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