pioglitazone / metformin

This medicine is authorised for use in the European Union.


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 12/08/2019

Authorisation details

Product details
Agency product number
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
Publication details
Marketing-authorisation holder
Takeda Pharma A/S
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Delta Park 45
2665 Vallensbaek Strand

Product information

06/06/2019 Glubrava - EMEA/H/C/000893 - PSUSA/00002417/201807


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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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