跳到正文

法规知识库 · EMA 集中审评

Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)

lenalidomide hydrochloride monohydrate · EMEA/H/C/005734 · 已授权

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

药理分类:Immunosuppressants

修订号:3 · 最新影响 PI 的程序:IB/0004

适应症(原文):Multiple myelomaLenalidomide krka d.d. Novo mesto 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. Novo mesto 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. Novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Follicular lymphomaLenalidomide krka d.d. Novo mesto 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 d.d. Novo mesto 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. Novo mesto 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. Novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Follicular lymphomaLenalidomide krka d.d. Novo mesto 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. Novo mesto : EPAR - Procedural steps taken and scientific information after the authorisation

    procedural-steps-after · 2021-12-17

    打开官方文件 ↗
  • Lenalidomide krka d.d. Novo mesto : EPAR - Medicine overview

    overview · 2021-08-31 · EMA/422705/2021

    打开官方文件 ↗
  • Lenalidomide krka d.d. Novo mesto : 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 · 2021-08-31

    打开官方文件 ↗
  • Lenalidomide Krka : EPAR - Public assessment report

    assessment-report · 2021-02-18 · EMA/CHMP/3806/2021

    打开官方文件 ↗
  • Lenalidomide Krka d.d. Novo mesto : EPAR - Risk-management plan summary

    rmp-summary · 2021-02-18

    打开官方文件 ↗

产品信息

  • Lenalidomide krka d.d. Novo mesto : EPAR - Product information

    product-information · 2021-12-17

    打开官方文件 ↗
  • Lenalidomide krka d.d. Novo mesto : EPAR - All authorised presentations

    all-authorised-presentations · 2021-08-31

    打开官方文件 ↗

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。