| 商品名称 | Lenalidomide Krka d.d. |
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| 适用类别 | Human |
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| 治疗领域 | Multiple Myeloma; Lymphoma, Follicular; Myelodysplastic Syndromes |
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| 通用名/非专利名称 | lenalidomide |
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| 活性成分 | lenalidomide hydrochloride hydrate |
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| 产品号 | EMEA/H/C/005729 |
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| 患者安全信息 | no |
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| 授权状态 | Withdrawn |
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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 | 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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| 批准上市日期 | 2021/02/11 |
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| 上市许可持有人/公司名称 | Krka, d.d., Novo mesto |
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| 人用药物治疗分组 | Immunosuppressants |
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| 审评意见发布日期 | 2020/12/10 |
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| 决定日期 | 2021/12/13 |
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| 修订号 | 2 |
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| 适应症 | Multiple myelomaLenalidomide Krka d.d. 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 d.d. 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 d.d. 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 d.d. 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.Follicular lymphomaLenalidomide Krka d.d. 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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| 首次发布日期 | 2021/02/18 |
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| 修订日期 | 2023/07/10 |
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| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/lenalidomide-krka-dd-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-dd |
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