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

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg); metformin hydrochloride, quantity: 1000 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; sodium stearylfumarate; povidone; 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 - sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg); metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: povidone; microcrystalline cellulose; sodium stearylfumarate; 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].

Ireland - English - HPRA (Health Products Regulatory Authority)

rowa pharmaceuticals limited - sitagliptin hydrochloride monohydrate; metformin hydrochloride - film-coated tablet - metformin and sitagliptin

Ireland - English - HPRA (Health Products Regulatory Authority)

rowa pharmaceuticals limited - sitagliptin hydrochloride monohydrate; metformin hydrochloride - film-coated tablet - metformin and sitagliptin

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, sitagliptin hydrochloride monohydrate - diabetes mellitus, type 2 - drugs used in diabetes - for adult patients with type 2 diabetes mellitus:it 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.it 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.it 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.it 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.

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

arrotex pharmaceuticals pty ltd - sitagliptin phosphate monohydrate, quantity: 128.5 mg (equivalent: sitagliptin, qty 100 mg) - tablet - excipient ingredients: iron oxide yellow; macrogol 8000; microcrystalline cellulose; iron oxide red; titanium dioxide; calcium hydrogen phosphate; magnesium stearate; hyprolose; hypromellose; croscarmellose sodium; purified talc - 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).

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

sandoz pty ltd - metformin hydrochloride, quantity: 850 mg; sitagliptin hydrochloride monohydrate, quantity: 56.69 mg (equivalent: sitagliptin, qty mg) - tablet, film coated - excipient ingredients: hypromellose; sodium lauryl sulfate; croscarmellose sodium; povidone; sodium stearylfumarate; hyprolose; titanium dioxide; iron oxide red; triethyl citrate; purified talc; microcrystalline cellulose; iron oxide yellow - sitagliptin/metformin sandoz 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.

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

sandoz pty ltd - metformin hydrochloride, quantity: 1000 mg; sitagliptin hydrochloride monohydrate, quantity: 56.69 mg (equivalent: sitagliptin, qty mg) - tablet, film coated - excipient ingredients: iron oxide yellow; titanium dioxide; hyprolose; povidone; iron oxide red; sodium lauryl sulfate; triethyl citrate; purified talc; microcrystalline cellulose; sodium stearylfumarate; hypromellose; croscarmellose sodium - sitagliptin/metformin sandoz 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.

Canada - English - Health Canada

auro pharma inc - sitagliptin (sitagliptin hydrochloride monohydrate) - tablet - 25mg - sitagliptin (sitagliptin hydrochloride monohydrate) 25mg

Canada - English - Health Canada

auro pharma inc - sitagliptin (sitagliptin hydrochloride monohydrate) - tablet - 50mg - sitagliptin (sitagliptin hydrochloride monohydrate) 50mg