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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Multaq
|
| Auth. number : | EU/1/09/591 |
| INN : | dronedarone |
| ATC: | C - Cardiovascular system C01 - Cardiac therapy C01B - Antiarrhythmics, class I and III C01BD - Antiarrhythmics, class III C01BD07 - Dronedarone (See WHO ATC Index) |
| Indication: | MULTAQ is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF). Due to its safety profile (see sections 4.3 and 4.4), MULTAQ should only be prescribed after alternative treatment options have been considered. MULTAQ should not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure. |
| Marketing Authorisation Holder: | Sanofi
54 rue La Boétie, F-75008 Paris, France |
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 |
| 30/11/2009 | Centralised - Authorisation - Decision addressed to Member States | EMEA/H/C/1043 | (2009)9614 of 26/11/2009 | |||
| 01/12/2009 | Centralised - Authorisation | EMEA/H/C/1043 | (2009)9615 of 26/11/2009 | |||
| 27/05/2010 | Centralised - Variation | EMEA/H/C/1043/IG/4/G | ||||
| Updated with Decision(2010)7209 of 14/10/2010 | ||||||
| 04/06/2010 | Centralised - Variation | EMEA/H/C/1043/IA/1/G | ||||
| 18/10/2010 | Centralised - Variation | - | (2010)7209 of 14/10/2010 | |||
| 25/01/2011 | Centralised - Variation | EMEA/H/C/1043/II/2, 3/G | (2011)387 of 21/01/2011 | |||
| 01/02/2011 | Centralised - Variation | EMEA/H/C/1043/IB/6 | ||||
| Updated with Decision(2011)4168 of 07/06/2011 | ||||||
| 08/04/2011 | Centralised - Variation | EMEA/H/C/1043/IA/8 | ||||
| 01/06/2011 | Centralised - Variation | EMEA/H/C/1043/IB/11/G | ||||
| Updated with Decision(2011)6130 of 24/08/2011 | ||||||
| 09/06/2011 | Centralised - Variation | EMEA/H/C/1043/II/7/G | (2011)4168 of 07/06/2011 | |||
| 19/07/2011 | Centralised - Variation | EMEA/H/C/1043/II/4 | (2011)5299 of 18/07/2011 | |||
| 20/07/2011 | Centralised - Variation | EMEA/H/C/1043/II/4 | (2011)5301 of 18/07/2011 | |||
| 25/08/2011 | Centralised - Variation | EMEA/H/C/1043/II/10 | (2011)6129 of 24/08/2011 | |||
| 26/08/2011 | Centralised - Variation | EMEA/H/C/1043/II/10 | (2011)6130 of 24/08/2011 | |||
| 28/12/2011 | Referral | EMEA/H/C/1043/A-20/5 | (2011)10085 of 22/12/2011 | |||
| 29/12/2011 | Referral | EMEA/H/C/1043/A-20/5 | (2011)10084 of 22/12/2011 | |||
| 26/04/2012 | Centralised - Variation | EMEA/H/C/1043/IA/19 | ||||
| Updated with Decision(2012)6146 of 30/08/2012 | ||||||
| 03/09/2012 | Centralised - Variation | EMEA/H/C/1043/II/18 | (2012)6146 of 30/08/2012 | |||
| 26/10/2012 | Centralised - Variation | EMEA/H/C/1043/II/20 | (2012)7679 of 24/10/2012 | |||
| 14/11/2012 | Centralised - Variation | EMEA/H/C/1043/IB/22 | ||||
| 13/12/2012 | Centralised - Variation | EMEA/H/C/1043/II/21 | ||||