Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Xiliarx   
Auth. number : EU/1/08/486
INN : vildagliptin
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: A10BH02 - Vildagliptin
(See WHO ATC Index)
Indication: Vildagliptin is indicated in the treatment of type 2 diabetes mellitus in adults: As monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. As dual oral therapy in combination with metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin, a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance, a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate. As triple oral therapy in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Vildagliptin is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin 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
21/11/2008 Centralised - Authorisation EMEA/H/C/1051 (2008)7391 of 19/11/2008
06/08/2009 Centralised - Variation EMEA/H/C/1051/N/2
Updated with Decision(2011)7935 of 27/10/2011
27/08/2009 Centralised - Variation EMEA/H/C/1051/II/1 (2009)6664 of 25/08/2009
10/02/2010 Centralised - Variation EMEA/H/C/1051/IA/4
30/03/2010 Centralised - Variation EMEA/H/C/1051/II/5 (2010)2153 of 26/03/2010
07/07/2010 Centralised - Variation EMEA/H/C/1051/WS/6 (2010)4710 of 02/07/2010
13/01/2011 Centralised - Variation EMEA/H/C/1051/IG/32/G
27/01/2011 Centralised - Variation EMEA/H/C/1051/WS/70 (2011)456 of 24/01/2011
14/10/2011 Centralised - Variation EMEA/H/C/1051/WS/170 (2011)7396 of 12/10/2011
04/11/2011 Centralised - Variation EMEA/H/C/1051/WS/164 (2011)7935 of 27/10/2011
29/11/2011 Centralised - Variation EMEA/H/C/1051/WS/125, 149 (2011)8852 of 24/11/2011
13/12/2011 Corrigendum
13/12/2011 Corrigendum
01/02/2012 Centralised - Variation EMEA/H/C/1051/WS/187 (2012)588 of 30/01/2012
03/07/2012 Centralised - Variation EMEA/H/C/1051/WS/256 (2012)4569 of 28/06/2012
31/10/2012 Centralised - Variation EMEA/H/C/1051/WS/257, 272 (2012)7865 of 29/10/2012
05/08/2013 Centralised - Variation EMEA/H/C/1051/WS/358 (2013)5141 of 31/07/2013
29/11/2013 Centralised - Renewal EMEA/H/C/1051/R/30 (2013)8660 of 28/11/2013
25/04/2014 Centralised - Variation EMEA/H/C/1051/WS/518