Den europeiske union - engelsk - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - icandra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone.in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets.in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

Den europeiske union - engelsk - EMA (European Medicines Agency)

takeda pharma a/s - alogliptin, pioglitazone - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - incresync is indicated as a second- or third-line treatment in adult patients aged 18 years and older with type-2 diabetes mellitus: , as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance;, in combination with metformin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone. , in addition, incresync can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18 years and older with type-2 diabetes mellitus already being treated with this combination. after initiation of therapy with incresync, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in hba1c). in patients who fail to show an adequate response, incresync should be discontinued. in light of potential risks with prolonged pioglitazone therapy, prescribers should confirm at subsequent routine reviews that the benefit of incresync is maintained (see section 4.4).,

Den europeiske union - engelsk - EMA (European Medicines Agency)

novo nordisk a/s - insulin human - diabetes mellitus - drugs used in diabetes - treatment of diabetes mellitus.

Den europeiske union - engelsk - EMA (European Medicines Agency)

janssen-cilag international nv - canagliflozin - diabetes mellitus, type 2 - drugs used in diabetes - invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes.for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.

Den europeiske union - engelsk - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin - diabetes mellitus, type 2 - dipeptidyl peptidase 4 (dpp-4) inhibitors, drugs used in diabetes - vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance.in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

Den europeiske union - engelsk - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sitagliptin, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - for patients with type 2 diabetes mellitus:janumet 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.janumet 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.janumet is indicated as triple combination therapy with a ppar  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 ppar  agonist.janumet 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 dosage of insulin and metformin alone do not provide adequate glycaemic control.

Den europeiske union - engelsk - EMA (European Medicines Agency)

merck sharp and dohme b.v - sitagliptin - diabetes mellitus, type 2 - drugs used in diabetes - for adult patients with type-2 diabetes mellitus, januvia 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;a 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.januvia 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.

Den europeiske union - engelsk - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - drugs used in diabetes - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. of the annex.heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease. 

Den europeiske union - engelsk - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - linagliptin, metformin - diabetes mellitus, type 2 - drugs used in diabetes, - treatment of adult patients with type-2 diabetes mellitus:jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.

Den europeiske union - engelsk - EMA (European Medicines Agency)

astrazeneca ab  - metformin hydrochloride, saxagliptin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - komboglyze is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets.komboglyze is also indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control.