| 商品名称 | Imbruvica |
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| 适用类别 | Human |
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| 治疗领域 | Lymphoma, Mantle-Cell;Leukemia, Lymphocytic, Chronic, B-Cell |
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| 通用名/非专利名称 | ibrutinib |
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| 活性成分 | Ibrutinib |
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| 产品号 | EMEA/H/C/003791 |
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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 | L01EL01 |
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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 | 2014/10/21 |
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| 上市许可开发者/申请人/持有人 | Janssen-Cilag International NV |
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| 人用药物治疗学分组 | Antineoplastic agents;Protein kinase inhibitors |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2014/07/25 |
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| 欧盟委员会决定日期 | 2025/09/11 |
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| 修订号 | 36 |
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| 治疗适应症 | Imbruvica in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (IMBRUVICA + R-CHOP) alternating with R-DHAP (or R-DHAOx) without Imbruvica, followed by Imbruvica monotherapy, is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplantation (ASCT).Imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory MCL.Imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).Imbruvica as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.Imbruvica as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM. |
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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 | 2018/07/29 |
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| 最后更新日期 | 2025/10/27 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/imbruvica-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/imbruvica |
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