| 商品名称 | Rybelsus |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Diabetes Mellitus, Type 2 |
| 通用名/非专利名称 | semaglutide |
| 活性成分 | semaglutide |
| 产品号 | EMEA/H/C/004953 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | A10BJ06 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | No |
| 是否生物类似药 | No |
| 是否附条件批准 | No |
| 是否特殊情形 | No |
| 是否加速审评 | No |
| 是否罕用药 | No |
| 上市许可日期 | 2020/04/03 |
| 上市许可开发者/申请人/持有人 | Novo Nordisk A/S |
| 人用药物治疗学分组 | Drugs used in diabetes |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2020/01/30 |
| 欧盟委员会决定日期 | 2025/09/25 |
| 修订号 | 15 |
| 治疗适应症 | Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in combination with other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2020/05/27 |
| 最后更新日期 | 2025/09/30 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/rybelsus-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/rybelsus |