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

sandoz pty ltd - sitagliptin hydrochloride monohydrate, quantity: 28.34 mg (equivalent: sitagliptin, qty 25 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; calcium hydrogen phosphate; sodium starch glycollate type a; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitagliptin sandoz pharma 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 sections 5.1 pharmacodynamic properties ? clinical trials and 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies].

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

Israel - English - Ministry of Health

teva israel ltd - sitagliptin as malate - film coated tablets - sitagliptin as malate 100 mg - sitagliptin - sitagliptin teva is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus. important limitations of use: sitagliptin teva should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis as it would not be effective in these settings.sitagliptin teva has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin teva.

Israel - English - Ministry of Health

teva israel ltd - sitagliptin as malate - film coated tablets - sitagliptin as malate 25 mg - sitagliptin - sitagliptin teva is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus. important limitations of use: sitagliptin teva should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis as it would not be effective in these settings.sitagliptin teva has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin teva.

Israel - English - Ministry of Health

teva israel ltd - sitagliptin as malate - film coated tablets - sitagliptin as malate 50 mg - sitagliptin - sitagliptin teva is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus. important limitations of use: sitagliptin teva should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis as it would not be effective in these settings.sitagliptin teva has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin teva.

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.