| 商品名称 | Tikosyn |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Atrial Fibrillation;Atrial Flutter |
| 通用名/非专利名称 | dofetilide |
| 活性成分 | dofetilide |
| 产品号 | EMEA/H/C/000238 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | C01BD04 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | No |
| 是否生物类似药 | No |
| 是否附条件批准 | No |
| 是否特殊情形 | No |
| 是否加速审评 | No |
| 是否罕用药 | No |
| 上市许可日期 | 1999/11/29 |
| 上市许可开发者/申请人/持有人 | Pfizer Limited |
| 人用药物治疗学分组 | Cardiac therapy |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2009/12/31 |
| 修订号 | |
| 治疗适应症 | Tikosyn is a Class III antiarrhythmic agent that is indicated for the following: Conversion of persistent atrial fibrillation or atrial flutter to normal sinus rhythm in patients in whom cardioversion by electrical means is not appropriate and in whom the duration of the arrhythmic episode is less than 6 months (see section 5.1). Maintenance of sinus rhythm (after conversion) in patients with persistent atrial fibrillation or atrial flutter. Because TIKOSYN can cause ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic and in whom other antiarrhythmic therapy is not appropriate. Dofetilide has not been shown to be effective in patients with paroxysmal atrial arrhythmias (including paroxysmal atrial fibrillation). |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2009/12/31 |
| 最后更新日期 | 2009/12/31 |
| 产品说明书 | |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tikosyn |