Multaq

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dronedarone

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 02/02/2018

Authorisation details

Product details
Name
Multaq
Agency product number
EMEA/H/C/001043
Active substance
dronedarone
International non-proprietary name (INN) or common name
dronedarone
Therapeutic area (MeSH)
Atrial Fibrillation
Anatomical therapeutic chemical (ATC) code
C01BD07
Publication details
Marketing-authorisation holder
Sanofi-aventis groupe
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
25/11/2009
Contact address
54 rue La Boétie
75008 Paris
France

Product information

13/11/2017 Multaq - EMEA/H/C/001043 - N/0040

Contents

  • 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.

Pharmacotherapeutic group

CARDIAC THERAPY

Therapeutic 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.

Assessment history

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