Overview

The marketing authorisation for Pioglitazone Teva has been withdrawn at the request of the marketing-authorisation holder.

Pioglitazone Teva : EPAR - Summary for the public

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Pioglitazone Teva : EPAR - Risk-management-plan summary

Product information

Pioglitazone Teva : EPAR - Product Information

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svenska (SV) (1.12 MB - PDF)

Latest procedure affecting product information: N/0025

04/11/2021

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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).

Pioglitazone Teva : EPAR - All Authorised presentations

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

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Suomi (FI) (597.87 KB - PDF)
svenska (SV) (603.53 KB - PDF)

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

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

Pioglitazone Teva : EPAR - Public assessment report

CHMP summary of positive opinion for Pioglitazone Teva

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