法规知识库 · EMA 集中审评
Velcade
bortezomib · EMEA/H/C/000539 · 已授权
获批上市许可
2004-04-26
欧委会决定日
2024-10-16
持有人 / 申请人
Janssen-Cilag International NV
终止日期字段
无
从产品到官方文件
文件记录
18
官方索引 18
EPAR / 审评
16
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：46 · 最新影响 PI 的程序：N/0103
适应症（原文）：Velcade 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. Velcade 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. Velcade 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. Velcade 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。
2024-10-16 · 欧委会决定
2004-04-26 · 获批上市许可
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
- 打开官方文件 ↗
Velcade : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2024-10-18
- 打开官方文件 ↗
Velcade-H-C-PSUSA-00000424-202004 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-03-01 · EMA/122201/2021
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Velcade : EPAR - Medicine overview
overview · 2020-06-12 · EMA/318389/2020
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Velcade : EPAR - Risk-management-plan summary
rmp-summary · 2020-04-08
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Velcade-H-C-PSUSA-00000424-201804 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-03-28 · EMA/169116/2019
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Velcade-H-C-539-II-0059 : EPAR - Assessment Report - Variation
variation-report · 2016-12-07 · EMA/416707/2013
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Velcade-H-C-539-II-0079 : EPAR - Assessment Report - Variation
variation-report · 2016-06-20 · EMA/419238/2016
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Velcade-H-C-PSUSA-00000424-201504 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-02-10 · EMA/747320/2015
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Velcade-H-C-539-II-0072 : EPAR - Assessment Report - Variation
variation-report · 2015-03-27 · EMA/74029/2015
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Velcade-H-C-539-II-0063-G : EPAR - Assessment Report - Variation
variation-report · 2014-02-19 · EMA/CHMP/775037/2013
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Velcade-H-C-539-X-0047 : EPAR - Assessment Report - Extension
variation-report · 2012-10-17 · EMA/432973/2012
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Velcade-H-C-539-A20-0056 : EPAR - Assessment Report - Article 20
variation-report · 2012-08-23 · EMA/303400/2012
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Velcade-H-C-539-II-0028 : EPAR - Assessment Report - Variation
variation-report · 2008-09-10
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Velcade-H-C-539-II-0005 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2006-08-15
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Velcade : EPAR - Scientific Discussion
scientific-discussion · 2006-08-15
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Velcade : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-08-15
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。