🇪🇺 DPP-4 inhibitor (sitagliptin) in European Union

EMA authorised DPP-4 inhibitor (sitagliptin) on 21 March 2007

Marketing authorisations

Application: EMEA/H/C/000762
Marketing authorisation holder: Merck Sharp & Dohme B.V.
Local brand name: Xelevia
Indication: For adult patients with type-2 diabetes mellitus, Xelevia 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

Application: EMEA/H/C/000896
Marketing authorisation holder: Merck Sharp and Dohme B.V
Local brand name: Efficib
Indication: For patients with type-2 diabetes mellitus: Efficib is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Efficib is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Efficib is indicated as triple combination therapy with a PPAR agonist (i
Status: approved

Application: EMEA/H/C/000862
Marketing authorisation holder: Merck Sharp & Dohme B.V.
Local brand name: Velmetia
Indication: For patients with type-2 diabetes mellitus: Velmetia is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Velmetia is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Velmetia is indicated as triple combination therapy with a PPAR agonist
Status: approved

Application: EMEA/H/C/001235
Marketing authorisation holder: Merck Sharp & Dohme B.V.
Local brand name: Ristfor
Indication: For patients with type-2 diabetes mellitus: Ristfor is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Ristfor is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Ristfor is indicated as triple combination therapy with a peroxisome prol
Status: approved

Application: EMEA/H/C/005678
Marketing authorisation holder: Mylan Pharmaceuticals Limited
Local brand name: Sitagliptin / Metformin hydrochloride Mylan
Indication: For adult patients with type 2 diabetes mellitus: Sitagliptin/Metformin hydrochloride Mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Sitagliptin/Metformin hydrochloride Mylan is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Status: approved

Application: EMEA/H/C/005598
Marketing authorisation holder: Accord Healthcare S.L.U.
Local brand name: Sitagliptin Accord
Indication: For adult patients with type 2 diabetes mellitus, Sitagliptin Accord 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 contraind
Status: approved

Application: EMEA/H/C/005850
Marketing authorisation holder: Accord Healthcare S.L.U.
Local brand name: Sitagliptin / Metformin hydrochloride Accord
Indication: For adult patients with type 2 diabetes mellitus: It is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. It is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. It is indicated as triple combination therapy with a peroxisome proliferator
Status: withdrawn

Application: EMEA/H/C/005778
Marketing authorisation holder: Sun Pharmaceutical Industries Europe B.V.
Local brand name: Sitagliptin / Metformin hydrochloride Sun
Indication: For adult patients with type 2 diabetes mellitus: Sitagliptin/Metformin hydrochloride SUN is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Sitagliptin/Metformin hydrochloride SUN is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Sit
Status: approved

Is DPP-4 inhibitor (sitagliptin) approved in European Union?

Yes. EMA authorised it on 21 March 2007; EMA authorised it on 15 July 2008; EMA authorised it on 16 July 2008.

Who is the marketing authorisation holder for DPP-4 inhibitor (sitagliptin) in European Union?

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