通用名称

diclofenac epolamine

儿科标签批准日期

2019/3/1 0:00:00

特定指示/秒

Topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older

标签更改摘要

- Safety and effectiveness have been established in pediatric patients 6 years and older based on evidence from adequate and well-controlled studies in adults, as well as an open-label study in 104 pediatric patients 6 years and older. - The safety profile of Flector topical system in pediatric patients is similar to that in adults. - Safety and effectiveness have not been investigated in pediatric patients less than 6 years old. - Information on adverse reactions, PK parameters and clinical trial. - Postmarketing study.

治疗类别

N/A

立法类型

PREA Only

产品说明书链接

书号

1.0

研究年龄

6 YEARS - 16 YEARS

学习类型

Safety,Tolerability

研究设计

Open-Label

登记的患者

104

患者分析

N/A

中心的数量

10

国家数量

1

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

N/A