Glubrava
pioglitazone / metformin
Table of contents
Overview
The marketing authorisation for Glubrava has been withdrawn at the request of the marketing-authorisation holder.
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List item
Glubrava : EPAR - Summary for the public (PDF/666.22 KB)
First published: 16/04/2008
Last updated: 18/10/2022 -
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List item
Glubrava : EPAR - Risk-management-plan summary (PDF/835.01 KB)
First published: 04/03/2021
Last updated: 18/10/2022
Authorisation details
| Product details | |
|---|---|
| Name |
Glubrava
|
| Agency product number |
EMEA/H/C/000893
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
|
| Anatomical therapeutic chemical (ATC) code |
A10BD05
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Takeda Pharma A/S
|
| Revision |
19
|
| Date of issue of marketing authorisation valid throughout the European Union |
11/12/2007
|
| Contact address |
Delta Park 45 |
Product information
04/02/2021 Glubrava - EMEA/H/C/000893 - WS/1979/G
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
Glubrava is indicated as second line treatment of type-2-diabetes-mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
After initiation of therapy with pioglitazone, patients should be reviewed after three to six 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.
Assessment history
News
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14/10/2016
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21/10/2011
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 201121/10/2011
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21/07/2011
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23/06/2011
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09/06/2011