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法规知识库 · EMA 集中审评

Bortezomib Fresenius Kabi

bortezomib · EMEA/H/C/005074 · 已授权

仿制药

获批上市许可

2019-11-14

欧委会决定日

2025-02-13

持有人 / 申请人

Fresenius Kabi Deutschland GmbH

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:L01XG01

治疗领域:Multiple Myeloma

药理分类:Antineoplastic agents

修订号:7 · 最新影响 PI 的程序:VR/0000244627

适应症(原文):Bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

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. 2025-02-13 · 欧委会决定

  2. 2019-11-14 · 获批上市许可

  3. 2019-09-19 · 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 6产品信息 2其他 0

EPAR / 审评资料

  • Bortezomib Fresenius Kabi : EPAR - Procedural steps taken and scientific information after the authorisation

    procedural-steps-after · 2025-02-13

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  • Bortezomib Fresenius Kabi : EPAR - Procedural steps taken and scientific information after the authorisation (archive)

    procedural-steps-after · 2025-02-13

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  • Bortezomib Fresenius Kabi-H-C-PSUSA-00000424-202004 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2021-03-24 · EMA/122201/2021

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  • Bortezomib Fresenius Kabi : EPAR - Medicine overview

    overview · 2019-11-25 · EMA/519551/2019

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  • Bortezomib Fresenius Kabi : EPAR - Public assessment report

    assessment-report · 2019-11-25 · EMA/CHMP/552819/2019

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  • Bortezomib Fresenius Kabi : EPAR - Risk-management-plan summary

    rmp-summary · 2019-11-25

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产品信息

  • Bortezomib Fresenius Kabi : EPAR - Product information

    product-information · 2025-02-13

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  • Bortezomib Fresenius Kabi : EPAR - All authorised presentations

    all-authorised-presentations · 2021-01-18

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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。