法规知识库 · EMA 集中审评
Busilvex
busulfan · EMEA/H/C/000472 · 已撤市
获批上市许可
2003-07-09
欧委会决定日
2022-02-01
持有人 / 申请人
Pierre Fabre Medicament
终止日期字段
无
从产品到官方文件
文件记录
11
官方索引 11
EPAR / 审评
9
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01AB01
治疗领域：Hematopoietic Stem Cell Transplantation
药理分类：Antineoplastic agents
修订号：19 · 最新影响 PI 的程序：IAIN/0035/G
适应症（原文）：Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option. Busilvex following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen. Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
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。
2022-02-01 · 欧委会决定
2003-07-09 · 获批上市许可
2003-03-19 · 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
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Busilvex-H-C-PSUSA-00000464-201607 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-08-04 · EMA/566488/2017
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Busilvex-H-C-472-II-019 : EPAR - Assessment Report - Variation
variation-report · 2023-08-04 · EMA/550530/2014
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Busilvex-H-C-PSUSA-0464 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-08-04
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Busilvex-H-C-472-A20-13 : EPAR - Assessment Report - Article 20
variation-report · 2023-08-04 · EMA/303399/2012
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Busilvex : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2023-08-04
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Busilvex : EPAR - Summary for the public
overview · 2023-08-04 · EMA/500878/2014
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Busilvex-H-C-472-II-04 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2023-08-04
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Busilvex : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2023-08-04
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Busilvex : EPAR - Scientific Discussion
scientific-discussion · 2023-08-04
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。