Steglatro
ertugliflozin
Table of contents
Overview
Steglatro is a medicine used to treat adults with type 2 diabetes together with diet and exercise.
Steglatro can be used in combination with other diabetes medicines or on its own in patients who cannot take metformin.
Steglatro contains the active substance ertugliflozin.
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List item
Steglatro : EPAR - Medicine overview (PDF/144.33 KB)
First published: 05/04/2018
Last updated: 16/02/2022
EMA/90284/2018 -
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List item
Steglatro : EPAR - Risk management plan summary (PDF/186.55 KB)
First published: 16/02/2022
Authorisation details
Product details | |
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Name |
Steglatro
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Agency product number |
EMEA/H/C/004315
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Active substance |
ertugliflozin l-pyroglutamic acid
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International non-proprietary name (INN) or common name |
ertugliflozin
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Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
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Anatomical therapeutic chemical (ATC) code |
A10BK04
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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 |
8
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Date of issue of marketing authorisation valid throughout the European Union |
21/03/2018
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Contact address |
Waarderweg 39 |
Product information
05/12/2022 Steglatro - EMEA/H/C/004315 - IAIN/016/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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Drugs used in diabetes
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Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Therapeutic indication
Steglatro 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:
- as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.
- in addition to other medicinal products for the treatment of diabetes.