Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Xelevia   
Auth. number : EU/1/07/382
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 adult patients with type 2 diabetes mellitus, Xelevia is indicated to improve glycaemic control:

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 when diet and exercise plus metformin alone do not provide adequate glycaemic control.
• a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
• a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control.

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.
• a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

Xelevia is also indicated as add-on to insulin (with or without metformin) 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
23/03/2007 Centralised - Authorisation EMEA/H/C/762 (2007)1359 of 21/03/2007
31/08/2007 Centralised - Variation EMEA/H/C/762/II/1 (2007)4110 of 29/08/2007
06/11/2007 Centralised - Variation EMEA/H/C/762/IA/4
20/12/2007 Centralised - Variation EMEA/H/C/762/II/2, 3 (2007)6739 of 18/12/2007
28/02/2008 Centralised - Variation EMEA/H/C/762/II/5 (2008)817 of 26/02/2008
25/09/2008 Centralised - Variation EMEA/H/C/762/N/6
Updated with Decision(2009)4345 of 29/05/2009
10/03/2009 Centralised - Variation EMEA/H/C/762/N/8
Updated with Decision(2009)4345 of 29/05/2009
03/06/2009 Centralised - Variation EMEA/H/C/762/II/7 (2009)4345 of 29/05/2009
28/07/2009 Centralised - Variation EMEA/H/C/762/II/9, 11 (2009)5994 of 23/07/2009
01/09/2009 Centralised - Variation EMEA/H/C/762/II/10 (2009)6718 of 28/08/2009
30/10/2009 Centralised - Variation EMEA/H/C/762/II/12 (2009)8525 of 28/10/2009
29/07/2010 Centralised - Variation EMEA/H/C/762/N/26
Updated with Decision(2010)7719 of 03/11/2010
04/08/2010 Centralised - Variation EMEA/H/C/762/IG/16
10/08/2010 Centralised - Variation EMEA/H/C/762/WS/9 (2010)5596 of 06/08/2010
14/10/2010 Centralised - Variation EMEA/H/C/762/N/27
Updated with Decision(2010)8562 of 26/11/2010
08/11/2010 Centralised - Variation EMEA/H/C/762/WS/25 (2010)7719 of 03/11/2010
18/11/2010 Centralised - Variation EMEA/H/C/762/IG/27/G
Updated with Decision(2011)921 of 09/02/2011
01/12/2010 Centralised - Variation EMEA/H/C/762/WS/46 (2010)8562 of 26/11/2010
15/12/2010 Centralised - Variation EMEA/H/C/762/N/28
Updated with Decision(2011)921 of 09/02/2011
31/01/2011 Centralised - Variation EMEA/H/C/762/IG/42
11/02/2011 Centralised - Variation (2011)921 of 09/02/2011
20/05/2011 Centralised - Variation EMEA/H/C/762/N/29
Updated with Decision(2011)6522 of 13/09/2011
19/07/2011 Centralised - Variation EMEA/H/C/762/N/30
Updated with Decision(2011)6522 of 13/09/2011
15/09/2011 Centralised - Variation EMEA/H/C/762/WS/129 (2011)6522 of 13/09/2011
03/01/2012 Centralised - Variation EMEA/H/C/762/WS/179 (2011)10100 of 22/12/2011
25/01/2012 Centralised - Renewal EMEA/H/C/762/R/31 (2012)424 of 20/01/2012
12/09/2012 Centralised - Variation EMEA/H/C/762/WS/281 (2012)6395 of 10/09/2012
20/12/2012 Centralised - Variation EMEA/H/C/762/WS/329 (2012)9876 of 18/12/2012
14/08/2013 Centralised - Variation EMEA/H/C/762/IG/339/G
Updated with Decision(2014)5496 of 28/07/2014
17/03/2014 Centralised - Variation EMEA/H/C/762/IG/413/G
Updated with Decision(2014)5496 of 28/07/2014
22/05/2014 Centralised - Variation EMEA/H/C/762/WS/558
Updated with Decision(2014)5496 of 28/07/2014
29/07/2014 Centralised - Variation (2014)5496 of 28/07/2014