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 16/07/2019

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 B.V.
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
15/03/2010
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

23/08/2018 Ristaben - EMEA/H/C/001234 - T/0057

Contents

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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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