Resolor
prucalopride
Table of contents
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.
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 |
Takeda Pharmaceuticals International AG Ireland
|
Revision |
29
|
Date of issue of marketing authorisation valid throughout the European Union |
14/10/2009
|
Contact address |
Block 2 Miesian Plaza |
Product information
14/12/2022 Resolor - EMEA/H/C/001012 - IAIN/0057
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
Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.