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 02/10/2019

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
Takeda Pharma A/S
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
08/01/2007
Contact address
Dybendal Alle 10
2630 Taastrup
Denmark

Product information

27/05/2019 Tandemact - EMEA/H/C/000680 - WS/1443

Contents

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

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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