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 06/01/2022

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 Branch
Revision
27
Date of issue of marketing authorisation valid throughout the European Union
14/10/2009
Contact address

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

Product information

21/12/2021 Resolor - EMEA/H/C/001012 - IA/0054/G

Product information documents contain:

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

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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