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Eucrisa ointment
儿科标签批准日期
2020/3/23 0:00:00
特定指示/秒
Mild to moderate atopic dermatitis in patients 3 months to less than 2 years
标签更改摘要
- Safety and effectiveness have been established in pediatric patients 3 months and older for topical treatment of mild to moderate atopic dermatitis.
- Use in this age group is supported by data from two 28-day, vehicle-controlled safety and efficacy trials which included 1,313 pediatric patients ages 2 years to 17 years whom received Eucrisa.
- Use in pediatric patients ages 3 months to less than 2 years was supported by data from a 28-day open-label, safety and pharmacokinetics (PK) trial in 137 patients.
- Safety and effectiveness in pediatric patients below the age of 3 months have not been established.
- No new safety signals were identified in patients 3 months to less than 2 years.
- Information on adverse reactions, PK parameters, and clinical studies.
- Postmarketing study.