Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Trajenta   
Auth. number : EU/1/11/707
Active substance : linagliptin
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: A10BH - Dipeptidyl peptidase 4 (dpp-4) inhibitors
Chemical substance: A10BH05 - Linagliptin
(See WHO ATC Index)
Indication: Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:

as monotherapy
• in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.

as combination therapy
• in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
• in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
• in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does 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
30/08/2011 Centralised - Authorisation EMEA/H/C/707 (2011)6180 of 24/08/2011
18/01/2012 Corrigendum (2012)197 of 13/01/2012
13/03/2012 Centralised - Notification EMEA/H/C/707/N/1
Updated with Decision(2012)7656 of 24/10/2012
26/10/2012 Centralised - Variation EMEA/H/C/707/II/4/G (2012)7656 of 24/10/2012
24/04/2013 Centralised - 2-Monthly update EMEA/H/C/707/WS/351, 356 (2013)2402 of 22/04/2013
06/08/2013 Centralised - Notification EMEA/H/C/2110/N/10
Updated with Decision(2014)6798 of 18/09/2014
30/08/2013 Centralised - Variation EMEA/H/C/IG/350
Updated with Decision(2014)6798 of 18/09/2014
22/09/2014 Centralised - Yearly update (2014)6798 of 18/09/2014
25/09/2014 Centralised - Variation EMEA/H/C/2110/WS/524
Updated with Decision(2015)6680 of 23/09/2015
27/11/2014 Centralised - Notification EMEA/H/C/2110/N/17
Updated with Decision(2015)6680 of 23/09/2015
15/07/2015 Centralised - Notification EMEA/H/C/2110/N/19
Updated with Decision(2015)6680 of 23/09/2015
25/09/2015 Centralised - Yearly update (2015)6680 of 23/09/2015
22/02/2016 PSUSA - Modification EMEA/H/C/PSUSA/1886/201505 (2016)1139 of 18/02/2016
29/03/2016 Centralised - Renewal EMEA/H/C/2110/R/21 (2016)1913 of 22/03/2016
28/04/2016 Centralised - Variation EMEA/H/C/2110/II/23