Follow @TheHPRA
Contact us
As Gaeilge
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
Medicines
Safety Notices
My HPRA:
Login
Register
About Us
Medicines
COVID-19 vaccines and treatments
Our Role
Medicines Information
Safety Information
Safety Notices
Quality Information
Regulatory Information
News & Events
Special Topics
Emergency Medicines
Emergency Contact Details
Veterinary
Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
Multaq (dronedarone) - Restriction of use and new monitoring requirements
Notice type:
3rd Party Publications
Date:
01/11/2011
Background Information Or Related Documents:
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has completed its benefit-risk assessment of Multaq. As a result of the emergence of safety issues in the post marketing period (hepatic, lung and the negative inotropic effect), new restrictions for the use of Multaq have been introduced to maintain a positive benefit-risk balance.
Multaq (dronedarone) - Restriction of use and new monitoring requirements
« Back
Date Printed: 06/05/2024