通用名称

methylphenidate hydrochloride

儿科标签批准日期

2019/2/27 0:00:00

特定指示/秒

Attention Deficit Hyperactivity Disorder

标签更改摘要

- Safety and effectiveness have been established in one adequate and well-controlled 6-week study in pediatric patients ages 6 to 12 years, and in one adequate and well-controlled 4-week study in pediatric patients ages 12 to 17 years. - Safety and effectiveness in pediatric patients under the age of 6 years have not been established. - The long-term efficacy of methylphenidate in pediatric patients has not been established. - Information on dosing, adverse reactions, PK parameters, and clinical trials. - New dosage form

治疗类别

CNS Stimulants

立法类型

PREA Only

产品说明书链接