Moventig

RSS

naloxegol

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

Overview

This is a summary of the European public assessment report (EPAR) for Moventig. 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 Moventig.

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

This EPAR was last updated on 13/09/2018

Authorisation details

Product details
Name
Moventig
Agency product number
EMEA/H/C/002810
Active substance
naloxegol oxalate
International non-proprietary name (INN) or common name
naloxegol
Therapeutic area (MeSH)
  • Constipation
  • Opioid-Related Disorders
Anatomical therapeutic chemical (ATC) code
A06AH03
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Kyowa Kirin Holdings B.V.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
08/12/2014
Contact address
Bloemlaan 2
21 32NP Hoofddorp
The Netherlands

Product information

23/07/2018 Moventig - EMEA/H/C/002810 - T/0023

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

Film coated tablet

Therapeutic indication

Treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).

Assessment history

How useful was this page?

Add your rating