Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Icandra   
Auth. number : EU/1/08/484
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: Treatment of type 2 diabetes mellitus 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.
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
03/12/2008 Centralised - Authorisation EMEA/H/C/1050 (2008)7922 of 01/12/2008
06/02/2009 Centralised - Variation EMEA/H/C/1050/IB/1
Updated with Decision(2009)6745 of 31/08/2009
04/06/2009 Centralised - Variation EMEA/H/C/1050/II/2
02/09/2009 Centralised - Variation EMEA/H/C/1050/II/3 (2009)6745 of 31/08/2009
14/12/2009 Centralised - Variation EMEA/H/C/1050/IA/8
16/12/2009 Centralised - Variation EMEA/H/C/1050/IA/7
16/12/2009 Centralised - Variation EMEA/H/C/1050/IA/6
23/03/2010 Centralised - Variation EMEA/H/C/1050/II/9 (2010)1835 of 15/03/2010
08/06/2010 Centralised - Variation EMEA/H/C/1050/IA/10
08/07/2010 Centralised - Variation EMEA/H/C/1050/WS/5 (2010)4789 of 05/07/2010
09/07/2010 Centralised - Variation EMEA/H/C/1050/IB/11
13/01/2011 Centralised - Variation EMEA/H/C/1050/IG/32
01/02/2011 Centralised - Variation EMEA/H/C/1050/WS/70 (2011)570 of 27/01/2011
18/04/2011 Centralised - Variation EMEA/H/C/1050/IG/57/G
26/10/2011 Centralised - Variation EMEA/H/C/1050/WS/164 (2011)7792 of 24/10/2011
30/11/2011 Centralised - Variation EMEA/H/C/1050/WS/125 (2011)8861 of 24/11/2011
03/07/2012 Centralised - Variation EMEA/H/C/1050/WS/250 (2012)4603 of 28/06/2012
14/11/2012 Centralised - Variation EMEA/H/C/1050/WS/272, 257 (2012)7907 of 29/10/2012
08/02/2013 Centralised - Variation
Updated with Decision(2013)5138 of 31/07/2013
05/08/2013 Centralised - Renewal EMEA/H/C/1050/R/35 (2013)5138 of 31/07/2013
08/08/2013 Centralised - Variation EMEA/H/C/1050/WS/358 (2013)5291 of 05/08/2013
25/04/2014 Centralised - Variation EMEA/H/C/1050/WS/518