Malta - English - Medicines Authority

merck healthcare kgaa frankfurter strasse 250, 64293 darmstadt, germany - sitagliptin, metformin hydrochloride - film-coated tablet - sitagliptin 50 mg metformin hydrochloride 1000 mg - drugs used in diabetes

Malta - English - Medicines Authority

doc generici srl via turati, 40-20121, milano, italy - sitagliptin, metformin hydrochloride - film-coated tablet - sitagliptin 50 mg metformin hydrochloride 850 mg - drugs used in diabetes

Malta - English - Medicines Authority

doc generici srl via turati, 40-20121, milano, italy - sitagliptin, metformin hydrochloride - film-coated tablet - sitagliptin 50 mg metformin hydrochloride 1000 mg - drugs used in diabetes

Malta - English - Medicines Authority

rafarm s.a. 12, korinthou str., 15451 neo psihiko, athens, greece - sitagliptin, metformin hydrochloride - film-coated tablet - sitagliptin 50 mg metformin hydrochloride 850 mg - drugs used in diabetes

Malta - English - Medicines Authority

rafarm s.a. 12, korinthou str., 15451 neo psihiko, athens, greece - sitagliptin, methionine - film-coated tablet - sitagliptin 50 mg methionine 1000 mg - drugs used in diabetes

Israel - English - Ministry of Health

teva israel ltd - sitagliptin as malate - film coated tablets - sitagliptin as malate 100 mg - sitagliptin - sitagliptin teva is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus. important limitations of use: sitagliptin teva should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis as it would not be effective in these settings.sitagliptin teva has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin teva.

Israel - English - Ministry of Health

teva israel ltd - sitagliptin as malate - film coated tablets - sitagliptin as malate 25 mg - sitagliptin - sitagliptin teva is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus. important limitations of use: sitagliptin teva should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis as it would not be effective in these settings.sitagliptin teva has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin teva.

Israel - English - Ministry of Health

teva israel ltd - sitagliptin as malate - film coated tablets - sitagliptin as malate 50 mg - sitagliptin - sitagliptin teva is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus. important limitations of use: sitagliptin teva should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis as it would not be effective in these settings.sitagliptin teva has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin teva.

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate - diabetes mellitus, type 2 - drugs used in diabetes - for adult patients with type 2 diabetes mellitus, sitagliptin sun 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 intolerance.- a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i.e. a thiazolidinedione) when use of a pparγ agonist is appropriate and when diet and exercise plus the pparγ agonist alone do not provide adequate glycaemic control.as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.- a pparγ agonist and metformin when use of a pparγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.sitagliptin sun is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

European Union - English - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - 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.sitagliptin/metformin hydrochloride mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparg) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparg agonist.sitagliptin/metformin hydrochloride mylan is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.