当前位置:药药网 / 数据中心 / 儿科标签更改电子表格2021
Bydureon injectable suspension
儿科标签批准日期
2021/7/22 0:00:00
特定指示/秒
Type 2 diabetes mellitus in pediatric patients 10 years and older
标签更改摘要
- Safety and effectiveness as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients aged 10 years and older.
- Use for this indication is supported by a 24-week placebo-controlled trial with 28-week open-label uncontrolled extension in 82 pediatric patients aged 10 to less than 18 years with type 2 diabetes, a pediatric pharmacokinetic study, and studies in adults with type 2 diabetes mellitus.
- Safety and effectiveness have not been established in pediatric patients less than 10 years of age.
- Information on dosing, pk parameters, and clinical studies.
- Postmarketing study.