Cholib

RSS

fenofibrate / simvastatin

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 12/11/2020

Authorisation details

Product details
Name
Cholib
Agency product number
EMEA/H/C/002559
Active substance
  • fenofibrate
  • simvastatin
International non-proprietary name (INN) or common name
  • fenofibrate
  • simvastatin
Therapeutic area (MeSH)
Dyslipidemias
Anatomical therapeutic chemical (ATC) code
C10BA04
Publication details
Marketing-authorisation holder
Mylan IRE Healthcare Ltd
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
26/08/2013
Contact address
Unit 35/36 Grange Parade,
Baldoyle Industrial Estate,
Dublin 13
Ireland

Product information

23/10/2020 Cholib - EMEA/H/C/002559 - IAIN/0027/G

Contents

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.

Pharmacotherapeutic group

Lipid modifying agents

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.

Assessment history

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