Uganda - English - National Drug Authority

cipla ltd. - dapagliflozin propanediol - oral solid ordinary film-coated tablets - 10mg

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.

Kenya - English - Pharmacy and Poisons Board

m/s. innocia lifesciences pvt. ltd. block a, no.12, balaji nagar, ambattur, chennai – - dapagliflozin propanediol monohydrate & metformin… - tablet - dapagliflozin propanediol monohydrate equivalent… - metformin and dapagliflozin

Kenya - English - Pharmacy and Poisons Board

m/s. innocia lifesciences pvt. ltd. m/s. innocia lifesciences pvt. ltd. 12 balaji - dapagliflozin propanediol monohydrate,… - film-coated tablet - dapagliflozin propanediol monohydrate equivalent… - metformin and dapagliflozin

Kenya - English - Pharmacy and Poisons Board

m/s. innocia lifesciences pvt. ltd. m/s. innocia lifesciences pvt. ltd. 12 balaji - dapagliflozin propanediol monohydrate,… - film-coated tablet - dapagliflozin propanediol monohydrate equivalent… - metformin and dapagliflozin

Kenya - English - Pharmacy and Poisons Board

ccl pharmaceuticals (pvt.) ltd. 65-industrial estate, kot lakhpat, lahore-54770, - dapagliflozin (propanediol monohydrate) &… - tablet - dapagliflozin (propanediol monohydrate) 5mg& … - metformin and dapagliflozin

Kenya - English - Pharmacy and Poisons Board

ccl pharmaceuticals (pvt.) ltd. 65-industrial estate, kot lakhpat, lahore-54770, - dapagliflozin (propanediol monohydrate) &… - tablet - dapagliflozin (propanediol monohydrate) 5mg &… - metformin and dapagliflozin

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - dapagliflozin 10mg - film coated tablet - 10 mg - active: dapagliflozin 10mg excipient: colloidal silicon dioxide crospovidone lactose microcrystalline cellulose opadry yellow 85f32782 sodium laurilsulfate sodium stearyl fumarate - type 2 diabetes mellitus glycaemic control 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. · 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 clinical efficacy and safety, and 4.4 special warnings and precautions for use for available data on different add-on combination therapies). prevention of hospitalisation for heart failure 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 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).

European Union - English - EMA (European Medicines Agency)

astra zeneca ab - saxagliptin, dapagliflozin propanediol monohydrate - diabetes mellitus, type 2; diabetes mellitus; nutritional and metabolic diseases; metabolic diseases; glucose metabolism disorders - drugs used in diabetes - qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin and/or sulphonylurea (su) and one of the monocomponents of qtern do not provide adequate glycaemic control,when already being treated with the free combination of dapagliflozin and saxagliptin.(see sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.)