Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Januvia   
Auth. number : EU/1/07/383
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, Januvia 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 (PPAR) agonist (i.e. a thiazolidinedione) when use of a PPAR agonist is appropriate and when diet and exercise plus the PPAR 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 PPAR agonist and metformin when use of a PPAR agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

Januvia 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/722 (2007)1362 of 21/03/2007
31/08/2007 Centralised - Variation EMEA/H/C/722/II/1 (2007)4111 of 29/08/2007
13/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/722/IA/4
21/12/2007 Centralised - Variation EMEA/H/C/722/II/2, 3 (2007)6775 of 19/12/2007
28/02/2008 Centralised - Variation EMEA/H/C/722/II/5 (2008)812 of 26/02/2008
25/09/2008 Centralised - Notification EMEA/H/C/722/N/6
Updated with Decision(2009)4403 of 02/06/2009
05/06/2009 Centralised - Variation EMEA/H/C/722/II/7 (2009)4403 of 02/06/2009
31/07/2009 Centralised - Variation EMEA/H/C/722/II/8, 10 (2009)6187 of 29/07/2009
25/08/2009 Centralised - Variation EMEA/H/C/722/II/9 (2009)6624 of 21/08/2009
11/11/2009 Centralised - Variation EMEA/H/C/722/II/11 (2009)8768 of 09/11/2009
04/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/722/IG/16
12/08/2010 Centralised - Variation EMEA/H/C/722/WS/9 (2010)5620 of 06/08/2010
08/11/2010 Centralised - Variation EMEA/H/C/722/WS/25 (2010)7723 of 03/11/2010
18/11/2010 Centralised - Variation EMEA/H/C/722/IG/27/G
Updated with Decision(2011)980 of 11/02/2011
01/12/2010 Centralised - Variation EMEA/H/C/722/WS/46 (2010)8525 of 26/11/2010
16/12/2010 Centralised - Notification EMEA/H/C/722/N/12
Updated with Decision(2011)980 of 11/02/2011
01/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/722/IG/42
15/02/2011 Centralised - Variation (2011)980 of 11/02/2011
24/05/2011 Centralised - Notification EMEA/H/C/722/N/13
Updated with Decision(2011)6150 of 24/08/2011
30/08/2011 Centralised - Variation EMEA/H/C/722/WS/129 (2011)6150 of 24/08/2011
05/01/2012 Centralised - Variation EMEA/H/C/722/WS/179 (2011)10091 of 22/12/2011
27/02/2012 Centralised - Renewal EMEA/H/C/722/R/14 (2012)1340 of 23/02/2012
03/09/2012 Centralised - Variation EMEA/H/C/722/WS/281 (2012)6131 of 30/08/2012
19/12/2012 Centralised - Variation EMEA/H/C/722/WS/329 (2012)9814 of 17/12/2012
14/08/2013 Centralised - Variation EMEA/H/C/722/IG/339/G
17/03/2014 Centralised - Variation EMEA/H/C/722/IG/413
22/05/2014 Centralised - Variation EMEA/H/C/722/WS/558