Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ristfor   
Auth. number : EU/1/10/620
INN : sitagliptin / 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: A10BD07 - Metformin and sitagliptin
(See WHO ATC Index)
Indication: For adult patients with type 2 diabetes mellitus:
Ristfor is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
Ristfor is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Ristfor is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.
Ristfor is also indicated as add on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone 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/1235 (2010)1783 of 15/03/2010
07/05/2010 Centralised - Variation EMEA/H/C/1235/IG/3
Updated with Decision(2010)5609 of 06/08/2010
12/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1235/IG/2
09/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1235/IG/8
29/07/2010 Centralised - Notification EMEA/H/C/1235/N/1
Updated with Decision(2010)7739 of 03/11/2010
04/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1235/IG/16
11/08/2010 Centralised - Variation EMEA/H/C/1235/WS/9 (2010)5609 of 06/08/2010
09/11/2010 Centralised - Variation EMEA/H/C/1235/WS/26 (2010)7739 of 03/11/2010
18/11/2010 Centralised - Variation EMEA/H/C/1235/IG/27/G
Updated with Decision(2011)1200 of 21/02/2011
01/12/2010 Centralised - Variation EMEA/H/C/1235/WS/46 (2010)8565 of 26/11/2010
15/12/2010 Centralised - Notification EMEA/H/C/1235/N/2
Updated with Decision(2011)1200 of 21/02/2011
02/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1235/IG/42
14/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1235/IG/46
24/02/2011 Centralised - Variation (2011)1200 of 21/02/2011
18/03/2011 Centralised - Variation (refusal) EMEA/H/C/1235/IG/55
20/05/2011 Centralised - Notification EMEA/H/C/1235/N/3
Updated with Decision(2011)6158 of 24/08/2011
18/07/2011 Centralised - Notification EMEA/H/C/1235/N/4
Updated with Decision(2011)6158 of 24/08/2011
30/08/2011 Centralised - Variation EMEA/H/C/1235/WS/130 (2011)6158 of 24/08/2011
04/09/2012 Centralised - Variation EMEA/H/C/1235/WS/270/G (2012)6156 of 30/08/2012
20/12/2012 Centralised - Variation EMEA/H/C/1235/WS/328 (2012)9869 of 18/12/2012
24/05/2013 Centralised - Variation EMEA/H/C/1235/IG/308
Updated with Decision(2014)3830 of 03/06/2014
24/05/2013 Centralised - Variation EMEA/H/C/1235/IG/282
Updated with Decision(2014)3830 of 03/06/2014
29/05/2013 Centralised - Variation EMEA/H/C/1235/IB/36
Updated with Decision(2014)3830 of 03/06/2014
23/08/2013 Centralised - Notification EMEA/H/C/1235/N/39
Updated with Decision(2014)3830 of 03/06/2014
17/03/2014 Centralised - Variation EMEA/H/C/1235/IG/414/G
Updated with Decision(2014)3830 of 03/06/2014
22/05/2014 Centralised - Notification EMEA/H/C/1235/N/46
Updated with Decision(2014)10078 of 16/12/2014
22/05/2014 Centralised - Variation EMEA/H/C/1235/WS/559
Updated with Decision(2014)10078 of 16/12/2014
05/06/2014 Centralised - Yearly update (2014)3830 of 03/06/2014
25/09/2014 Centralised - Variation EMEA/H/C/1235/WS/535
Updated with Decision(2014)10078 of 16/12/2014
07/11/2014 Centralised - Variation EMEA/H/C/1235/IG/494
17/12/2014 Centralised - Renewal EMEA/H/C/1235/R/47 (2014)10078 of 16/12/2014