Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Tesavel   
Auth. number : EU/1/07/435
INN : sitagliptin
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: A10BH01 - Sitagliptin
(See WHO ATC Index)
Indication: For patients with type 2 diabetes mellitus, TESAVEL is indicated to improve glycaemic control and as add on to insulin when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Marketing Authorisation Holder: Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, 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
14/01/2008 Centralised - Authorisation EMEA/H/C/910 (2008)80 of 10/01/2008
04/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/910/IA/2
29/04/2008 Centralised - Variation EMEA/H/C/910/II/1 (2008)1735 of 25/04/2008
25/09/2008 Centralised - Notification EMEA/H/C/910/N/3
Updated with Decision(2009)4321 of 28/05/2009
01/06/2009 Centralised - Variation EMEA/H/C/910/II/5 (2009)4321 of 28/05/2009
10/08/2009 Centralised - Variation EMEA/H/C/910/II/6, 8 (2009)6353 of 06/08/2009
24/08/2009 Centralised - Variation EMEA/H/C/910/II/7 (2009)6584 of 20/08/2009
30/10/2009 Centralised - Variation EMEA/H/C/910/II/9 (2009)8518 of 28/10/2009
04/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/910/IG/16
20/08/2010 Centralised - Variation EMEA/H/C/910/WS/9 (2010)5849 of 18/08/2010
08/11/2010 Centralised - Variation EMEA/H/C/910/WS/25 (2010)7721 of 03/11/2010
21/11/2010 Centralised - Variation EMEA/H/C/910/IG/27/G
Updated with Decision(2011)925 of 09/02/2011
07/12/2010 Centralised - Variation EMEA/H/C/910/WS/46 (2010)8895 of 03/12/2010
04/01/2011 Centralised - Notification EMEA/H/C/910/N/10
Updated with Decision(2011)925 of 09/02/2011
09/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/910/IG/42
11/02/2011 Centralised - Variation (2011)925 of 09/02/2011
30/08/2011 Centralised - Notification EMEA/H/C/910/N/11
Updated with Decision(2011)6138 of 24/08/2011
30/08/2011 Centralised - Notification EMEA/H/C/910/N/13
Updated with Decision(2011)6138 of 24/08/2011
30/08/2011 Centralised - Variation EMEA/H/C/910/II/WS/129 (2011)6138 of 24/08/2011
21/12/2011 Centralised - Variation EMEA/H/C/910/II/WS/179 (2011)9942 of 19/12/2011
30/03/2012 Centralised - Variation EMEA/H/C/910/IB/27
Updated with Decision(2012)6709 of 20/09/2012
24/09/2012 Centralised - Renewal EMEA/H/C/910/R/29, EMEA/H/C/910/WS/281 (2012)6709 of 20/09/2012
02/01/2013 Centralised - Variation EMEA/H/C/910/WS/329 (2012)9932 of 20/12/2012
14/08/2013 Centralised - Variation EMEA/H/C//IG/339/G
Updated with Decision(2014)5256 of 18/07/2014
17/03/2014 Centralised - Variation EMEA/H/C/910/IG/413/G
Updated with Decision(2014)5256 of 18/07/2014
22/05/2014 Centralised - Variation EMEA/H/C/910/WS/558
Updated with Decision(2014)5256 of 18/07/2014
22/07/2014 Centralised - Yearly update (2014)5256 of 18/07/2014
25/09/2014 Centralised - Variation EMEA/H/C/910/WS/534