法规知识库 · EMA 集中审评
Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto)
lenalidomide hydrochloride monohydrate · EMEA/H/C/005348 · 已授权
获批上市许可
2021-02-11
欧委会决定日
2026-03-12
持有人 / 申请人
KRKA tovarna zdravil d.d. Novo mesto
终止日期字段
无
从产品到官方文件
文件记录
8
官方索引 8
EPAR / 审评
6
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:L04AX04
治疗领域:Multiple Myeloma;Myelodysplastic Syndromes;Lymphoma, Follicular;Lymphoma, Mantle-Cell
药理分类:Immunosuppressants
修订号:7 · 最新影响 PI 的程序:VR/0000310403
适应症(原文):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).
关键日期时间轴
来自 EMA medicines JSON 日期字段;缺失字段不展示,不补推结论。
2026-03-12 · 欧委会决定
2021-02-11 · 获批上市许可
2020-12-10 · CHMP 意见通过
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url;本站不下载或镜像 PDF。
EPAR / 审评资料
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Lenalidomide Krka : EPAR - Procedural steps taken and scientific information after the authorisation
procedural-steps-after · 2026-03-12
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Lenalidomide Krka : EPAR - Risk management plan
rmp-summary · 2026-03-12
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Lenalidomide Krka : EPAR - Procedural steps taken and scientific information after the authorisation (archive)
procedural-steps-after · 2026-01-07
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Lenalidomide Krka : EPAR - Medicine overview
overview · 2021-09-01 · EMA/422762/2021
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Lenalidomide Krka : EPAR - Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the member states
conditions-member-states · 2021-09-01
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Lenalidomide Krka d.d. Novo mesto : EPAR - Public assessment report
assessment-report · 2021-02-18 · EMA/CHMP/3824/2021
数据来自 EMA 官方 JSON;最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。