Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Eucreas   
Auth. number : EU/1/07/425
INN : vildagliptin / 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: A10BD08 - Metformin and vildagliptin
(See WHO ATC Index)
Indication: Eucreas is indicated in the treatment of type 2 diabetes mellitus:
- Eucreas is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
- Eucreas is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulphonylurea.
Eucreas is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
Marketing Authorisation Holder: Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

  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
16/11/2007 Centralised - Authorisation EMEA/H/C/807 (2007)5575 of 14/11/2007
15/02/2008 Centralised - Variation EMEA/H/C/807/II/1 (2008)681 of 13/02/2008
04/11/2008 Centralised - Variation EMEA/H/C/807/II/2 (2008)6606 of 30/10/2008
20/02/2009 Centralised - Variation EMEA/H/C/807/II/3
01/09/2009 Centralised - Variation EMEA/H/C/807/II/4 (2009)6720 of 28/08/2009
17/12/2009 Centralised - Variation EMEA/H/C/807/IA/6
17/12/2009 Centralised - Variation EMEA/H/C/807/IA/7
17/12/2009 Centralised - Variation EMEA/H/C/807/IA/7
17/03/2010 Centralised - Variation EMEA/H/C/807/II/9 (2010)1805 of 15/03/2010
03/06/2010 Centralised - Variation EMEA/H/C/807/IA/10
07/07/2010 Centralised - Variation EMEA/H/C/807/WS/5 (2010)4714 of 02/07/2010
13/07/2010 Centralised - Variation EMEA/H/C/807/IB/11
21/12/2010 Centralised - Variation EMEA/H/C/807/IG/32/G
27/01/2011 Centralised - Variation EMEA/H/C/807/WS/70 (2011)472 of 24/01/2011
18/04/2011 Centralised - Variation EMEA/H/C/807/IG/57/G
04/11/2011 Centralised - Variation EMEA/H/C/807/WS/164 (2011)7936 of 27/10/2011
28/11/2011 Centralised - Variation EMEA/H/C/807/WS/125 (2011)8843 of 24/11/2011
25/07/2012 Centralised - Renewal EMEA/H/C/807/R/25, EMEA/H/C/807/WS/256 (2012)5341 of 23/07/2012
29/10/2012 Centralised - Variation EMEA/H/C/807/WS/257, 272 (2012)7748 of 25/10/2012
05/02/2013 Centralised - Variation EMEA/H/C/807/IB/32/G
Updated with Decision(2013)5005 of 26/07/2013
30/07/2013 Centralised - Variation EMEA/H/C/807/WS/358 (2013)5005 of 26/07/2013
25/04/2014 Centralised - Variation EMEA/H/C/807/WS/518