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Asmanex HFA
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 Asmanex HFA 50 mcg/5 mcg metered dose inhaler
- Information on dosing, adverse reactions, clinical trial.
- Postmarketing study.