| 商品名称 | Yescarta |
|---|
| 适用类别 | Human |
|---|
| 治疗领域 | Lymphoma, Follicular;Lymphoma, Large B-Cell, Diffuse |
|---|
| 通用名/非专利名称 | axicabtagene ciloleucel |
|---|
| 活性成分 | axicabtagene ciloleucel |
|---|
| 产品号 | EMEA/H/C/004480 |
|---|
| 患者安全信息 | No |
|---|
| 许可状态 | Authorised |
|---|
| ATC编码 | L01XX70 |
|---|
| 是否额外监管 | Yes |
|---|
| 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 | Yes |
|---|
| 上市许可日期 | 2018/08/23 |
|---|
| 上市许可开发者/申请人/持有人 | Kite Pharma EU B.V. |
|---|
| 人用药物治疗学分组 | Antineoplastic agents |
|---|
| 兽用药物治疗学分组 | |
|---|
| 审评意见日期 | 2018/06/28 |
|---|
| 欧盟委员会决定日期 | 2025/11/13 |
|---|
| 修订号 | 21 |
|---|
| 治疗适应症 | Yescarta is indicated for the treatment of adult patients with diffuse large B cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. Yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) DLBCL and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy. Yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (FL) after three or more lines of systemic therapy. |
|---|
| 适用物种 | |
|---|
| 兽用药物ATC编码 | |
|---|
| 首次发布日期 | 2018/08/23 |
|---|
| 最后更新日期 | 2025/12/08 |
|---|
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/yescarta-epar-product-information_en.pdf |
|---|
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/yescarta |
|---|