Pioglitazone Teva
pioglitazone
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Pioglitazone Teva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pioglitazone Teva.
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List item
Pioglitazone Teva : EPAR - Summary for the public (PDF/55.75 KB)
First published: 10/04/2012
Last updated: 10/04/2012
EMA/222728/2012 -
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Pioglitazone Teva : EPAR - Risk-management-plan summary (PDF/47.4 KB)
First published: 28/07/2020
Authorisation details
| Product details | |
|---|---|
| Name |
Pioglitazone Teva
|
| Agency product number |
EMEA/H/C/002297
|
| 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
|
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. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Teva B.V.
|
| Revision |
12
|
| Date of issue of marketing authorisation valid throughout the European Union |
26/03/2012
|
| Contact address |
Swensweg 5 |
Product information
04/11/2021 Pioglitazone Teva - EMEA/H/C/002297 - N/0025
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.