当前位置:药药网 / 数据中心 / 儿科研究特征电子表格
Livalo
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