Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Jentadueto   
Auth. number : EU/1/12/780
Active substance : linagliptin/metformin hydrochloride
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10B - Blood glucose lowering drugs, excluding insulins
Chemical subgroup: A10BD - Combinations of oral blood glucose lowering drugs
Chemical substance: A10BD11 - Metformin and linagliptin
(See WHO ATC Index)
Indication: Treatment of adult patients with type 2 diabetes mellitus:Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Jentadueto is indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin and metformin alone do not provide adequate glycaemic control.
Marketing Authorisation Holder: Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
25/07/2012 Centralised - Authorisation EMEA/H/C/2279 (2012)5291 of 20/07/2012
21/09/2012 Centralised - Variation EMEA/H/C/2279/IB/2/G
Updated with Decision(2012)7754 of 25/10/2012
12/11/2012 Centralised - Variation (2012)7754 of 25/10/2012
19/03/2013 Centralised - Variation EMEA/H/C/2279/IB/7
Updated with Decision(2013)2410 of 22/04/2013
24/04/2013 Centralised - 2-Monthly update EMEA/H/C/2279/WS/351, 356 (2013)2410 of 22/04/2013
06/08/2013 Centralised - Notification EMEA/H/C/2279/N/11
Updated with Decision(2014)480 of 24/01/2014
30/08/2013 Centralised - Variation EMEA/H/C/2279/IG/350
Updated with Decision(2014)480 of 24/01/2014
28/01/2014 Centralised - 2-Monthly update EMEA/H/C/2279/II/12 (2014)480 of 24/01/2014
08/05/2014 Centralised - Variation EMEA/H/C/2279/IB/18/G
Updated with Decision(2015)3655 of 27/05/2015
25/09/2014 Centralised - Variation EMEA/H/C/2279/WS/524
Updated with Decision(2015)3655 of 27/05/2015
28/11/2014 Centralised - Notification EMEA/H/C/2279/N/25
Updated with Decision(2015)3655 of 27/05/2015
29/05/2015 Centralised - Yearly update (2015)3655 of 27/05/2015
22/10/2015 Centralised - Variation EMEA/H/C/2279/WS/800
Updated with Decision(2016)1331 of 26/02/2016
01/03/2016 Centralised - Yearly update (2016)1331 of 26/02/2016
07/03/2016 PSUSA - Modification EMEA/H/C/PSUSA/9214/201505 (2016)1445 of 02/03/2016
28/04/2016 Centralised - Variation EMEA/H/C/2279/II/31