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

astrazeneca pty ltd - dapagliflozin propanediol monohydrate, quantity: 12.3 mg (equivalent: dapagliflozin, qty 10 mg); saxagliptin, quantity: 5 mg - tablet - excipient ingredients: microcrystalline cellulose; magnesium stearate; lactose; croscarmellose sodium; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; indigo carmine aluminium lake; ethanol; shellac; sulfuric acid - qtern 5/10 is indicated as an adjunct to diet and exercise, in combination with metformin, to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and dapagliflozin is appropriate.

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

astrazeneca pty ltd - dapagliflozin propanediol monohydrate, quantity: 12.3 mg (equivalent: dapagliflozin, qty 10 mg) - tablet, film coated - excipient ingredients: silicon dioxide; microcrystalline cellulose; magnesium stearate; crospovidone; purified water; lactose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - type 2 diabetes mellitus,glycaemic control,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.,? 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 (for example, high initial haemoglobin a1c [hba1c] levels).,? in combination with other anti-hyperglycaemic agents to improve glycaemic control, when these together with diet and exercise, do not provide adequate glycaemic control (see section 5.1 pharmacodynamic properties ? clinical trials and section 4.4 special warnings and precautions for use for available data on different add-on combination therapies).,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 hospitalization for heart failure (see section 5.1 pharmacodynamic properties ? clinical trials). heart failure,forxiga is indicated in adults for the treatment of symptomatic heart failure independent of left ventricular ejection fraction, as an adjunct to standard of care therapy (see section 5.1 pharmacodynamic properties). chronic kidney disease,forxiga 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 ? 30 mg/g)

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - dapagliflozin propanediol monohydrate 12.3mg equivalent to dapagliflozin 10 mg;  ; metformin hydrochloride 1000mg (with 0.5% magnesium stearate);   - modified release tablet - 10mg/1000mg - active: dapagliflozin propanediol monohydrate 12.3mg equivalent to dapagliflozin 10 mg   metformin hydrochloride 1000mg (with 0.5% magnesium stearate)   excipient: carmellose sodium colloidal silicon dioxide crospovidone hypromellose lactose magnesium stearate microcrystalline cellulose opadry yellow 85f12372 - glycaemic control xigduo xr is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control when treatment with both dapagliflozin and metformin is appropriate (see sections 5.1 and 4.4 for available data on the combination therapy). prevention of hospitalisation for heart failure dapagliflozin 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 failure (see section 5.1 pharmacodynamic properties – clinical efficacy and safety). prevention of new or worsening nephropathy dapagliflozin 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 (see section 5.1 pharmacodynamic properties – clinical efficacy and safety).

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - dapagliflozin propanediol monohydrate 12.3mg equivalent to dapagliflozin 10 mg;  ; metformin hydrochloride 500mg (with 0.5% magnesium stearate);   - modified release tablet - 10mg/500mg - active: dapagliflozin propanediol monohydrate 12.3mg equivalent to dapagliflozin 10 mg   metformin hydrochloride 500mg (with 0.5% magnesium stearate)   excipient: carmellose sodium colloidal silicon dioxide crospovidone hypromellose microcrystalline cellulose (ph302) hypromellose (2910) lactose magnesium stearate microcrystalline cellulose opadry pink 85f94333 - glycaemic control xigduo xr is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control when treatment with both dapagliflozin and metformin is appropriate (see sections 5.1 and 4.4 for available data on the combination therapy). prevention of hospitalisation for heart failure dapagliflozin 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 failure (see section 5.1 pharmacodynamic properties – clinical efficacy and safety). prevention of new or worsening nephropathy dapagliflozin 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 (see section 5.1 pharmacodynamic properties – clinical efficacy and safety).

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - dapagliflozin propanediol monohydrate 6.15mg equivalent to dapagliflozin 5 mg;  ; metformin hydrochloride 1000mg (with 0.5% magnesium stearate);   - modified release tablet - 5mg/1000mg - active: dapagliflozin propanediol monohydrate 6.15mg equivalent to dapagliflozin 5 mg   metformin hydrochloride 1000mg (with 0.5% magnesium stearate)   excipient: carmellose calcium colloidal silicon dioxide crospovidone hypromellose lactose magnesium stearate microcrystalline cellulose opadry pink 85f94592 - glycaemic control xigduo xr is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control when treatment with both dapagliflozin and metformin is appropriate (see sections 5.1 and 4.4 for available data on the combination therapy). prevention of hospitalisation for heart failure dapagliflozin 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 failure (see section 5.1 pharmacodynamic properties – clinical efficacy and safety). prevention of new or worsening nephropathy dapagliflozin 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 (see section 5.1 pharmacodynamic properties – clinical efficacy and safety).

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع ادوية شاوي و رشيدات و مسنات - shawi & rushedat drug store - dapagliflozin as propanediol monohydrate 10 mg - as propanediol monohydrate 10 mg

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع ادوية شاوي و رشيدات و مسنات - shawi & rushedat drug store - dapagliflozin as propanediol monohydrate 5 mg - as propanediol monohydrate 5 mg

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

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

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

astrazeneca uk ltd - dapagliflozin propanediol monohydrate - tablet - 5mg

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

astrazeneca uk ltd - dapagliflozin propanediol monohydrate - tablet - 10mg