Segluromet

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ertugliflozin / metformin hydrochloride

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

Overview

Segluromet is a medicine used to treat adults with type 2 diabetes together with diet and exercise.

Segluromet can be used alone or together with other diabetes medicines when glucose (sugar) levels in the blood are insufficiently controlled by other metformin-based treatments.

It can also be used as a replacement in patients who are already taking ertugliflozin and metformin as separate tablets.

Segluromet contains two active substances, ertugliflozin and metformin.

This EPAR was last updated on 16/02/2022

Authorisation details

Product details
Name
Segluromet
Agency product number
EMEA/H/C/004314
Active substance
  • ertugliflozin l-pyroglutamic acid
  • metformin hydrochloride
International non-proprietary name (INN) or common name
  • ertugliflozin
  • metformin hydrochloride
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD23
Additional monitoringAdditional 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
5
Date of issue of marketing authorisation valid throughout the European Union
23/03/2018
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

25/10/2021 Segluromet - EMEA/H/C/004314 - WS/1953

Other EU languages available icon This medicine’s product information is available in all official EU languages.
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Product information documents contain:

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

  • Drugs used in diabetes

  • Combinations of oral blood glucose lowering drugs

Therapeutic indication

Segluromet 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:

  • in patients not adequately controlled on their maximally tolerated dose of metformin alone
  • in patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetes
  • in patients already being treated with the combination of ertugliflozin and metformin as separate tablets.

Assessment history

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