通用名称

serdexmethylphenidate/dexmethylphenidate

儿科标签批准日期

2021/3/2 0:00:00

特定指示/秒

Attention Deficit Hyperactivity Disorder in pediatric patients 6 to 17 years

标签更改摘要

- Safety and effectiveness have been established in pediatric patients ages 6 to 17 years for the treatment of ADHD. - Use in patients 6 to 12 years is supported by a randomized, double-blind, placebo-controlled, parallel group trial in 155 pediatric patients with ADHD and a 12-month open-label long term safety trial in 238 patients. - Use in pediatric patients 13 to 17 years is supported by additional pharmacokinetics analysis showing similar plasma concentration-time profiles of dexmethylphenidate in adolescents and adults after administration of the same dose of AZSTARYS. - The long-term efficacy of methylphenidate in pediatric patients has not been established. - Safety and effectiveness in pediatric patients less than 6 years have not been established. - Information on dosing, adverse reactions, PK parameters, and clinical trials. - New active ingredient and new combination.

治疗类别

ADHD

立法类型

PREA Only

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