Ristfor
sitagliptin / metformin hydrochloride
Table of contents
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 24/02/2021
Authorisation details
Product details | |
---|---|
Name |
Ristfor
|
Agency product number |
EMEA/H/C/001235
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
|
Anatomical therapeutic chemical (ATC) code |
A10BH01
|
Publication details | |
---|---|
Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
|
Revision |
23
|
Date of issue of marketing authorisation valid throughout the European Union |
15/03/2010
|
Contact address |
Product information
11/02/2021 Ristfor - EMEA/H/C/001235 - IG/1351/G
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
Pharmacotherapeutic group
Drugs used in diabetes
Therapeutic indication
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.