| 商品名称 | Palbociclib Viatris |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Breast Neoplasms |
| 通用名/非专利名称 | palbociclib |
| 活性成分 | Palbociclib |
| 产品号 | EMEA/H/C/006624 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01EF01 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | Yes |
| 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 | 2026/06/19 |
| 上市许可开发者/申请人/持有人 | Viatris Limited |
| 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 | 2026/04/23 |
| 修订号 | |
| 治疗适应症 | Palbociclib Viatris is indicated for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative locally advanced or metastatic breast cancer. in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1). In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone‑releasing hormone (LHRH) agonist. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2026/04/24 |
| 最后更新日期 | 2026/06/23 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/palbociclib-viatris-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/palbociclib-viatris |