| 商品名称 | Insulin Human Winthrop |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Diabetes Mellitus |
| 通用名/非专利名称 | insulin human |
| 活性成分 | Insulin human |
| 产品号 | EMEA/H/C/000761 |
| 患者安全信息 | no |
| 授权状态 | Withdrawn |
| ATC编码 | A10AB01 |
| 是否额外监管 | no |
| 是否仿制药 | 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 |
| 批准上市日期 | 2007/01/17 |
| 上市许可持有人/公司名称 | sanofi-aventis Deutschland GmbH |
| 人用药物治疗分组 | Drugs used in diabetes |
| 决定日期 | 2016/04/28 |
| 修订号 | 15 |
| 适应症 | Diabetes mellitus where treatment with insulin is required. Insulin Human Winthrop Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and postoperative stabilisation in patients with diabetes mellitus. |
| 首次发布日期 | 2016/04/28 |
| 修订日期 | 2018/04/30 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/insulin-human-winthrop-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-human-winthrop |