Ristaben

RSS

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 Ristaben. 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 Ristaben.

This EPAR was last updated on 22/06/2018

Authorisation details

Product details
Name
Ristaben
Agency product number
EMEA/H/C/001234
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 Ltd
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
15/03/2010
Contact address
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Product information

22/05/2018 Ristaben - EMEA/H/C/001234 - PSUSA/00002711/201708

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 diabtetes

Therapeutic indication

For adult patients with type-2 diabetes mellitus, Ristaben 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 peroxisome proliferator-activated-receptor-gamma (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 medicinal products do not provide adequate glycaemic control;
    • a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

Ristaben is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Assessment history

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