法规知识库 · EMA 集中审评
Tikosyn
dofetilide · EMEA/H/C/000238 · 已撤市
获批上市许可
1999-11-29
欧委会决定日
2009-12-31
持有人 / 申请人
Pfizer Limited
终止日期字段
2004-03-02
从产品到官方文件
文件记录
0
官方索引 0
EPAR / 审评
0
assessment / overview 等
产品信息
0
PI / presentations
其他
0
RMP / PIP 等
ATC:C01BD04
治疗领域:Atrial Fibrillation;Atrial Flutter
药理分类:Cardiac therapy
修订号:— · 最新影响 PI 的程序:—
适应症(原文):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).
关键日期时间轴
来自 EMA medicines JSON 日期字段;缺失字段不展示,不补推结论。
2009-12-31 · 欧委会决定
2004-03-02 · 上市许可终止(撤市/失效/撤销等)
Withdrawn
1999-11-29 · 获批上市许可
说明书、EPAR 与其他文件
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数据来自 EMA 官方 JSON;最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。