Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Steglatro   
Auth. number : EU/1/18/1267
Active substance : ertugliflozin
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10B - Blood glucose lowering drugs, excluding insulins
Chemical subgroup: A10BK - Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Chemical substance: A10BK04 - ertugliflozin
(See WHO ATC Index)
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.
(For study results with respect to combinations and effects on glycaemic control see sections 4.4, 4.5, and 5.1.)
Marketing Authorisation Holder: Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/03/2018 Centralised - Authorisation EMEA/H/C/4315 (2018)1903 of 21/03/2018
26/04/2018 Centralised - Variation EMEA/H/C/4315/IB/1/G
Updated with Decision(2018)5789 of 28/08/2018
30/08/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/4315/T/2 (2018)5789 of 28/08/2018