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Harvoni
通用名称
ledipasvir/sofosbuvir
儿科标签批准日期
2019/8/28 0:00:00
特定指示/秒
Treatment of pediatric patients 3 to less than 12 years, weighing at least 17 kg, with chronic hepatitis C virus (HCV)
标签更改摘要
- Expanded indication to pediatric patients 3 to 11 years; previously approved in pediatric patients 12 years and older.
- Safety and efficacy have not been established in pediatric patients less than 3 years of age.
- Adverse reactions were similar to those observed in adults.
- Information on dosing, PK parameters, adverse reactions, clinical trial.
- New dosage form.
学习类型
Efficacy,Safety,Pharmacokinetic
研究设计
Multicenter,Open-Label,Phase 2
国家
United States,Australia,New Zealand,United Kingdom