通用名称

exenatide

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 17 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 trials. - Postmarketing study.

治疗类别

Type 2 Diabetes

立法类型

PREA + BPCA

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