This is a summary of the European public assessment report (EPAR) for Tesavel. 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 Tesavel.
Tesavel : EPAR - Summary for the public (PDF/56.72 KB)
First published: 08/12/2009
Last updated: 20/12/2012
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Diabetes Mellitus, Type 2
|Anatomical therapeutic chemical (ATC) code||
Merck Sharp & Dohme B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
26/03/2019 Tesavel - EMEA/H/C/000910 - N/0067
- 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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Drugs used in diabetes
For patients with type-2 diabetes mellitus, Tesavel 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 PPARγ agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ 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 agents do not provide adequate glycaemic control;
- a peroxisome-proliferator-activated-receptor-gamma (PPARγ) agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.
Tesavel is also indicated as add on to insulin (with or without metformin) when diet and exercise plus stable dosage of insulin 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