Glidipion (previously Pioglitazone Actavis Group)
Withdrawn
This medicine's authorisation has been withdrawn
pioglitazone
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 19 July 2021, the European Commission withdrew the marketing authorisation for Glidipion (pioglitazone) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Actavis Group PTC ehf, which notified the European Commission of its decision not to market the product in the EU for commercial reasons.
Glidipion was granted marketing authorisation in the EU on 15 March 2012 for treatment of type 2 diabetes mellitus. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2016. The product has not been marketed in the EU.
Glidipion is a generic medicine of Actos. There are other generic medicinal products of Actos authorised and marketed in the EU.
The European Public Assessment Report (EPAR) for Glidipion is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
WS/1791
11/06/2020
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
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.
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