| 商品名称 | Tyverb |
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| 适用类别 | Human |
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| 治疗领域 | Breast Neoplasms |
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| 通用名/非专利名称 | lapatinib |
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| 活性成分 | lapatinib |
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| 产品号 | EMEA/H/C/000795 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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| ATC编码 | L01EH01 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | No |
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| 是否生物类似药 | No |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | No |
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| 是否罕用药 | No |
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| 上市许可日期 | 2008/06/10 |
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| 上市许可开发者/申请人/持有人 | Novartis Europharm Limited |
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| 人用药物治疗学分组 | Protein kinase inhibitors |
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| 兽用药物治疗学分组 | |
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| 欧盟委员会决定日期 | 2025/08/21 |
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| 修订号 | 38 |
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| 治疗适应症 | Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2): in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting; in combination with trastuzumab for patients with hormone-receptor-negative metastatic disease that has progressed on prior trastuzumab therapy or therapies in combination with chemotherapy; in combination with an aromatase inhibitor for post-menopausal women with hormone-receptor-positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study had not previously been treated with trastuzumab or an aromatase inhibitor. No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population. |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2018/07/30 |
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| 最后更新日期 | 2025/08/25 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/tyverb-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tyverb |
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