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

书号

5.0 4.0 3.0 2.0 1.0

研究年龄

6 MONTHS - 18 YEARS 0 YEARS - 17 YEARS 41 DAYS - 24 WEEKS 1 YEARS - 11 YEARS 13 YEARS - 17 YEARS

学习类型

Safety,Pharmacokinetic,Pharmacodynamic Efficacy,Safety,Pharmacokinetic,Pharmacodynamic Safety,Pharmacokinetic,Pharmacodynamic,Tolerability Safety,Pharmacokinetic,Pharmacodynamic,Tolerability Safety,Pharmacokinetic,Pharmacodynamic,Tolerability

研究设计

Multicenter,Open-Label,Phase 2,Phase 3,Prospective,Single-arm Multicenter,Randomized,Active Comparator,Parallel Group,Open-Label,Phase 2,Phase 3,Non-Inferiority Multicenter,Open-Label,Single-dose,Phase 2,Non-Randomized,Single-arm Multicenter,Open-Label,Single-dose,Phase 2,Non-Randomized,Single-arm Multicenter,Open-Label,Phase 2,Non-Randomized,Single-arm

登记的患者

231 328 10 20 9

患者分析

213 267 8 18 9

中心的数量

62 65 4 8 4

国家数量

22 26 3 6 1

西班牙裔拉美裔/拉丁裔总计

9 11 0 N/A N/A

非西班牙裔/非拉丁裔总人数

203 255 7 N/A N/A

总数#种族不明

1 1 1 N/A N/A

亚裔学生总数

7 13 0 4 0

黑人总数

8 4 1 0 0

白人总数

194 245 7 14 9

夏威夷或太平洋岛民总数

0 0 0 0 0

美洲印第安人/阿拉斯加本地人总数

0 0 0 0 0

其他种族总计

3 2 0 0 0

未知种族总数

1 3 0 0 0

国家

United States,Austria,Belgium,Brazil,Canada,Czech Republic,Denmark,France,Germany,Hungary,Israel,Italy,Lithuania,Mexico,Norway,Russian Federation,Sweden,Switzerland,Taiwan,Thailand,Turkey,Ukraine United States,Argentina,Austria,Belgium,Brazil,Canada,Czech Republic,Denmark,Finland,France,Germany,Greece,Hungary,Israel,Italy,Lithuania,Mexico,Norway,Russian Federation,Spain,Sweden,Switzerland,Taiwan,Thailand,Turkey,Ukraine Canada,France,Russian Federation Canada,Italy,Lithuania,Russian Federation,Switzerland,Thailand Canada