Pioglitazone Teva Pharma

Withdrawn

This medicine's authorisation has been withdrawn

pioglitazone

Overview

On 22 June 2021, the European Commission withdrew the marketing authorisation for Pioglitazone Teva Pharma (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 Pharma was granted marketing authorisation in the EU on 26 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 2017. The product had not been marketed in the EU since 2021. 

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Assessment Report (EPAR) for Pioglitazone Teva Pharma is updated to indicate that the marketing authorisation is no longer valid.

Pioglitazone Teva Pharma : EPAR - Summary for the public

Reference Number: EMA/239161/2012

Pioglitazone Teva Pharma : EPAR - Risk-management-plan summary

Product information

Pioglitazone Teva Pharma : EPAR - Product Information

Pioglitazone Teva Pharma : EPAR - All Authorised presentations

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

Product details

• Name of medicine:
  Pioglitazone Teva Pharma
• 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 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.

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/002410
• 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 Pharma B.V.

  Computerweg 10; NL-3542 DR Utrecht; The Netherlands

• Opinion adopted:
  19/01/2012
• Marketing authorisation issued:
  26/03/2012
• Withdrawal of marketing authorisation:
  22/06/2021
• Revision:
  13

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Pioglitazone Teva Pharma : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/844210/2011

CHMP summary of positive opinion for Pioglitazone Teva Pharma

Adopted Reference Number: EMA/CHMP/756105/2011