pioglitazone / metformin
This is a summary of the European public assessment report (EPAR) for Competact. 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 Competact.
Competact : EPAR - Summary for the public (PDF/78.11 KB)
First published: 31/05/2007
Last updated: 02/06/2016
Competact : EPAR - Risk-management-plan summary (PDF/250.61 KB)
First published: 04/03/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Diabetes Mellitus, Type 2
|Anatomical therapeutic chemical (ATC) code||
CHEPLAPHARM Arzneimittel GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
11/08/2023 Competact - EMEA/H/C/000655 - IA/0081/G
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.
Drugs used in diabetes
Competact is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 201121/10/2011
European Medicines Agency recommends new contra-indications and warnings for pioglitazone to reduce small increased risk of bladder cancer21/07/2011
European Medicines Agency updates on ongoing benefit-risk review of pioglitazone–containing medicines23/06/2011