Tikosyn
Withdrawn
This medicine's authorisation has been withdrawn
dofetilide
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 29 November 1999, the European Commission granted a marketing authorisation for Tikosyn (dofetilide) for the whole European Union to Pfizer Ltd, UK. Tikosyn is a Class III antiarrhythmic agent indicated for the conversion of persistent atrial fibrillation or atrial flutter to normal sinus rhythm and maintenance of sinus rhythm.
Tikosyn is not marketed anywhere in the EU. On 12 January 2004, Pfizer Ltd notified the European Commission of its decision to voluntarily withdraw the Community Marketing Authorisation for Tikosyn for commercial reasons. Alternative treatments are available in Europe for this indication.
On 2 March 2004, the European Commission issued a decision to withdraw the Marketing Authorisation for Tikosyn. Consequently, the European Public Assessment Report for Tikosyn has been removed from this website.
Product information
31/12/2009
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
Product details
- Name of medicine
- Tikosyn
- 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
Pharmacotherapeutic group
Cardiac therapyTherapeutic 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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