Ristfor

RSS

sitagliptin / metformin hydrochloride

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

Overview

This is a summary of the European public assessment report (EPAR) for Ristfor. 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 Ristfor.

This EPAR was last updated on 03/08/2018

Authorisation details

Product details
Name
Ristfor
Agency product number
EMEA/H/C/001235
Active substance
  • sitagliptin
  • metformin hydrochloride
International non-proprietary name (INN) or common name
sitagliptin / metformin hydrochloride
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BH01
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
15/03/2010
Contact address

Waarderweg 39
2031 BN Harlem
The Netherlands

Product information

29/06/2018 Ristfor - EMEA/H/C/001235 - T/0077

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:

  • Ristfor is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
  • Ristfor is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
  • Ristfor is indicated as triple combination therapy with a peroxisome proliferator-activated-receptor-gamma (PPARγ) agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.
  • Ristfor is also indicated as add-on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Assessment history

Changes since initial authorisation of medicine

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