Janumet

RSS

sitagliptin / metformin

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

Overview

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

This EPAR was last updated on 01/08/2018

Authorisation details

Product details
Name
Janumet
Agency product number
EMEA/H/C/000861
Active substance
  • sitagliptin
  • metformin hydrochloride
International non-proprietary name (INN) or common name
sitagliptin / metformin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD07
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
15/07/2008
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

28/06/2018 Janumet - EMEA/H/C/000861 - T/0090

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:

  • Janumet 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.
  • Janumet 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.
  • Janumet is indicated as triple combination therapy with a PPAR  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 PPAR  agonist.
  • Janumet 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 dosage of insulin and metformin alone do not provide adequate glycaemic control.

Assessment history

Changes since initial authorisation of medicine

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