Glustin : EPAR - Summary for the public (PDF/678.57 KB)
First published: 16/09/2008
Last updated: 17/10/2022
Glustin : EPAR - Risk-management-plan summary (PDF/837.84 KB)
First published: 02/03/2021
Last updated: 17/10/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Diabetes Mellitus, Type 2
|Anatomical therapeutic chemical (ATC) code||
Takeda Pharma A/S
|Date of issue of marketing authorisation valid throughout the European Union||
Delta Park 45
04/02/2021 Glustin - EMEA/H/C/000286 - WS/1979/G
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Drugs used in diabetes
Pioglitazone is indicated as second or third line treatment of type-2 diabetes mellitus as described below:
- as monotherapy:
- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.
- as dual oral therapy in combination with:
- metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;
- a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;
- as triple oral therapy in combination with:
- metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.
Pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 201121/10/2011
European Medicines Agency recommends new contra-indications and warnings for pioglitazone to reduce small increased risk of bladder cancer21/07/2011
European Medicines Agency updates on ongoing benefit-risk review of pioglitazone–containing medicines23/06/2011