Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zomarist   
Auth. number : EU/1/08/483
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: Zomarist is indicated in the treatment of type 2 diabetes mellitus:
- Zomarist 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.
- Zomarist 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.
- Zomarist 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
03/12/2008 Centralised - Authorisation EMEA/H/C/1049 (2008)7921 of 01/12/2008
04/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1049/II/2
05/06/2009 Centralised - Notification EMEA/H/C/1049/N/1
Updated with Decision(2009)6824 of 02/09/2009
07/09/2009 Centralised - Variation EMEA/H/C/1049/II/3 (2009)6824 of 02/09/2009
14/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1049/IA/6
14/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1049/IA/8
14/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1049/IA/7
17/03/2010 Centralised - Variation EMEA/H/C/1049/II/9 (2010)1836 of 15/03/2010
04/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1049/IA/10
08/07/2010 Centralised - Variation EMEA/H/C/1049/WS/5 (2010)4787 of 05/07/2010
09/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1049/IB/11
13/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1049/IG/32
01/02/2011 Centralised - Variation EMEA/H/C/1049/WS/70 (2011)571 of 27/01/2011
18/04/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1049/IG/57/G
15/11/2011 Centralised - Variation EMEA/H/C/1049/WS/164 (2011)8253 of 10/11/2011
29/11/2011 Centralised - Variation EMEA/H/C/1049/WS/125 (2011)8860 of 24/11/2011
03/07/2012 Centralised - Variation EMEA/H/C/1049/WS/256 (2012)4604 of 28/06/2012
14/11/2012 Centralised - Variation EMEA/H/C/1049/WS/272, 257 (2012)7908 of 29/10/2012
08/02/2013 Centralised - Variation
Updated with Decision(2013)5137 of 31/07/2013
02/08/2013 Centralised - Renewal EMEA/H/C/1049/R/35 (2013)5137 of 31/07/2013
08/08/2013 Centralised - 2-Monthly update EMEA/H/C/1049/WS/358 (2013)5296 of 05/08/2013
25/04/2014 Centralised - Variation EMEA/H/C/1049/WS/518