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Dyanavel XR extended-release tablets
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.