This is a summary of the European public assessment report (EPAR) for Multaq. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Multaq.
For practical information about using Multaq, patients should read the package leaflet or contact their doctor or pharmacist.
Multaq : EPAR - Summary for the public (PDF/80.99 KB)
First published: 16/12/2009
Last updated: 01/02/2017
Multaq : EPAR - Risk-management-plan summary (PDF/65.27 KB)
First published: 03/10/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Sanofi Winthrop Industrie
|Date of issue of marketing authorisation valid throughout the European Union||
82 Avenue Raspail
26/06/2023 Multaq - EMEA/H/C/001043 - N/0051
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 201221/09/2012
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 September 201123/09/2011