当前位置：药药网 / 数据中心 / 儿科标签更改电子表格2021
Qelbree extended-release capsules
儿科标签批准日期
2021/4/2 0:00:00
特定指示/秒
Attention deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years
标签更改摘要
- Safety and effectiveness in pediatric patients 6 to 17 years with ADHD have been established based on randomized, placebo-controlled studies in pediatric patients.
- Patients treated with Qelbree should be monitored for suicidal thoughts and behavior and for changes in weight.
- Safety and effectiveness have not been established in pediatric patients younger than 6 years old.
- Information on dosing, PK parameters, adverse reactions, and clinical trial.
- New drug.