| 商品名称 | Provenge |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Prostatic Neoplasms |
| 通用名/非专利名称 | autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T) |
| 活性成分 | autologous peripheral-blood mononuclear cells including a minimum of 50 million autologous CD54+ cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor |
| 产品号 | EMEA/H/C/002513 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | L03AX17 |
| 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 | No |
| 上市许可日期 | 2013/09/06 |
| 上市许可开发者/申请人/持有人 | Dendreon UK Ltd |
| 人用药物治疗学分组 | Other immunostimulants |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2015/05/06 |
| 修订号 | 1 |
| 治疗适应症 | Provenge is indicated for treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate-resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2015/05/06 |
| 最后更新日期 | 2015/05/19 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/provenge-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/provenge |