methylnaltrexone bromide

This medicine is authorised for use in the European Union.


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 31/10/2022

Authorisation details

Product details
Agency product number
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
Publication details
Marketing-authorisation holder
Bausch Health Ireland Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

3013 Lake Drive
Citywest Business Campus
Dublin 24
D24PPT3 Ireland

Product information

28/10/2022 Relistor - EMEA/H/C/000870 - IAIN/0058

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Peripheral opioid receptor antagonists

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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