pioglitazone / glimepiride
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.
Tandemact : EPAR - Summary for the public (PDF/97.25 KB)
First published: 15/05/2008
Last updated: 14/06/2016
Tandemact : EPAR - Risk-management-plan summary (PDF/256.2 KB)
First published: 02/03/2021
|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||
07/09/2023 Tandemact - EMEA/H/C/000680 - IA/0069/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
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.
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