Competact
pioglitazone / metformin
Table of contents
Overview
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.
-
List item
Competact : EPAR - Summary for the public (PDF/78.11 KB)
First published: 31/05/2007
Last updated: 02/06/2016 -
-
List item
Competact : EPAR - Risk-management-plan summary (PDF/250.61 KB)
First published: 04/03/2021
Authorisation details
Product details | |
---|---|
Name |
Competact
|
Agency product number |
EMEA/H/C/000655
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
|
Anatomical therapeutic chemical (ATC) code |
A10BD05
|
Publication details | |
---|---|
Marketing-authorisation holder |
CHEPLAPHARM Arzneimittel GmbH
|
Revision |
21
|
Date of issue of marketing authorisation valid throughout the European Union |
28/07/2006
|
Contact address |
Ziegelhof 24 |
Product information
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.
Pharmacotherapeutic group
Drugs used in diabetes
Therapeutic indication
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.
Assessment history
News
-
14/10/2016
-
21/10/2011
-
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 201121/10/2011
-
21/07/2011
-
23/06/2011
-
09/06/2011