Segluromet

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ertugliflozin / metformin hydrochloride

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

Overview

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

Segluromet 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 glucose levels are not well controlled with the highest dose of metformin they can take
  • patients on the highest dose of metformin they can take who are also taking another diabetes medicine
  • 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 23/05/2018

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 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 Limited
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
22/03/2018
Contact address
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Product information

26/04/2018 Segluromet - EMEA/H/C/004314 - IB/0001/G

Contents

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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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