Canada - English - Health Canada

nora pharma inc - dapagliflozin - tablet - 5mg - dapagliflozin 5mg

Canada - English - Health Canada

nora pharma inc - dapagliflozin - tablet - 10mg - dapagliflozin 10mg

Canada - English - Health Canada

taro pharmaceuticals inc - dapagliflozin - tablet - 5mg - dapagliflozin 5mg

Canada - English - Health Canada

taro pharmaceuticals inc - dapagliflozin - tablet - 10mg - dapagliflozin 10mg

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.

Canada - English - Health Canada

astrazeneca canada inc - saxagliptin (saxagliptin hydrochloride); dapagliflozin (dapagliflozin propanediol monohydrate) - tablet - 5mg; 5mg - saxagliptin (saxagliptin hydrochloride) 5mg; dapagliflozin (dapagliflozin propanediol monohydrate) 5mg - dipeptidyl peptidase-4 (dpp-4) inhibitors

Canada - English - Health Canada

astrazeneca canada inc - saxagliptin (saxagliptin hydrochloride); dapagliflozin (dapagliflozin propanediol monohydrate) - tablet - 5mg; 10mg - saxagliptin (saxagliptin hydrochloride) 5mg; dapagliflozin (dapagliflozin propanediol monohydrate) 10mg - dipeptidyl peptidase-4 (dpp-4) inhibitors

Canada - English - Health Canada

teva canada limited - dapagliflozin - tablet - 5mg - dapagliflozin 5mg

Canada - English - Health Canada

teva canada limited - dapagliflozin - tablet - 10mg - dapagliflozin 10mg