| 商品名称 | Tookad |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Prostatic Neoplasms |
| 通用名/非专利名称 | padeliporfin |
| 活性成分 | padeliporfin di-potassium |
| 产品号 | EMEA/H/C/004182 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01XD07 |
| 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 | 2017/11/10 |
| 上市许可开发者/申请人/持有人 | STEBA Biotech S.A |
| 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 | 2017/09/14 |
| 欧盟委员会决定日期 | 2022/12/07 |
| 修订号 | 6 |
| 治疗适应症 | Tookad is indicated as monotherapy for adult patients with previously untreated, unilateral, low risk, adenocarcinoma of the prostate with a life expectancy ? 10 years and: Clinical stage T1c or T2a; Gleason Score ? 6, based on high-resolution biopsy strategies; PSA ? 10 ng/mL; 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ? 50 % cancer involvement in any one core or a PSA density ? 0.15 ng/mL/cm³. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/09/21 |
| 最后更新日期 | 2022/12/07 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/tookad-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tookad |