通用名称

trifarotene

儿科标签批准日期

2019/10/4 0:00:00

特定指示/秒

Acne vulgaris

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 to 17 years based on evidence from well-controlled clinical trials, a long-term safety trial, and a pharmacokinetic trial. A total of 897 pediatric subjects aged 9 to 17 years received Aklief Cream in the clinical trials - Safety and effectiveness have not been established in pediatric subjects under the age of 9 years. - Information on PK parameters and clinical trials.

治疗类别

Acne Agents

立法类型

PREA Only

产品说明书链接