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Azstarys capsules
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.