| 商品名称 | Pemetrexed Krka |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Carcinoma, Non-Small-Cell Lung;Mesothelioma |
| 通用名/非专利名称 | pemetrexed |
| 活性成分 | pemetrexed disodium |
| 产品号 | EMEA/H/C/003958 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | L01BA04 |
| 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 | 2018/05/22 |
| 上市许可开发者/申请人/持有人 | KRKA d.d. |
| 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 | 2018/03/22 |
| 欧盟委员会决定日期 | 2023/02/15 |
| 修订号 | 6 |
| 治疗适应症 | Malignant pleural mesothelioma Pemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Krka in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Krka is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Krka is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/05/22 |
| 最后更新日期 | 2024/07/30 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/pemetrexed-krka-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/pemetrexed-krka |