Ausztrália - angol - 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).

Új-Zéland - angol - 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).

Új-Zéland - angol - 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).

Új-Zéland - angol - 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).

Izrael - angol - 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.

Izrael - angol - 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

Izrael - angol - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin propanediol; metformin hydrochloride - tablets extended release - metformin hydrochloride 502.61 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.

Izrael - angol - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin propanediol; metformin hydrochloride - tablets extended release - metformin hydrochloride 502.61 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.

Ausztrália - angol - 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.

Izrael - angol - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin propanediol; metformin hydrochloride - tablets extended release - metformin hydrochloride 1005.04 mg; dapagliflozin propanediol 6.150 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.