通用名称

brivaracetam

儿科标签批准日期

2021/8/27 0:00:00

特定指示/秒

Partial-onset seizures in patients 1 month and older

标签更改摘要

- Expanded the patient population to include pediatric patients ages 1 month to 3 years for brivaracetam tablets and oral solution; previously approved down to 4 years. - Expanded the patient population to include pediatric patients ages 1 month to 15 years for brivaracetam injection. - Use in these age groups is supported by evidence from adequate and well-controlled studies in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in pediatric patients 2 months to 15 years. - Safety and effectiveness in pediatric patients below the age of 1 month have not been established. - Adverse reactions similar to those observed in adults. - Information on dosing, safety and adverse reactions, PK parameters and clinical trials. - Postmarketing study.

治疗类别

Seizures

立法类型

PREA Only

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