通用名称

pitavastatin

儿科标签批准日期

2019/5/16 0:00:00

特定指示/秒

Heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and Apo B in pediatric patients 8 years and older

标签更改摘要

- Safety and effectiveness of LIVALO as an adjunctive therapy to diet to reduce elevated TC, LDL-C, and Apo B in pediatric patients aged 8 years and older with HeFH have been established. - Use of LIVALO for this indication is supported by a 12-week, double-blind, placebo-controlled trial in 82 pediatric patients 8 to 16 years of age with HeFH and a 52-week open-label trial in 85 pediatric patients with HeFH. - Safety and effectiveness have not been established in pediatric patients younger than 8 years with HeFH or in pediatric patients with other types of hyperlipidemia (other than HeFH). - Adverse reactions in pediatric patients were similar to those observed in adults. - Information on dosing, adverse reactions, clinical trial

治疗类别

Lipid Altering Agents

立法类型

PREA Only

产品说明书链接