通用名称

duloxetine

儿科标签批准日期

2020/4/20 0:00:00

特定指示/秒

Fibromyalgia in pediatric patients 13 to 17 years

标签更改摘要

- Use for treatment of fibromyalgia in patients 13 to 17 years of age is supported by a 13-week placebo-controlled trial in 184 patients with juvenile fibromyalgia syndrome. - Cymbalta showed improvement over placebo on the primary endpoint, change from baseline to end-of-treatment on the Brief Pain Inventory (BPI) – Modified Short Form: Adolescent Version 24-hour average pain severity rating. - Safety and effectiveness for the treatment of fibromyalgia in patients less than 13 years of age have not been established. - Information on dosing, adverse reactions, and clinical trial. - Postmarketing study.

治疗类别

Myalgia

立法类型

PREA Only

产品说明书链接