通用名称

tedizolid phosphate

儿科标签批准日期

2020/6/19 0:00:00

特定指示/秒

Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults to include pediatric patients from 12 years to less than 18 years

标签更改摘要

- Expanded indication for the treatment ABSSSI to include pediatric patients from 12 years and older. - Use is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 12 years and older - Safety and effectiveness in pediatric patients below the age of 12 years have not been established. - Information on dosing, adverse reactions, PK parameters, and clinical trial. - Postmarketing study.

治疗类别

Antibacterials

立法类型

PREA Only

产品说明书链接