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Dulera Inhalation Aerosol
通用名称
formoterol fumarate/mometasone furoate
儿科标签批准日期
2019/8/12 0:00:00
特定指示/秒
Asthma in pediatric patients 5 -11 years
标签更改摘要
- Expanded indication to pediatric patients 5 to 11 years; previously approved in pediatric patients 12 years and older.
- Safety and effectiveness have not been established in children younger than 5 years.
- Safety profile for pediatric patients is similar to that observed in patients aged 12 years and older.
- New Dulera 50 mcg/5 mcg metered dose inhaler
- Information on dosing, PK parameters, adverse reactions, lab abnormalities, and clinical trial.
- Postmarketing study.
研究年龄
5 YEARS - 11 YEARS
5 YEARS - 11 YEARS
学习类型
Efficacy,Safety
Efficacy,Safety
研究设计
Multicenter,Randomized,Double-Blind,Parallel Group,Active Control
Randomized,Crossover,Single-Blind,Placebo Control,Single Dose