Peru - španščina - DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)

diphasac sociedad anonima cerrada - droguerÍa - tableta recubierta - por comprimido - - metformina

Evropska unija - španščina - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drogas usadas en diabetes - type 2 diabetes mellitusdapagliflozin viatris 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 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, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 y 5. heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.

Evropska unija - španščina - EMA (European Medicines Agency)

astrazeneca ab - saxagliptin - diabetes mellitus, tipo 2 - drogas usadas en diabetes - add-on combination therapyonglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy:in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate;in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;as triple oral therapy:in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Peru - španščina - DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)

astrazeneca peru s.a. - droguerÍa - clorhidrato de metformina; dapagliflozina; - comprimido recubierto de liberacion prolongada - por tableta - - metformina y dapaglifozina

Ekvador - španščina - Agencia Nacional de Regulación, Control y Vigilancia Sanitaria

astrazeneca camcar sa panama - metformina (a) 1000 mg dapagliflozina (d) 10(f) mg - comprimido de liberaciÓn prolongada recubiertos con pelÍcula - cada tableta recubierta contiene: clorhidrato de metformina con estearato de magnesio al 0,5% (a) 1005,04 mg dapagliflozina propanodiol (d) 12,30(f) mg