| 商品名称 | Kepivance |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Mucositis |
| 通用名/非专利名称 | palifermin |
| 活性成分 | palifermin |
| 产品号 | EMEA/H/C/000609 |
| 患者安全信息 | no |
| 授权状态 | Withdrawn |
| ATC编码 | V03AF08 |
| 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 | 2005/10/25 |
| 上市许可持有人/公司名称 | Swedish Orphan Biovitrum AB (publ) |
| 人用药物治疗分组 | All other therapeutic products |
| 决定日期 | 2016/04/01 |
| 修订号 | 19 |
| 适应症 | Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous-haematopoietic-stem-cell support. |
| 首次发布日期 | 2016/04/01 |
| 修订日期 | 2016/04/08 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/kepivance-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/kepivance |