Moventig
naloxegol
Table of contents
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.
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List item
Moventig : EPAR - Summary for the public (PDF/75.81 KB)
First published: 17/12/2014
Last updated: 17/12/2014 -
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List item
Moventig : EPAR - Risk-management-plan summary (PDF/64.06 KB)
First published: 17/12/2014
Last updated: 17/12/2014
Authorisation details
Product details | |
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Name |
Moventig
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Agency product number |
EMEA/H/C/002810
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Active substance |
naloxegol oxalate
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International non-proprietary name (INN) or common name |
naloxegol
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
A06AH03
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Publication details | |
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Marketing-authorisation holder |
Kyowa Kirin Holdings B.V.
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Revision |
11
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Date of issue of marketing authorisation valid throughout the European Union |
07/12/2014
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Contact address |
Product information
18/10/2019 Moventig - EMEA/H/C/002810 - IAIN/0030/G
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
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Peripheral opioid receptor antagonists
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Drugs for constipation
Therapeutic indication
Treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).