ertugliflozin / metformin hydrochloride

This medicine is authorised for use in the European Union.


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 07/06/2023

Authorisation details

Product details
Agency product number
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
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

14/04/2023 Segluromet - EMEA/H/C/004314 - II/0017

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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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