通用名称

amphetamine

儿科标签批准日期

2021/11/4 0:00:00

特定指示/秒

Attention deficit hyperactivity disorder (ADHD) in patients 6 years and older

标签更改摘要

- Safety and effectiveness have been established in pediatric patients with ADHD ages 6 to 17 years . - Safety and effectiveness in pediatric patients younger than 6 years with ADHD have not been established. - Growth should be monitored during treatment with stimulants, including Dyanavel XR, and pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted. - Information on adverse reactions, PK parameters, and clinical trial. - New dosage form.

治疗类别

ADHD

立法类型

PREA Only

产品说明书链接