Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Janumet   
Auth. number : EU/1/08/455
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 patients with type 2 diabetes mellitus:Janumet 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.Janumet 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.Janumet is indicated as triple combination therapy with a 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.Janumet 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 dosage 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
18/07/2008 Centralised - Authorisation EMEA/H/C/861 (2008)3868 of 16/07/2008
02/09/2008 Centralised - Variation EMEA/H/C/861/IA/2
22/10/2008 Corrigendum
11/12/2008 Centralised - Variation EMEA/H/C/861/IA/4
Updated with Decision(2009)4421 of 02/06/2009
11/12/2008 Centralised - Variation EMEA/H/C/861/IA/5
Updated with Decision(2009)4421 of 02/06/2009
03/03/2009 Centralised - Variation EMEA/H/C/861/IA/10
26/03/2009 Centralised - Variation EMEA/H/C/861/IB/8
26/03/2009 Centralised - Variation EMEA/H/C/861/IB/9
05/06/2009 Centralised - Variation EMEA/H/C/861/II/3 (2009)4421 of 02/06/2009
31/07/2009 Centralised - Variation EMEA/H/C/861/II/11 (2009)6191 of 29/07/2009
18/09/2009 Centralised - Variation EMEA/H/C/861/II/12 (2009)7094 of 16/09/2009
09/10/2009 Centralised - Variation EMEA/H/C/861/IA/15
20/10/2009 Centralised - Variation EMEA/H/C/861/IB/14
30/10/2009 Centralised - Variation EMEA/H/C/861/II/13 (2009)8503 of 28/10/2009
14/02/2010 Centralised - Variation EMEA/H/C/861/IG/46
07/05/2010 Centralised - Variation EMEA/H/C/861/IG/3
Updated with Decision(2010)5613 of 06/08/2010
12/05/2010 Centralised - Variation EMEA/H/C/861/IG/2
09/06/2010 Centralised - Variation EMEA/H/C/861/IG/8
04/08/2010 Centralised - Variation EMEA/H/C/861/IG/16
11/08/2010 Centralised - Variation EMEA/H/C/861/WS/9 (2010)5613 of 06/08/2010
05/11/2010 Centralised - Variation EMEA/H/C/861/WS/26 (2010)7742 of 03/11/2010
18/11/2010 Centralised - Variation EMEA/H/C/861/IG/27/G
Updated with Decision(2011)1201 of 21/02/2011
01/12/2010 Centralised - Variation EMEA/H/C/861/WS/46 (2010)8533 of 26/11/2010
15/12/2010 Centralised - Variation EMEA/H/C/861/N/16
Updated with Decision(2011)1201 of 21/02/2011
02/02/2011 Centralised - Variation EMEA/H/C/861/IG/42
24/02/2011 Centralised - Variation (2011)1201 of 21/02/2011
18/03/2011 Centralised - Variation EMEA/H/C/861/IG/55
20/05/2011 Centralised - Variation EMEA/H/C/861/N/17
Updated with Decision(2011)6152 of 24/08/2011
30/08/2011 Centralised - Variation EMEA/H/C/861/II/130/WS (2011)6152 of 24/08/2011
22/12/2011 Centralised - Variation EMEA/H/C/861/N/38
Updated with Decision(2012)6007 of 23/08/2012
28/08/2012 Centralised - Variation EMEA/H/C/861/WS/270/G (2012)6007 of 23/08/2012
20/12/2012 Centralised - Variation EMEA/H/C/861/WS/328 (2012)9867 of 18/12/2012
15/03/2013 Centralised - Renewal EMEA/H/C/861/R/47 (2013)1650 of 13/03/2013
24/05/2013 Centralised - Variation EMEA/H/C/861/IG/308
Updated with Decision(2014)3827 of 03/06/2014
24/05/2013 Centralised - Variation EMEA/H/C/861/IG/282
Updated with Decision(2014)3827 of 03/06/2014
23/08/2013 Centralised - Variation EMEA/H/C/861/N/53
Updated with Decision(2014)3827 of 03/06/2014
17/03/2014 Centralised - Variation EMEA/H/C/861/IG/414/G
Updated with Decision(2014)3827 of 03/06/2014
22/05/2014 Centralised - Variation EMEA/H/C/861/WS/559
05/06/2014 Centralised - Variation (2014)3827 of 03/06/2014