This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 06/12/2022

Authorisation details

Product details
Agency product number
Active substance
ertugliflozin l-pyroglutamic acid
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
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.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

05/12/2022 Steglatro - EMEA/H/C/004315 - IAIN/016/G

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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

  • 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.

Assessment history

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