Pioglitazone Krka

Withdrawn

This medicine's authorisation has been withdrawn

pioglitazone

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Report (EPAR) for Pioglitazone Krka is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Pioglitazone Krka : EPAR - Summary for the public

Reference Number: EMA/684128/2011

Product information

Pioglitazone Krka : EPAR - Product Information

Pioglitazone Krka : EPAR - All Authorised presentations

Pioglitazone Krka : EPAR - Conditions imposed on member states for safe and effective use

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 diabetes

Therapeutic 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.

Authorisation details

• EMA product number:
  EMEA/H/C/002453
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Krka, d.d., Novo mesto

  Šmarješka cesta 6; 8501 Novo mesto; Slovenia

• Marketing authorisation issued:
  21/03/2012
• Withdrawal of marketing authorisation:
  16/09/2014
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Pioglitazone Krka : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Pioglitazone Krka : EPAR - Public assessment report

Reference Number: EMA/CHMP/423161/2011

CHMP summary of positive opinion for Pioglitazone Krka

AdoptedReference Number: EMA/CHMP/423166/2011