Tandemact
pioglitazone / glimepiride
Table of contents
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.
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List item
Tandemact : EPAR - Summary for the public (PDF/97.25 KB)
First published: 15/05/2008
Last updated: 14/06/2016 -
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List item
Tandemact : EPAR - Risk-management-plan summary (PDF/256.2 KB)
First published: 02/03/2021
Authorisation details
Product details | |
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Name |
Tandemact
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Agency product number |
EMEA/H/C/000680
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
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Anatomical therapeutic chemical (ATC) code |
A10BD06
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Publication details | |
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Marketing-authorisation holder |
CHEPLAPHARM Arzneimittel GmbH
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Revision |
22
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Date of issue of marketing authorisation valid throughout the European Union |
08/01/2007
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Contact address |
Ziegelhof 24 |
Product information
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.
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
News
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21/10/2011
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 201121/10/2011
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21/07/2011
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23/06/2011
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09/06/2011