Relistor
methylnaltrexone bromide
Table of contents
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.
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) |
|
Anatomical therapeutic chemical (ATC) code |
A06AH01
|
Publication details | |
---|---|
Marketing-authorisation holder |
Bausch Health Ireland Limited
|
Revision |
18
|
Date of issue of marketing authorisation valid throughout the European Union |
01/07/2008
|
Contact address |
3013 Lake Drive |
Product information
28/10/2022 Relistor - EMEA/H/C/000870 - IAIN/0058
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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.