🇪🇺 DPP4 inhibitor in European Union

EMA authorised DPP4 inhibitor on 10 January 2008

Marketing authorisations

Application: EMEA/H/C/000910
Marketing authorisation holder: Merck Sharp & Dohme B.V.
Local brand name: Tesavel
Indication: For patients with type-2 diabetes mellitus, Tesavel is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or int
Status: approved

Application: EMEA/H/C/001234
Marketing authorisation holder: Merck Sharp & Dohme B.V.
Local brand name: Ristaben
Indication: For adult patients with type-2 diabetes mellitus, Ristaben is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications
Status: approved

Is DPP4 inhibitor approved in European Union?

Yes. EMA authorised it on 10 January 2008; EMA authorised it on 15 March 2010.

Who is the marketing authorisation holder for DPP4 inhibitor in European Union?

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