Tesavel

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sitagliptin

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 30/06/2022

Authorisation details

Product details
Name
Tesavel
Agency product number
EMEA/H/C/000910
Active substance
sitagliptin
International non-proprietary name (INN) or common name
sitagliptin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BH01
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
26
Date of issue of marketing authorisation valid throughout the European Union
10/01/2008
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

02/09/2021 Tesavel - EMEA/H/C/000910 - WS/2082

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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