通用名称

vortioxetine

儿科标签批准日期

2021/1/22 0:00:00

特定指示/秒

Major Depressive Disorder

标签更改摘要

- Safety and effectiveness have not been established in pediatric patients for the treatment of MDD. - Efficacy was not established in an 8-week, randomized, double-blind, placebo-controlled, active-reference study in 615 pediatric patients 12 to 17 years of age with MDD. - The primary efficacy endpoint was change from double-blind baseline to Week 8 on the Children’s Depression Rating Scale-Revised version. The effect of treatment with vortioxetine was not significantly different from placebo. - In this age group, adverse reactions were generally similar to those reported in adults. - Antidepressants, such as vortioxetine, increase the risk of suicidal thoughts and behaviors in pediatric patients. - Information about false positive result in urine immunoassays for methadone was added to labeling. - The terms "headache," "hyperhidrosis," and "hyperprolactinemia" were added to the Adverse Reactions Postmarketing Experience section. - Information on adverse reactions, and clinical trial.

治疗类别

Antidepressants

立法类型

PREA + BPCA

产品说明书链接