Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Multaq   
Auth. number : EU/1/09/591
INN : dronedarone
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: 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, 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-Aventis groupe
54 rue La Boétie, F-75008 Paris, France

  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 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
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, EMEA/H/C/1043/II/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
Updated with Decision(2013)6352 of 25/09/2013
13/12/2012 Centralised - Variation EMEA/H/C/1043/II/21
Updated with Decision(2013)6352 of 25/09/2013
23/08/2013 Centralised - Variation EMEA/H/C/1043/N/26
Updated with Decision(2013)8152 of 15/11/2013
27/09/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1043/T/25 (2013)6352 of 25/09/2013
19/11/2013 Centralised - Modification EMEA/H/C/1043/PSUV/27 (2013)8152 of 15/11/2013