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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WITHDRAWN |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 procedures
| 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 |