| 商品名称 | Lextemy |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms |
| 通用名/非专利名称 | bevacizumab |
| 活性成分 | bevacizumab |
| 产品号 | EMEA/H/C/005611 |
| 患者安全信息 | no |
| 授权状态 | Withdrawn |
| ATC编码 | L01XC07 |
| 是否额外监管 | no |
| 是否仿制药 | no |
| 是否生物类似药 | yes |
| 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 |
| 上市许可持有人/公司名称 | Mylan IRE Healthcare Limited |
| 人用药物治疗分组 | Antineoplastic agents |
| 审评意见发布日期 | 2021/02/25 |
| 修订号 | |
| 适应症 | Treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix. |
| 首次发布日期 | 2021/02/24 |
| 产品信息 | |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/lextemy-0 |