Steglujan

RSS

ertugliflozin / sitagliptin

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

Overview

An overview of Steglujan and why it is authorised in the EU

Steglujan is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes. It is used together with diet and exercise in the following patients:

  • patients whose blood glucose levels are not satisfactorily controlled with the diabetes medicines metformin and/or a sulphonylurea, in combination with either ertugliflozin or sitagliptin;
  • patients who are already taking ertugliflozin and sitagliptin as separate tablets.

Steglujan contains the active substances ertugliflozin and sitagliptin.

This EPAR was last updated on 07/09/2018

Authorisation details

Product details
Name
Steglujan
Agency product number
EMEA/H/C/004313
Active substance
  • ertugliflozin l-pyroglutamic acid
  • sitagliptin phosphate monohydrate
International non-proprietary name (INN) or common name
ertugliflozin / sitagliptin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD24
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
22/03/2018
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

23/08/2018 Steglujan - EMEA/H/C/004313 - T/0004

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

  • Combinations of oral blood glucose lowering drugs

Therapeutic indication

Steglujan is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:

  • when metformin and/or a sulphonylurea (SU) and one of the monocomponents of Steglujan do not provide adequate glycaemic control.
  • in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.

Assessment history

How useful was this page?

Add your rating