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)

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.

Canada - English - Health Canada

sivem pharmaceuticals ulc - sitagliptin (sitagliptin phosphate monohydrate); metformin hydrochloride - tablet - 50mg; 850mg - sitagliptin (sitagliptin phosphate monohydrate) 50mg; metformin hydrochloride 850mg

Canada - English - Health Canada

sivem pharmaceuticals ulc - sitagliptin (sitagliptin phosphate monohydrate); metformin hydrochloride - tablet - 50mg; 500mg - sitagliptin (sitagliptin phosphate monohydrate) 50mg; metformin hydrochloride 500mg

Canada - English - Health Canada

sivem pharmaceuticals ulc - sitagliptin (sitagliptin phosphate monohydrate); metformin hydrochloride - tablet - 50mg; 1000mg - sitagliptin (sitagliptin phosphate monohydrate) 50mg; metformin hydrochloride 1000mg

Canada - English - Health Canada

mantra pharma inc - sitagliptin (sitagliptin phosphate) - tablet - 25mg - sitagliptin (sitagliptin phosphate) 25mg

Canada - English - Health Canada

mantra pharma inc - sitagliptin (sitagliptin phosphate) - tablet - 50mg - sitagliptin (sitagliptin phosphate) 50mg

Canada - English - Health Canada

mantra pharma inc - sitagliptin (sitagliptin phosphate) - tablet - 100mg - sitagliptin (sitagliptin phosphate) 100mg

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

arrotex pharmaceuticals pty ltd - sitagliptin phosphate monohydrate, quantity: 32.125 mg (equivalent: sitagliptin, qty 25 mg) - tablet - excipient ingredients: iron oxide red; purified talc; titanium dioxide; hyprolose; croscarmellose sodium; hypromellose; macrogol 8000; microcrystalline cellulose; magnesium stearate; iron oxide yellow; calcium hydrogen phosphate - sitagliptin is indicated for the treatment of diabetes mellitus type 2 in persons 18 years of age and older who have failed dietary measures and exercise:,- as monotherapy, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus, when metformin cannot be used.,- as dual combination therapy, with metformin, or with a sulfonylurea, or with a thiazolidinedione where the use of a thiazolidinedione is considered appropriate.,- as triple combination therapy with metformin and a sulfonylurea when combination therapy with both agents does not provide adequate glycaemic control.,- as add-on combination therapy with insulin (with or without metformin).