Competact

RSS

pioglitazone / metformin

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 18/01/2017

Authorisation details

Product details
Name
Competact
Agency product number
EMEA/H/C/000655
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
A10BD05
Publication details
Marketing-authorisation holder
Takeda Pharma A/S
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
28/07/2006
Contact address
Dybendal Alle 10
2630 Taastrup
Denmark

Product information

12/12/2016 Competact - EMEA/H/C/000655 - A-31/1432/C/000655/0060

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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