通用名称

mesalamine

儿科标签批准日期

2020/6/26 0:00:00

特定指示/秒

Mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg

标签更改摘要

- Safety and effectiveness have been established for the treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. - Use in this population is supported by evidence from adequate and well-controlled trials in adults, a multicenter, randomized, double-blind, parallel group trial in 105 pediatric patients 5 to 17 years of age, and additional pharmacokinetic analyses. - Safety profile in pediatric patients was similar to that observed in adults. - Safety and effectiveness have not been established in patients weighing less than 24 kg. - Information on dosing, adverse reactions and clinical trial. - New indication.

治疗类别

Ulcerative Colitis

立法类型

PREA Only

产品说明书链接

书号

2.0 1.0

研究年龄

5 YEARS - 17 YEARS 5 YEARS - 17 YEARS

学习类型

Safety,Pharmacokinetic,Tolerability Efficacy,Safety

研究设计

Multicenter,Randomized,Open-Label Multicenter,Randomized,Double-Blind,Parallel Group

登记的患者

52 107

患者分析

N/A N/A

中心的数量

12 33

国家数量

3 6

西班牙裔拉美裔/拉丁裔总计

N/A N/A

非西班牙裔/非拉丁裔总人数

N/A N/A

总数#种族不明

N/A N/A

亚裔学生总数

N/A N/A

黑人总数

N/A N/A

白人总数

N/A N/A

夏威夷或太平洋岛民总数

N/A N/A

美洲印第安人/阿拉斯加本地人总数

N/A N/A

其他种族总计

N/A N/A

未知种族总数

N/A N/A

国家

United States,Poland,Slovakia United States,Hungary,Israel,Poland,Slovakia,United Kingdom