Steglujan
ertugliflozin / sitagliptin
Table of contents
Overview
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.
Authorisation details
Product details | |
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Name |
Steglujan
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Agency product number |
EMEA/H/C/004313
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
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Anatomical therapeutic chemical (ATC) code |
A10BD24
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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 | |
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Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
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Revision |
7
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Date of issue of marketing authorisation valid throughout the European Union |
23/03/2018
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Contact address |
Product information
23/07/2020 Steglujan - EMEA/H/C/004313 - WS/1825
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
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Pharmacotherapeutic group
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Drugs used in diabetes
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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.