US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| MULTAQ | EQ 400MG BASE | tablet · oral | SANOFI AVENTIS US | Prescription | 1 Jul 2009 |
| DRONEDARONE HYDROCHLORIDE | EQ 400MG BASE | tablet · oral | LUPIN | Discontinued | 31 Jan 2024 |
EMA European Union — centrally authorised medicines
Multaq Sanofi Winthrop Industrie · Authorised · authorised 25 Nov 2009 · ATC C01BD07
Therapeutic indication (EMA)
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.
Multaq Sanofi-Aventis · Application withdrawn
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| MULTAQ | 02330989 | 400 MG | TABLET · ORAL | SANOFI-AVENTIS CANADA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | MULTAQ 400 MG TABLET | $13.18651 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Dronedarone 400mg tablets | £14.62 | 20 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 23 Oct 2023 MULTAQ — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - MHRA 11 Dec 2014 Dronedarone (Multaq▼): cardiovascular, hepatic and pulmonary adverse events – new restrictions and monitoring requirements
Following new evidence of cardiovascular, hepatic and pulmonary risk, a review of dronedarone has concluded that the benefits of treatment continue to outweigh the risks for the maintenance of sinus rhythm after successful cardioversion in a limited population of patients with paroxysmal or persistent atrial fibrillation; however, in light of safety concerns dronedarone should only be prescribed after other treatment options have been considered. To support safer use, patients should have their treatment reviewed at the next routine appointment to ensure that they remain eligible for dronedarone treatment according to the revised prescribing information, including new restrictions on use. Regular monitoring of cardiac, liver, and renal function during treatment is recommended
All safety entries for dronedarone →
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.