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

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.

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - 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.sitagliptin/metformin hydrochloride sun is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) 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 pparγ agonist.sitagliptin/metformin hydrochloride sun 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.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - 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 contraindications or intolerance.- a peroxisome proliferator-activated receptor gamma (ppary) agonist (i.e. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary 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 ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.sitagliptin accord 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)

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.

Australia - English - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - sitagliptin hydrochloride monohydrate, quantity: 27.25 mg (equivalent: sitagliptin, qty 25 mg) - tablet, film coated - excipient ingredients: sodium stearylfumarate; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; calcium hydrogen phosphate dihydrate; povidone; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - sitagliptin pcor is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,- monotherapy when metformin is considered inappropriate due to intolerance; or,- in combination with other anti-hyperglycaemic agents, including insulin,[see 5.1 pharmacodynamic properties, clinical trials, 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies].