Canada - English - Health Canada

apotex inc - sitagliptin (sitagliptin phosphate monohydrate) - tablet - 100mg - sitagliptin (sitagliptin phosphate monohydrate) 100mg

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

merck sharp & dohme (australia) pty ltd - metformin hydrochloride, quantity: 850 mg; sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium stearylfumarate; povidone; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - velmetia (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see sections 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration].

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

merck sharp & dohme (australia) pty ltd - metformin hydrochloride, quantity: 1000 mg; sitagliptin phosphate monohydrate, quantity: 128.5 mg (equivalent: sitagliptin, qty 100 mg) - tablet, modified release - excipient ingredients: povidone; hypromellose; colloidal anhydrous silica; sodium stearylfumarate; propyl gallate; macrogol 3350; kaolin; carnauba wax; titanium dioxide; hyprolose; indigo carmine aluminium lake - janumet xr (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see sections 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration].

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

merck sharp & dohme (australia) pty ltd - metformin hydrochloride, quantity: 1000 mg; sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg) - tablet, modified release - excipient ingredients: povidone; hypromellose; colloidal anhydrous silica; sodium stearylfumarate; propyl gallate; macrogol 3350; kaolin; carnauba wax; titanium dioxide; hyprolose; iron oxide yellow; indigo carmine aluminium lake - janumet xr (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see sections 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration].

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)

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.

Canada - English - Health Canada

apotex inc - sitagliptin (sitagliptin phosphate monohydrate); metformin hydrochloride - tablet (extended-release) - 50mg; 500mg - sitagliptin (sitagliptin phosphate monohydrate) 50mg; metformin hydrochloride 500mg

Canada - English - Health Canada

apotex inc - sitagliptin (sitagliptin phosphate monohydrate); metformin hydrochloride - tablet (extended-release) - 50mg; 1000mg - sitagliptin (sitagliptin phosphate monohydrate) 50mg; metformin hydrochloride 1000mg

Canada - English - Health Canada

apotex inc - sitagliptin (sitagliptin phosphate monohydrate); metformin hydrochloride - tablet (extended-release) - 100mg; 1000mg - sitagliptin (sitagliptin phosphate monohydrate) 100mg; metformin hydrochloride 1000mg

Canada - English - Health Canada

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