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
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02/06/2020 Multaq - EMEA/H/C/001043 - PSUSA/00001180/201907
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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