Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ristaben   
Auth. number : EU/1/10/621
Active substance : 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, Ristaben 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 intolererance.
= 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 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 agents 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 agents do not provide adequate glycaemic control.
Ristaben is also indicated as add on to insulin (with or without metformin) when diet and exercise plus stable dosage 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
17/03/2010 Centralised - Authorisation EMEA/H/C/1234 (2010)1782 of 15/03/2010
29/07/2010 Centralised - Notification EMEA/H/C/1234/N/1
Updated with Decision(2010)7727 of 03/11/2010
04/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1234/IG/16
11/08/2010 Centralised - Variation EMEA/H/C/1234/WS/9 (2010)5608 of 06/08/2010
09/11/2010 Centralised - Variation EMEA/H/C/1234/WS/25 (2010)7727 of 03/11/2010
18/11/2010 Centralised - Variation EMEA/H/C/1234/IG/27/G
Updated with Decision(2011)1199 of 21/02/2011
01/12/2010 Centralised - Variation EMEA/H/C/1234/WS/46 (2010)8567 of 26/11/2010
15/12/2010 Centralised - Notification EMEA/H/C/1234/N/2
Updated with Decision(2011)1199 of 21/02/2011
02/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1234/IG/42
24/02/2011 Centralised - Variation (2011)1199 of 21/02/2011
20/05/2011 Centralised - Notification EMEA/H/C/1234/N/3
Updated with Decision(2011)6157 of 24/08/2011
18/07/2011 Centralised - Notification EMEA/H/C/1234/N/4
Updated with Decision(2011)6157 of 24/08/2011
30/08/2011 Centralised - Variation EMEA/H/C/1234/WS/129 (2011)6157 of 24/08/2011
03/01/2012 Centralised - Variation EMEA/H/C/1234/WS/179 (2011)10114 of 22/12/2011
02/04/2012 Centralised - Variation EMEA/H/C/1234/IB/18
Updated with Decision(2012)6158 of 30/08/2012
05/09/2012 Centralised - Variation EMEA/H/C/1234/WS/281 (2012)6158 of 30/08/2012
20/12/2012 Centralised - Variation EMEA/H/C/1234/WS/329 (2012)9873 of 18/12/2012
14/08/2013 Centralised - Variation EMEA/H/C/1234/IG/339/G
Updated with Decision(2014)6033 of 19/08/2014
17/03/2014 Centralised - Variation EMEA/H/C/1234/IG/413/G
Updated with Decision(2014)6033 of 19/08/2014
20/05/2014 Centralised - Notification EMEA/H/C/1234/N/32
Updated with Decision(2014)6033 of 19/08/2014
22/05/2014 Centralised - Variation EMEA/H/C/1234/WS/558
Updated with Decision(2014)6033 of 19/08/2014
21/08/2014 Centralised - Yearly update (2014)6033 of 19/08/2014
25/09/2014 Centralised - Variation EMEA/H/C/1234/WS/534
Updated with Decision(2014)1077 of 16/12/2014
07/11/2014 Centralised - Variation EMEA/H/C/1234/IG/494
19/12/2014 Centralised - Renewal EMEA/H/C/1234/R/33 (2014)1077 of 16/12/2014