🇪🇺 SGLT2 inhibitor in European Union

EMA authorised SGLT2 inhibitor on 23 March 2018

Marketing authorisations

Application: EMEA/H/C/004313
Marketing authorisation holder: Merck Sharp & Dohme B.V.
Local brand name: Steglujan
Indication: Steglujan 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: when metformin and/or a sulphonylurea (SU) and one of the monocomponents of Steglujan do not provide adequate glycaemic control. in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.
Status: approved

Application: EMEA/H/C/004314
Marketing authorisation holder: Merck Sharp & Dohme B.V.
Local brand name: Segluromet
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.
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is SGLT2 inhibitor approved in European Union?

Yes. EMA authorised it on 23 March 2018; EMA authorised it on 23 March 2018.

Who is the marketing authorisation holder for SGLT2 inhibitor in European Union?

Merck Sharp & Dohme B.V. holds the EU marketing authorisation.