Relistor

RSS

methylnaltrexone bromide

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

Overview

This is a summary of the European public assessment report (EPAR) for Relistor. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Relistor.

For practical information about using Relistor, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 05/03/2019

Authorisation details

Product details
Name
Relistor
Agency product number
EMEA/H/C/000870
Active substance
methylnaltrexone bromide
International non-proprietary name (INN) or common name
methylnaltrexone bromide
Therapeutic area (MeSH)
  • Opioid-Related Disorders
  • Constipation
Anatomical therapeutic chemical (ATC) code
A06AH01
Publication details
Marketing-authorisation holder
PharmaSwiss Ceska Republika s.r.o
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
01/07/2008
Contact address
Jankovcova 1569/2c
Lighthouse
17000 Prague 7
Czech Republic

Product information

19/12/2018 Relistor - EMEA/H/C/000870 - N/0048

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

Laxatives

Therapeutic indication

Treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.

Assessment history

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