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||
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Mylan IRE Healthcare Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
23/10/2020 Cholib - EMEA/H/C/002559 - IAIN/0027/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.