Pioglitazone Teva Pharma
pioglitazone
Table of contents
Overview
The marketing authorisation for Pioglitazone Teva Pharma has been withdrawn at the request of the marketing-authorisation holder.
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Pioglitazone Teva Pharma : EPAR - Summary for the public (PDF/632.55 KB)
First published: 11/04/2012
Last updated: 30/08/2022
EMA/239161/2012 -
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Pioglitazone Teva Pharma : EPAR - Risk-management-plan summary (PDF/624.74 KB)
First published: 21/07/2020
Last updated: 30/08/2022
Authorisation details
| Product details | |
|---|---|
| Name |
Pioglitazone Teva Pharma
|
| Agency product number |
EMEA/H/C/002410
|
| 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 Pharma B.V.
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| Revision |
13
|
| Date of issue of marketing authorisation valid throughout the European Union |
26/03/2012
|
| Contact address |
Computerweg 10
NL-3542 DR Utrecht The Netherlands |
Product information
21/06/2021 Pioglitazone Teva Pharma - EMEA/H/C/002410 - IA/0024
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
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.