通用名称

pregabalin

儿科标签批准日期

2019/5/23 0:00:00

特定指示/秒

Treatment of partial-onset seizures (POS), to include pediatric patients 1 month to less than 4 years

标签更改摘要

- Safety and effectiveness as adjunctive treatment for POS in pediatric patients 1 month to less than 4 years have been established in a 14-day double-blind, placebo-controlled study (N=175). Previously approved in 4 years and older. - The youngest subject evaluated was 3 months of age; use in patients 1 month to less than 3 months of age is supported by additional pharmacokinetic analyses. - Safety and effectiveness in pediatric patients below the age of 1 month have not been established. - The most common dose-related adverse reactions (>5%) with Lyrica in this study were somnolence, pneumonia, and viral infection. - Information on dosing, adverse reactions, PK parameters, and clinical trial. - Postmarketing study

治疗类别

Seizures

立法类型

PREA + BPCA

产品说明书链接