Xeljanz oral solution
通用名称
tofacitinib
儿科标签批准日期
2020/9/25 0:00:00
特定指示/秒
Active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years and older
标签更改摘要
- Safety and effectiveness for the treatment of active pcJIA have been established in patients 2 to 17 years. - Use for the treatment of pediatric patients with active pcJIA in this age group is supported by evidence from adequate and well-controlled studies of Xeljanz in adult RA patients with additional data from a clinical trial in pediatric patients with active pcJIA consisting of an 18-week, open label, run-in period followed by a 26-week placebo-controlled, randomized withdrawal period - Safety and effectiveness have not been established in pcJIA patients less than 2 years of age. - Adverse reactions observed in pediatric patients were consistent with those reported in RA patients. - Safety and efficacy in pediatric patients for indications other than pcJIA have not been established. - Safety and effectiveness of XELJANZ XR in pediatric patients have not been established. - Information on adverse reactions and clinical trial.
治疗类别
Systemic Juvenile Idiopathic Arthritis
立法类型
PREA Only
产品说明书链接
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