Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Efficib   
Auth. number : EU/1/08/457
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:
Efficib 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.
Efficib 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.
Efficib 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.
Efficib 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
18/07/2008 Centralised - Authorisation EMEA/H/C/896 (2008)3867 of 16/07/2008
02/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/896/IA/3
22/10/2008 Corrigendum
13/11/2008 Centralised - Notification EMEA/H/C/896/N/2
Updated with Decision(2009)4420 of 02/06/2009
12/12/2008 Centralised - Variation EMEA/H/C/896/IA/6
Updated with Decision(2009)4420 of 02/06/2009
12/12/2008 Centralised - Variation EMEA/H/C/896/IA/5
Updated with Decision(2009)4420 of 02/06/2009
03/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/896/IA/11
26/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/896/IB/9
15/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/896/IB/10
05/06/2009 Centralised - Variation EMEA/H/C/896/II/4 (2009)4420 of 02/06/2009
31/07/2009 Centralised - Variation EMEA/H/C/896/II/14 (2009)6193 of 29/07/2009
18/09/2009 Centralised - Variation EMEA/H/C/896/II/12 (2009)7090 of 16/09/2009
09/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/896/IA/16
20/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/896/IB/15
30/10/2009 Centralised - Variation EMEA/H/C/896/II/13 (2009)8504 of 28/10/2009
07/05/2010 Centralised - Variation EMEA/H/C/896/IG/3
Updated with Decision(2010)5612 of 06/08/2010
12/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/896/IG/2
09/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/896/IG/8
04/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/896/IG/16
11/08/2010 Centralised - Variation EMEA/H/C/896/WS/9 (2010)5612 of 06/08/2010
05/11/2010 Centralised - Variation EMEA/H/C/896/WS/26 (2010)7740 of 03/11/2010
18/11/2010 Centralised - Variation EMEA/H/C/896/IG/27/G
Updated with Decision(2011)1202 of 21/02/2011
01/12/2010 Centralised - Variation EMEA/H/C/896/WS/46 (2010)8531 of 26/11/2010
15/12/2010 Centralised - Notification EMEA/H/C/896/N/17
Updated with Decision(2011)1202 of 21/02/2011
02/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/896/IG/42
14/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/896/IG/46
24/02/2011 Centralised - Variation (2011)1202 of 21/02/2011
18/03/2011 Centralised - Variation (refusal) EMEA/H/C/896/IG/55
20/05/2011 Centralised - Notification EMEA/H/C/896/N/18
Updated with Decision(2011)6154 of 24/08/2011
18/07/2011 Centralised - Notification EMEA/H/C/896/N/19
Updated with Decision(2011)6154 of 24/08/2011
30/08/2011 Centralised - Variation EMEA/H/C/896/WS/130 (2011)6154 of 24/08/2011
28/08/2012 Centralised - Variation EMEA/H/C/896/WS/270/G (2012)6005 of 23/08/2012
20/12/2012 Centralised - Variation EMEA/H/C/896/WS/328 (2012)9868 of 18/12/2012
15/03/2013 Centralised - Renewal EMEA/H/C/896/R/47 (2013)1649 of 13/03/2013
24/05/2013 Centralised - Variation EMEA/H/C/896/IG/282
Updated with Decision(2014)3829 of 03/06/2014
24/05/2013 Centralised - Variation EMEA/H/C/896/IG/308
Updated with Decision(2014)3829 of 03/06/2014
23/08/2013 Centralised - Notification EMEA/H/C/896/N/54
Updated with Decision(2014)3829 of 03/06/2014
17/03/2014 Centralised - Variation EMEA/H/C/896/IG/414/G
Updated with Decision(2014)3829 of 03/06/2014
22/05/2014 Centralised - Variation EMEA/H/C/896/WS/559
05/06/2014 Centralised - Yearly update (2014)3829 of 03/06/2014
25/09/2014 Centralised - Variation EMEA/H/C/896/WS/535