通用名称

dabigatran etexilate

儿科标签批准日期

2021/6/21 0:00:00

特定指示/秒

Venous thromboembolic events (VTE) in pediatric patients 8 to 17 years; To reduce the risk of recurrence of VTE in pediatric patients 8 to 17 years who have been previously treated

标签更改摘要

- Safety and effectiveness of Pradaxa capsules for the treatment and the reduction in risk of recurrence of venous thromboembolism have been established in pediatric patients 8 to 17 years. - Use for this indication is supported by evidence from adequate and well-controlled studies in pediatric patients. - Other age-appropriate pediatric dosage forms of dabigatran etexilate are available for pediatric patients less than 8 years of age for these indications. - Safety and effectiveness have not been established in pediatric patients with non-valvular atrial fibrillation or those who have undergone hip replacement surgery. - Information on dosing, adverse reactions, PK parameters, and clinical trials. - Postmarketing study.

治疗类别

Anti-Coagulant

立法类型

PREA + BPCA

产品说明书链接