Steglatro

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ertugliflozin

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

Overview

Steglatro is a medicine used to control blood glucose (sugar) levels in 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.

This EPAR was last updated on 16/10/2018

Authorisation details

Product details
Name
Steglatro
Agency product number
EMEA/H/C/004315
Active substance
ertugliflozin l-pyroglutamic acid
International non-proprietary name (INN) or common name
ertugliflozin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BK04
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 B.V.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
20/03/2018
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

27/08/2018 Steglatro - EMEA/H/C/004315 - T/0002

Contents

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Pharmacotherapeutic group

  • Drugs used in diabetes

  • other blood glucose lowering drugs
  • excluding insulins

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.

Assessment history

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