Basic Information
Pioglitazone Accord
Regulatory Information
EMEA/H/C/002277
March 21, 2012
January 19, 2012
9
August 27, 2024
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Pioglitazone is indicated in the treatment of type-2 diabetes mellitus: **as monotherapy** - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 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.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Pioglitazone Accord. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Pioglitazone Accord. For practical information about using Pioglitazone Accord, patients should read the package leaflet or contact their doctor or pharmacist.