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 11/06/2019

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
21
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

26/03/2019 Tesavel - EMEA/H/C/000910 - N/0067

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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