| Product No | EMEA/H/C/006006 |
|---|---|
| Brand Name | Dapagliflozin Viatris |
| Nonproprietary Name | dapagliflozin |
| API | dapagliflozin |
| ATC Code | A10BK01 |
| Indications | 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 and 5.1.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. |
| Orphan Drug | no |
| Generics | yes |
| Marketing Authorization Holder | Viatris Limited |
| Status | Authorised(授权) |
| Authorization Date | 2023-03-24 |
| Version | 0 |
| Condition Approval | no |
| Exceptions | no |
| Biosimilar | no |
| Details | 查看 (公众评估报告、授权细节、产品规格/剂型、标签、历史评估信息) |
Extended Information