| 商品名称 | Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto) |
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| 适用类别 | Human |
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| 治疗领域 | Multiple Myeloma;Myelodysplastic Syndromes;Lymphoma, Follicular;Lymphoma, Mantle-Cell |
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| 通用名/非专利名称 | lenalidomide |
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| 活性成分 | lenalidomide hydrochloride monohydrate |
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| 产品号 | EMEA/H/C/005348 |
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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 | L04AX04 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | Yes |
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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 | 2021/02/11 |
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| 上市许可开发者/申请人/持有人 | Krka, d.d., Novo mesto |
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| 人用药物治疗学分组 | Immunosuppressants |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2020/12/10 |
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| 欧盟委员会决定日期 | 2024/07/02 |
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| 修订号 | 5 |
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| 治疗适应症 | Multiple myelomaLenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromesLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.Mantle cell lymphomaLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1). Follicular lymphomaLenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a). Multiple myelomaLenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromesLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. Mantle cell lymphomaLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1). Follicular lymphomaLenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a). |
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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 | 2021/02/18 |
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| 最后更新日期 | 2024/07/26 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/lenalidomide-krka-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/lenalidomide-krka |
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