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法规知识库 · EMA 集中审评

Lenalidomide Krka d.d.

lenalidomide hydrochloride hydrate · EMEA/H/C/005729 · 已撤市

仿制药

获批上市许可

2021-02-11

欧委会决定日

2021-12-13

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

7

官方索引 7

EPAR / 审评

5

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:L04AX04

治疗领域:Multiple Myeloma;Lymphoma, Follicular;Myelodysplastic Syndromes

药理分类:Immunosuppressants

修订号:2 · 最新影响 PI 的程序:IB/0003

适应症(原文):Multiple myeloma Lenalidomide 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 syndromes Lenalidomide 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 lymphoma Lenalidomide 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).

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。

  1. 2021-12-13 · 欧委会决定

  2. 2021-02-11 · 获批上市许可

  3. 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 5产品信息 2其他 0

EPAR / 审评资料

  • Lenalidomide Krka d.d. : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2023-07-10

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  • Lenalidomide Krka d.d. : EPAR - Conditions imposed on member states for safe and effective use

    conditions-member-states · 2023-07-10

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  • Lenalidomide Krka d.d. : EPAR - Public assessment report

    assessment-report · 2023-07-10 · EMA/CHMP/3809/2021

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  • Lenalidomide Krka d.d. : EPAR - Medicine overview

    overview · 2023-07-10 · EMA/11795/2021

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  • Lenalidomide Krka d.d. : EPAR - Risk-management-plan summary

    rmp-summary · 2023-07-10

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产品信息

  • Lenalidomide Krka d.d. : EPAR - Product information

    product-information · 2023-07-10

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  • Lenalidomide Krka d.d. : EPAR - All authorised presentations

    all-authorised-presentations · 2023-07-10

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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。