- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 16 September 2014, the European Commission withdrew the marketing authorisation for Pioglitazone Krka (pioglitazone) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Krka d.d. Novo mesto, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Pioglitazone Krka was granted marketing authorisation in the EU on 21 March 2012 for treatment of type 2 diabetes mellitus. The marketing authorisation was initially valid for a 5-year period. Pioglitazone Krka 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Report (EPAR) for Pioglitazone Krka is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
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).
Product details
- Name of medicine
- Pioglitazone Krka
- 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
- 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;
Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus in 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.