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Community Register of medicinal products

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Tikosyn
Auth. number : EU/1/99/121
INN : Dofetilide
ATC: C - Cardiovascular system
C01 - Cardiac therapy
C01B - Antiarrhythmics, class I and III
C01BD - Antiarrhythmics, class III
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

The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be 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 EMEA/H/C/238/I/5
16/07/2001 Centralised - Variation EMEA/H/C/238/I/1, 2, 3
16/07/2001 Centralised - Variation EMEA/H/C/238/I/4
04/03/2004 Centralised - Withdrawal - (2004)746 of 02/03/2004