The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Multaq



Sanofi Winthrop IndustrieEU/1/09/591/1-4

Main Information

Trade NameMultaq
Active SubstancesDronedarone hydrochloride
Dosage FormFilm-coated tablet
Licence HolderSanofi Winthrop Industrie
Licence NumberEU/1/09/591/1-4

Group Information

ATC CodeC01BD Antiarrhythmics, class III
C01BD07 dronedarone

Status

License statusAuthorised
Licence Issued26/11/2009
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Educational Materials - HCP

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