European Union - English - EMA (European Medicines Agency)

astra zeneca ab - saxagliptin, dapagliflozin propanediol monohydrate - diabetes mellitus, type 2; diabetes mellitus; nutritional and metabolic diseases; metabolic diseases; glucose metabolism disorders - drugs used in diabetes - qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin and/or sulphonylurea (su) and one of the monocomponents of qtern do not provide adequate glycaemic control,when already being treated with the free combination of dapagliflozin and saxagliptin.(see sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.)

European Union - English - myHealthbox

astrazeneca ab - metformin hydrochloride, dapagliflozin propanediol monohydrate - film-coated tablet (tablet) - 5 mg/850 mg - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose-lowering drugs - indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control - in patients inadequately controlled on their maximally tolerated dose of metformin alone - in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products - in patients already being treated with the combination of dapagliflozin and metformin as separate tablets

European Union - English - myHealthbox

astrazeneca ab - metformin hydrochloride, dapagliflozin propanediol monohydrate - film-coated tablet (tablet) - 5 mg/1,000 mg - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose-lowering drugs - indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control - in patients inadequately controlled on their maximally tolerated dose of metformin alone - in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products - in patients already being treated with the combination of dapagliflozin and metformin as separate tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - dapagliflozin - film-coated tablet - dapagliflozin

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - dapagliflozin - film-coated tablet - dapagliflozin

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

astrazeneca pty ltd - metformin hydrochloride, quantity: 1000 mg; dapagliflozin propanediol monohydrate, quantity: 12.3 mg (equivalent: dapagliflozin, qty 10 mg) - tablet, modified release - excipient ingredients: crospovidone; lactose; hypromellose; magnesium stearate; carmellose sodium; silicon dioxide; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - glycaemic control: xigduo xr is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control when treatment with both dapagliflozin and metformin is appropriate,prevention of hospitalisation for heart failure: xigduo xr is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure,(see section 5.1 pharmacodynamic properties ? clinical trials and 4.4 special warnings and precautions for use for available data on the combination therapy).

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

astrazeneca pty ltd - metformin hydrochloride, quantity: 500 mg; dapagliflozin propanediol monohydrate, quantity: 12.3 mg (equivalent: dapagliflozin, qty 10 mg) - tablet, modified release - excipient ingredients: microcrystalline cellulose; lactose; silicon dioxide; hypromellose; crospovidone; carmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - glycaemic control: xigduo xr is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control when treatment with both dapagliflozin and metformin is appropriate,prevention of hospitalisation for heart failure: xigduo xr is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure,(see section 5.1 pharmacodynamic properties ? clinical trials and 4.4 special warnings and precautions for use for available data on the combination therapy).

Canada - English - Health Canada

astrazeneca canada inc - dapagliflozin (dapagliflozin propanediol monohydrate) - tablet - 5mg - dapagliflozin (dapagliflozin propanediol monohydrate) 5mg - sodium-glucose cotransporter 2 (sglt2) inhibitors

Canada - English - Health Canada

astrazeneca canada inc - dapagliflozin (dapagliflozin propanediol monohydrate) - tablet - 10mg - dapagliflozin (dapagliflozin propanediol monohydrate) 10mg - sodium-glucose cotransporter 2 (sglt2) inhibitors

Canada - English - Health Canada

astrazeneca canada inc - dapagliflozin (dapagliflozin propanediol monohydrate); metformin hydrochloride - tablet - 5mg; 850mg - dapagliflozin (dapagliflozin propanediol monohydrate) 5mg; metformin hydrochloride 850mg - biguanides