Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Tikosyn
Auth. number : EU/1/99/121
Active substance : Dofetilide
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C01 - Cardiac therapy
Pharmacological subgroup: C01B - Antiarrhythmics, class I and III
Chemical subgroup: C01BD - Antiarrhythmics, class III
Chemical substance: C01BD04 - dofetilide
(See WHO ATC Index)
Indication: Conversion of persistent atrial fibrillation or atrial flutter to normal sinus rhythm and maintenance of sinus rhythm (after conversion).
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
02/12/1999 Centralised - Authorisation EMEA/H/C/238 (1999)3844 of 29/11/1999
16/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/238/I/5
16/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/238/I/4
16/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/238/I/1, 2, 3
04/03/2004 Centralised - Withdrawal (2004)746 of 02/03/2004