| 商品名称 | Perjeta |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Breast Neoplasms |
| 通用名/非专利名称 | pertuzumab |
| 活性成分 | pertuzumab |
| 产品号 | EMEA/H/C/002547 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01FD02 |
| 是否额外监管 | No |
| 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 | 2013/03/04 |
| 上市许可开发者/申请人/持有人 | Roche Registration GmbH |
| 人用药物治疗学分组 | Antineoplastic agents;monoclonal antibodies and antibody drug conjugates |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2025/09/04 |
| 修订号 | 26 |
| 治疗适应症 | Metastatic Breast Cancer: Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. Neoadjuvant Treatment of Breast Cancer: Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/05/31 |
| 最后更新日期 | 2025/10/30 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/perjeta |