Overview
The marketing authorisation for Glidipion has been withdrawn at the request of the marketing-authorisation holder.
Glidipion : EPAR - Summary for the public
Glidipion : EPAR - Risk-management-plan summary
Product information
Glidipion : EPAR - Product Information
Latest procedure affecting product information: WS/1791
11/06/2020
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Glidipion : EPAR - All Authorised presentations
Pioglitazone Actavis Group : EPAR - Conditions imposed on member states for safe and effective use
Product details
- Name of medicine
- Glidipion (previously Pioglitazone Actavis Group)
- Active substance
- pioglitazone hydrochloride
- International non-proprietary name (INN) or common name
- pioglitazone
- Therapeutic area (MeSH)
- Diabetes Mellitus, Type 2
- Anatomical therapeutic chemical (ATC) code
- A10BG03
Pharmacotherapeutic group
Drugs used in diabetesTherapeutic indication
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 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.
Assessment history
Glidipion : EPAR - Procedural steps taken and scientific information after authorisation