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Sovaldi
儿科标签批准日期
2019/8/28 0:00:00
特定指示/秒
Treatment of chronic hepatitis C virus
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, preparation and administration of oral pellets, PK parameters, adverse reactions, clinical trial.
- Two new dosage forms: oral pellets and 200 mg tablet
学习类型
Efficacy,Safety,Pharmacokinetic
研究设计
Multicenter,Open-Label,Phase 2,Single-arm