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Arazlo
儿科标签批准日期
2019/12/18 0:00:00
特定指示/秒
Acne vulgaris in patients 9 years and older
标签更改摘要
- Safety and effectiveness for the topical treatment of acne vulgaris have been established in pediatric patients age 9 years and older based on evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled, 12-week clinical trials and an open-label pharmacokinetic study.
- A total of 300 pediatric subjects aged 9 to less than 17 years received Arazlo in the clinical studies.
- Safety and effectiveness in pediatric patients below the age of 9 years have not been established.
- New dosage form.