Kenya - English - Pharmacy and Poisons Board

dawa limited plot no 7879/8,baba dogo rd,ruaraka,p.o box - dapagliflozin propanediol monohydrate - film-coated tablet - each film coated tablet contains: dapagliflozin… - dapagliflozin

Kenya - English - Pharmacy and Poisons Board

liptis for pharmaceutical and medical products… plot no. b/2, 6th industrial zone, 6th of october - dapagliflozin propanediol monohydrate - film-coated tablet - each film coated tablet contains: dapagliflozin… - dapagliflozin

Kenya - English - Pharmacy and Poisons Board

ajanta pharma limited ajanta house, charkop, kandivli (west), mumbai- - dapagliflozin ih - film-coated tablet - each film coated contains dapagliflozin 10mg - dapagliflozin

Kenya - English - Pharmacy and Poisons Board

ajanta pharma limited ajanta house, charkop, kandivli (west), mumbai- - dapagliflozin ih - film-coated tablet - each film coated tablet contains dapagliflozin 5mg - dapagliflozin

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).

Kenya - English - Pharmacy and Poisons Board

medcure healthcare limited. p.o box 14609-00400 nairobi-kenya. - dapagliflozin propanediol monohydrate - film-coated tablet - each film coated tablets contains: dapagliflozin… - dapagliflozin

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.

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.