pioglitazone / metformin

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 16/08/2023

Authorisation details

Product details
Agency product number
Active substance
  • pioglitazone
  • metformin hydrochloride
International non-proprietary name (INN) or common name
  • pioglitazone
  • metformin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
CHEPLAPHARM Arzneimittel GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Ziegelhof 24
17489 Greifswald

Product information

11/08/2023 Competact - EMEA/H/C/000655 - IA/0081/G

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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

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

Changes since initial authorisation of medicine

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