通用名称

ravulizumab-cwvz

儿科标签批准日期

2019/10/18 0:00:00

特定指示/秒

Treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).

标签更改摘要

- Safety and effectiveness for the treatment of aHUS have been established in pediatric patients aged one month and older. - Use for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic, safety, and efficacy data in pediatric patients aged 10 months to <17 years. - Safety and efficacy for the treatment of paroxysmal nocturnal hemoglobinuria in pediatric patients have not been established. - Information on dosing recommendations and considerations, adverse reactions, and clinical trial. - New indication.

治疗类别

N/A

立法类型

PREA Only

产品说明书链接

书号

1.0

研究年龄

10 MONTHS - 17 YEARS

学习类型

Efficacy,Safety,Pharmacokinetic,Pharmacodynamic

研究设计

Open-Label,Trad PK

登记的患者

16

患者分析

N/A

中心的数量

12

国家数量

6

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

N/A