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 27/06/2023

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 Winthrop Industrie
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
25/11/2009
Contact address

82 Avenue Raspail
94250 Gentilly
FRANCE

Product information

26/06/2023 Multaq - EMEA/H/C/001043 - N/0051

Other EU languages available icon 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:

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.

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

Changes since initial authorisation of medicine

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