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Tikosyn (dofetilide)

Region

🇪🇺 EU

Active substance

dofetilide

Company

Pfizer Limited

Status

Withdrawn

Therapeutic area

Atrial Fibrillation; Atrial Flutter

EU approval

Mon 29 Nov 1999

Application

EMEA/H/C/000238

ATC

C01BD04

Official record

www.ema.europa.eu

Indication

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).

Regulatory milestones

No milestones recorded in the last year.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.