fenofibrate / simvastatin
This is a summary of the European public assessment report (EPAR) for Cholib. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Cholib.
For practical information about using Cholib, patients should read the package leaflet or contact their doctor or pharmacist.
Cholib : EPAR - Summary for the public (PDF/81.54 KB)
First published: 18/09/2013
Last updated: 18/09/2013
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Mylan IRE Healthcare Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
Unit 35/36 Grange Parade,
Baldoyle Industrial Estate,
03/06/2021 Cholib - EMEA/H/C/002559 - II/0029/G
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Lipid modifying agents
Cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL C levels when LDL C levels are adequately controlled with the corresponding dose of simvastatin monotherapy.