New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - dapagliflozin propanediol monohydrate 12.3mg equivalent to dapaglifozin 10mg;   - film coated tablet - 10 mg - active: dapagliflozin propanediol monohydrate 12.3mg equivalent to dapaglifozin 10mg   excipient: colloidal silicon dioxide crospovidone opadry ii yellow lactose magnesium stearate microcrystalline cellulose - monotherapy forxiga is indicated in adults with type 2 diabetes mellitus as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwise indicated but was not tolerated. initial combination forxiga is indicated in adults with type 2 diabetes mellitus as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycaemic control when diet and exercise have failed to provide adequate glycaemic control and there are poor prospects for response to metformin monotherapy. add-on combination forxiga is indicated in adult patients with type 2 diabetes mellitus in combination with other anti-hyperglycaemic agents to improve glycaemic control, when these together with diet and exercise do not provide adequate glycaemic control. prevention of hospitalisation for heart failure forxiga is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalisation for heart. prevention of new or worsening nephropathy forxiga is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease for the prevention of new or worsening nephropathy.

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propanediol monohydrate - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drugs used in diabetes - type 2 diabetes mellitusedistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas 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, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.heart failureedistride is indicated in adults for the treatment of symptomatic chronic heart failure.chronic kidney diseaseedistride is indicated in adults for the treatment of chronic kidney disease.

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propanediol monohydrate - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drugs used in diabetes - type 2 diabetes mellitusforxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas 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, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failure.chronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease.

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

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

Israel - English - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin propanediol - film coated tablets - dapagliflozin propanediol 12.30 mg/dose - dapagliflozin - type 2 diabetes mellitusforxiga is indicated in adults aged 18 years and older for 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.heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failurechronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease

Israel - English - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin propanediol - film coated tablets - dapagliflozin propanediol 6.150 mg/dose - dapagliflozin - type 2 diabetes mellitusforxiga is indicated in adults aged 18 years and older for 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.heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failurechronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease

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

cipla australia pty ltd - dapagliflozin propanediol monohydrate, quantity: 12.3 mg (equivalent: dapagliflozin, qty 10 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; copovidone; silicon dioxide; magnesium stearate; lactose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - type 2 diabetes mellitus glycaemic control,cipla dapagliflozin is indicated in adults with type 2 diabetes mellitus:,?as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwiseindicated but was not tolerated. ?as initial combination therapy with metformin, as an adjunct to diet and exercise, to improveglycaemic control when diet and exercise have failed to provide adequate glycaemic control andthere are poor prospects for response to metformin monotherapy (for example, high initialhaemoglobin a1c [hba1c] levels). ?in combination with other anti-hyperglycaemic agents to improve glycaemic control, when thesetogether with diet and exercise, do not provide adequate glycaemic control (see section 5.1pharmacodynamic properties ? clinical trials and section 4.4 special warnings and precautions foruse for available data on different add-on combination therapies).,prevention of hospitalisation for heart failure dapaglicip 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).,heart failure,dapaglicip is indicated in adults for the treatment of symptomatic heart failure with reduced ejection fraction, as an adjunct to standard of care therapy (see section 5.1 pharmacodynamic properties).,chronic kidney disease,dapaglicip is indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (ckd stage 2, 3 or 4 and urine acr greater than or equal 30 mg/g)

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

cipla australia pty ltd - dapagliflozin propanediol monohydrate, quantity: 12.3 mg (equivalent: dapagliflozin, qty 10 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; copovidone; silicon dioxide; magnesium stearate; lactose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - type 2 diabetes mellitus glycaemic control,cipla dapagliflozin is indicated in adults with type 2 diabetes mellitus:,?as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwiseindicated but was not tolerated. ?as initial combination therapy with metformin, as an adjunct to diet and exercise, to improveglycaemic control when diet and exercise have failed to provide adequate glycaemic control andthere are poor prospects for response to metformin monotherapy (for example, high initialhaemoglobin a1c [hba1c] levels). ?in combination with other anti-hyperglycaemic agents to improve glycaemic control, when thesetogether with diet and exercise, do not provide adequate glycaemic control (see section 5.1pharmacodynamic properties ? clinical trials and section 4.4 special warnings and precautions foruse for available data on different add-on combination therapies).,prevention of hospitalisation for heart failure dapaglicip 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).,heart failure,dapaglicip is indicated in adults for the treatment of symptomatic heart failure with reduced ejection fraction, as an adjunct to standard of care therapy (see section 5.1 pharmacodynamic properties).,chronic kidney disease,dapaglicip is indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (ckd stage 2, 3 or 4 and urine acr greater than or equal 30 mg/g)

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

cipla australia pty ltd - dapagliflozin propanediol monohydrate, quantity: 12.3 mg (equivalent: dapagliflozin, qty 10 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; copovidone; silicon dioxide; magnesium stearate; lactose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - type 2 diabetes mellitus glycaemic control,cipla dapagliflozin is indicated in adults with type 2 diabetes mellitus:,?as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwiseindicated but was not tolerated. ?as initial combination therapy with metformin, as an adjunct to diet and exercise, to improveglycaemic control when diet and exercise have failed to provide adequate glycaemic control andthere are poor prospects for response to metformin monotherapy (for example, high initialhaemoglobin a1c [hba1c] levels). ?in combination with other anti-hyperglycaemic agents to improve glycaemic control, when thesetogether with diet and exercise, do not provide adequate glycaemic control (see section 5.1pharmacodynamic properties ? clinical trials and section 4.4 special warnings and precautions foruse for available data on different add-on combination therapies).,prevention of hospitalisation for heart failure dapaglicip 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).,heart failure,dapaglicip is indicated in adults for the treatment of symptomatic heart failure with reduced ejection fraction, as an adjunct to standard of care therapy (see section 5.1 pharmacodynamic properties).,chronic kidney disease,dapaglicip is indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (ckd stage 2, 3 or 4 and urine acr greater than or equal 30 mg/g)

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

astrazeneca pty ltd - dapagliflozin propanediol monohydrate, quantity: 6.15 mg (equivalent: dapagliflozin, qty 5 mg); metformin hydrochloride, quantity: 1000 mg - tablet, modified release - excipient ingredients: carmellose sodium; lactose; hypromellose; silicon dioxide; crospovidone; magnesium stearate; microcrystalline cellulose; 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).