通用名称

sacubitril/valsartan

儿科标签批准日期

2019/10/1 0:00:00

特定指示/秒

Treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older

标签更改摘要

- Safety and effectiveness in pediatric heart failure patients 1 to <18 years old are supported by the reduction from baseline to 12 weeks in NT-proBNP in a randomized, double-blind clinical study [see Clinical Studies (14.2)]. The analysis of NT-proBNP included 90 patients age 6 to 18 years and 20 patients age 1 to 6 years. - Safety and effectiveness have not been established in pediatric patients less than 1 year of age. - Adverse reactions were similar to those observed in adults. - Information on dosing, PK parameters, clinical trial, and preparation of oral solution. - New indication.

治疗类别

N/A

立法类型

PREA + BPCA

产品说明书链接