10 mg, 1000 mg
Trade Name
Dezeroga-Met
Prolonged-release film-coated tablet
Request Type
New Registration
Drug Type
Generic(Multisource) Drug
Approval Date
SFDA Approved Use
Indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
Dapagliflozin is indicated to reduce:
• The risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. • The risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction. • The risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
Dezeroga-Met® is not recommended:
• For patients with type 1 diabetes mellitus or diabetic ketoacidosis. • Because of the metformin component, the use of Dezeroga-Met® is limited to adults with type 2 diabetes mellitus for all indications.
• For the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. Dezeroga-Met® is not expected to be effective in these populations.
Dapagliflozin is indicated to reduce:
• The risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. • The risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction. • The risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
Dezeroga-Met® is not recommended:
• For patients with type 1 diabetes mellitus or diabetic ketoacidosis. • Because of the metformin component, the use of Dezeroga-Met® is limited to adults with type 2 diabetes mellitus for all indications.
• For the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. Dezeroga-Met® is not expected to be effective in these populations.