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Zepatier tablets
通用名称
elbasvir/grazoprevir
儿科标签批准日期
2021/12/9 0:00:00
特定指示/秒
Chronic hepatitis C infection in pediatric patients 12 years and older
标签更改摘要
- Safety, efficacy, and pharmacokinetics were evaluated in an open-label clinical trial (MK-5172-079), which included 22 subjects (n=21, genotype 1; n=1, genotype 4) 12 years of age and older who received ZEPATIER for 12 weeks.
- Safety and effectiveness have not been established in pediatric patients younger than 12 years of age who weigh less than 30 kg.
- Information on dosing, adverse reactions, PK parameters, and clinical trials.
- Postmarketing study.