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 aged 3 months to 11 years who have been treated with a parenteral anticoagulant for at least 5 days; To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to 11 years who have been previously treated

标签更改摘要

- Safety and effectiveness of Pradaxa oral pellets for the treatment and the reduction in risk of recurrence of venous thromboembolism have been established in pediatric patients less than 12 years. Use for this indication is supported by evidence from adequate and well-controlled studies in pediatric patients. - Other age-appropriate pediatric formulations of dabigatran etexilate are available for pediatric patients aged 12 years and older 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. - Postmarketing study. - New dosage form.

治疗类别

Anti-Coagulant

立法类型

PREA + BPCA

产品说明书链接