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

书号

1.0

研究年龄

12 YEARS - 17 YEARS

学习类型

Efficacy,Safety

研究设计

Multicenter,Randomized,Active Comparator

登记的患者

120

患者分析

N/A

中心的数量

65

国家数量

9

西班牙裔拉美裔/拉丁裔总计

N/A

非西班牙裔/非拉丁裔总人数

N/A

总数#种族不明

N/A

亚裔学生总数

N/A

黑人总数

N/A

白人总数

N/A

夏威夷或太平洋岛民总数

N/A

美洲印第安人/阿拉斯加本地人总数

N/A

其他种族总计

N/A

未知种族总数

N/A

国家

United States,Bulgaria,Georgia,Latvia,Lithuania,Poland,South Africa,Spain,Ukraine