Glubrava

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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 Glubrava. 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 Glubrava.

This EPAR was last updated on 21/11/2017

Authorisation details

Product details
Name
Glubrava
Agency product number
EMEA/H/C/000893
Active substance
  • metformin hydrochloride
  • pioglitazone 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
15
Date of issue of marketing authorisation valid throughout the European Union
10/12/2007
Contact address
Dybendal Alle 10
2630 Taastrup
Denmark

Product information

09/11/2017 Glubrava - EMEA/H/C/000893 - R/0054

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

Glubrava is indicated as second line treatment of type-2-diabetes-mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.

After initiation of therapy with pioglitazone, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.

Assessment history

Changes since initial authorisation of medicine

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