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EMA Product

Cholib

Product approved by European Medicines Agency (EU)

Basic Information

Cholib

Regulatory Information

EMEA/H/C/002559

Authorised

August 26, 2013

June 27, 2013

17

March 6, 2024

Company Information

Ireland

Damastown Industrial Park Mulhuddart Dublin 15 Dublin

VIATRIS HEALTHCARE

Active Substances Detail

fenofibratesimvastatin

Detailed Information

Therapeutic Indication

### Therapeutic indication 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.

Overview Summary

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.

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