Cholestagel

RSS

colesevelam

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

Overview

This is a summary of the European public assessment report (EPAR) for Cholestagel. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Cholestagel.

This EPAR was last updated on 28/11/2018

Authorisation details

Product details
Name
Cholestagel
Agency product number
EMEA/H/C/000512
Active substance
colesevelam
International non-proprietary name (INN) or common name
colesevelam
Therapeutic area (MeSH)
Hypercholesterolemia
Anatomical therapeutic chemical (ATC) code
C10AC04
Publication details
Marketing-authorisation holder
Genzyme Europe B.V.
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
09/03/2004
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands

Product information

01/12/2017 Cholestagel - EMEA/H/C/000512 - N/0039

Contents

  • 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.

Pharmacotherapeutic group

LIPID MODIFYING AGENTS

Therapeutic indication

Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme-A (HMG-CoA)-reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density-lipoprotein-cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone.

Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated.

Cholestagel can also be used in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia (see section 5.1).

Assessment history

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