Pioglitazone Teva Pharma

Withdrawn

This medicine's authorisation has been withdrawn

pioglitazone

Overview

The marketing authorisation for Pioglitazone Teva Pharma has been withdrawn at the request of the marketing-authorisation holder.

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

Latest procedure affecting product information: IA/0024

21/06/2021

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).

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
• 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

AdoptedReference Number: EMA/CHMP/844210/2011

CHMP summary of positive opinion for Pioglitazone Teva Pharma

AdoptedReference Number: EMA/CHMP/756105/2011