Tandemact

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pioglitazone / glimepiride

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

Overview

This is a summary of the European public assessment report (EPAR) for Tandemact. 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 Tandemact.

This EPAR was last updated on 13/09/2023

Authorisation details

Product details
Name
Tandemact
Agency product number
EMEA/H/C/000680
Active substance
  • pioglitazone
  • glimepiride
International non-proprietary name (INN) or common name
  • pioglitazone
  • glimepiride
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD06
Publication details
Marketing-authorisation holder
CHEPLAPHARM Arzneimittel GmbH
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
08/01/2007
Contact address

Ziegelhof 24
17489 Greifswald
Germany

Product information

07/09/2023 Tandemact - EMEA/H/C/000680 - IA/0069/G

Other EU languages available icon 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:

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

Tandemact is indicated for the treatment of patients with type-2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.

Assessment history

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