通用名称

fidaxomicin

儿科标签批准日期

2020/1/24 0:00:00

特定指示/秒

Treatment of Clostridioides difficile-associated diarrhea (CDAD) in pediatric patients 6 months to 17 years

标签更改摘要

- Safety and effectiveness of the treatment of CDAD have been established in pediatric patients 6 months to 17 years. - Use of fidaxomicin in these age groups is supported by evidence from adequate and well-controlled trials of fidaxomicin in adults with CDAD and pharmacokinetic, safety and efficacy data from pediatric trials. - Adverse reactions are similar to those observed in adults. - Safety and effectiveness have not been established in pediatric patients younger than 6 months. - Information on dosing, Adverse Reactions, PK parameters and clinical trials. - New oral suspension. - Postmarketing study.

治疗类别

Anti-Infective

立法类型

BPCA Only

产品说明书链接