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
European Medicines Agency confirms recommendation to suspend Tredaptive, Pelzont and Trevaclyn
Notice type:
3rd Party Publications
Date:
18/01/2013
Product name or type:
Tredaptive, Pelzont, Trevaclyn
Active Substance:
Nicotinic acid/laropiprant
Problem Or Issue:
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has confirmed the recommendation to suspend the marketing authorisations of Tredaptive, Pelzont and Trevaclyn (nicotinic acid/laropiprant) used to treat adults with dyslipidaemia (abnormally high levels of fats such as triglycerides and cholesterol). The CHMP decision follows the recent recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend these medicines. The marketing authorisation holder, Merck Sharp and Dohme Ltd, has, in the meantime, announced that it is taking steps to suspend availability of the medicines across the European Union.
Background Information Or Related Documents:
European Medicines Agency confirms recommendation to suspend Tredaptive, Pelzont and Trevaclyn Document
Actions To Be Taken:
The CHMP encourages patients currently taking these medicines to make a non-urgent appointment with their doctor to discuss their treatment. Doctors should no loonger prescribe Tredaptive, Pelzont and Trevaclyn and should review patients' treatment options.
Further Information:
For full EMA statment please refer to link below:
European Medicines Agency confirms recommendation to suspend Tredaptive, Pelzont and Trevaclyn - press release
Please see previous publications regarding this matter:
European Medicines Agency (EMA) announces a review of Tredaptive, Pelzont and Trevaclyn
European Medicines Agency - press release
Tredaptive (nicotinic acid/laropiprant) - Letter to healthcare professionals
Irish Medicines Board communication on PRAC recommendation on Tredaptive
« Back
Date Printed: 13/05/2024