sitagliptin / metformin
This is a summary of the European public assessment report (EPAR) for Efficib. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Efficib.
Efficib : EPAR - Summary for the public (PDF/81.49 KB)
First published: 08/12/2009
Last updated: 05/07/2013
|Agency product number||
|International non-proprietary name (INN) or common name||
sitagliptin / metformin
|Therapeutic area (MeSH)||
Diabetes Mellitus, Type 2
|Anatomical therapeutic chemical (ATC) code||
Merck Sharp Dohme Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
22/05/2018 Efficib - EMEA/H/C/000896 - PSUSA/00002003/201708
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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For 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 PPAR 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 PPAR 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 dosage of insulin and metformin alone do not provide adequate glycaemic control.
European Medicines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type-2 diabetes26/03/2013