosage form.

治疗类别

Neurogenic detrusor overactivity

立法类型

PREA + BPCA

产品说明书链接

书号

3.0 2.0 1.0

研究年龄

6 MONTHS - 4 YEARS 5 YEARS - 17 YEARS 5 YEARS - 17 YEARS

学习类型

Efficacy,Safety,Pharmacokinetic Efficacy,Safety,Pharmacokinetic Safety,Pharmacokinetic,Tolerability

研究设计

Multicenter,Open-Label,Phase 3,Long-term Multicenter,Open-Label,Phase 3,Long-term Multicenter,Open-Label,Single-dose

登记的患者

23 76 14

患者分析

19 76 14

中心的数量

8 21 4

国家数量

6 10 4

西班牙裔拉美裔/拉丁裔总计

1 11 N/A

非西班牙裔/非拉丁裔总人数

18 65 N/A

总数#种族不明

0 0 N/A

亚裔学生总数

9 23 0

黑人总数

0 2 0

白人总数

10 45 14

夏威夷或太平洋岛民总数

0 0 0

美洲印第安人/阿拉斯加本地人总数

0 0 0

其他种族总计

0 6 0

未知种族总数

0 0 0

国家

United States,Belgium,Korea, Republic of,Philippines,Poland,United Kingdom United States,Belgium,Brazil,Denmark,Hungary,Korea, Republic of,Mexico,Philippines,Poland,Turkey Belgium,Denmark,Poland,United Kingdom