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

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

astrazeneca uk ltd - metformin hydrochloride; dapagliflozin propanediol monohydrate - tablet - 850mg ; 5mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

astrazeneca uk ltd - dapagliflozin propanediol monohydrate; metformin hydrochloride - tablet - 5mg ; 1gram

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propanediol monohydrate, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - type 2 diabetes mellitusfor the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.as monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.for study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.type 1 diabetes mellitusedistride is indicated in adults for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with bmi ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - metformin hydrochloride, dapagliflozin propanediol monohydrate - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - xigduo is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise:•    in patients insufficiently controlled on their maximally tolerated dose of metformin alone •    in combination with other medicinal products for the treatment of diabetes in patients insufficiently controlled with metformin and these medicinal products•    in patients already being treated with the combination of dapagliflozin and metformin as separate tablets.for study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

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

Canada - English - Health Canada

astrazeneca canada inc - dapagliflozin (dapagliflozin propanediol monohydrate); metformin hydrochloride - tablet - 5mg; 1000mg - dapagliflozin (dapagliflozin propanediol monohydrate) 5mg; metformin hydrochloride 1000mg - biguanides

Israel - English - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin propanediol; metformin hydrochloride - tablets extended release - metformin hydrochloride 1005.04 mg; dapagliflozin propanediol 12.30 mg - metformin and dapagliflozin - xigduo xr (dapagliflozin and metformin hcl extended-release) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin propanediol; metformin hydrochloride - tablets extended release - metformin hydrochloride 1005.04 mg; dapagliflozin propanediol 12.30 mg - metformin and dapagliflozin - xigduo xr (dapagliflozin and metformin hcl extended-release) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.שינוי משטר מינון 2/4/2019patients with renal impairement