Tikosyn

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dofetilide

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Tikosyn has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 31/12/2009

Authorisation details

Product details
Name
Tikosyn
Agency product number
EMEA/H/C/000238
Active substance
dofetilide
International non-proprietary name (INN) or common name
dofetilide
Therapeutic area (MeSH)
  • Atrial Fibrillation
  • Atrial Flutter
Anatomical therapeutic chemical (ATC) code
C01BD04
Publication details
Marketing-authorisation holder
Pfizer Limited
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
29/11/1999
Contact address
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

31/12/2009 Tikosyn - EMEA/H/C/000238 -

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Cardiac therapy

Therapeutic 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).

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