Resolor

RSS

prucalopride

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

Overview

This is a summary of the European public assessment report (EPAR) for Resolor. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Resolor.

This EPAR was last updated on 02/03/2018

Authorisation details

Product details
Name
Resolor
Agency product number
EMEA/H/C/001012
Active substance
Prucalopride succinate
International non-proprietary name (INN) or common name
prucalopride
Therapeutic area (MeSH)
Constipation
Anatomical therapeutic chemical (ATC) code
A06AX05
Publication details
Marketing-authorisation holder
Shire Pharmaceuticals Ireland Ltd
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
14/10/2009
Contact address

Block 2-3, Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 Y754 
Ireland

Product information

04/02/2018 Resolor - EMEA/H/C/001012 - IAIN/0043

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

Other drugs for constipation

Therapeutic indication

Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.

Assessment history

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