Pioglitazone Teva

Withdrawn

This medicine's authorisation has been withdrawn

pioglitazone

Overview

On 31 March 2023, the European Commission withdrew the marketing authorisation for Pioglitazone Teva (pioglitazone) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Teva B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Pioglitazone Teva was granted marketing authorisation in the EU on 26 March 2012 for the treatment of type 2 diabetes mellitus. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity on 17 February 2017. 

Pioglitazone Teva is a generic medicine of Actos, which is authorised and marketed in the EU to treat type 2 diabetes mellitus. 

The European Public Assessment Report (EPAR) for Pioglitazone Teva is updated to indicate that the marketing authorisation is no longer valid.

Pioglitazone Teva : EPAR - Summary for the public

Reference Number: EMA/222728/2012

Pioglitazone Teva : EPAR - Risk-management-plan summary

Product information

Pioglitazone Teva : EPAR - Product Information

Pioglitazone Teva : EPAR - All Authorised presentations

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

Product details

• Name of medicine:
  Pioglitazone Teva
• 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

Alimentary tract and metabolism

Therapeutic indication

Pioglitazone is indicated in the treatment of type 2 diabetes mellitus:

• 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.

Authorisation details

• EMA product number:
  EMEA/H/C/002297
• 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:
  Teva B.V.

  Swensweg 5; 2031GA Haarlem; The Netherlands

• Opinion adopted:
  19/01/2012
• Marketing authorisation issued:
  26/03/2012
• Revision:
  12

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Pioglitazone Teva : EPAR - Public assessment report

AdoptedReference Number: EMEA/CHMP/844031/2011

CHMP summary of positive opinion for Pioglitazone Teva

AdoptedReference Number: EMA/CHMP/756122/2011