法规知识库 · EMA 集中审评
Vidaza
azacitidine · EMEA/H/C/000978 · 已授权
获批上市许可
2008-12-17
欧委会决定日
2024-11-01
持有人 / 申请人
Bristol-Myers Squibb Pharma EEIG
终止日期字段
无
从产品到官方文件
文件记录
14
官方索引 14
EPAR / 审评
12
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01BC07
治疗领域：Myelodysplastic Syndromes;Leukemia, Myelomonocytic, Chronic;Leukemia, Myeloid, Acute
药理分类：Antineoplastic agents
修订号：28 · 最新影响 PI 的程序：N/0062
适应症（原文）：Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate 2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) with 10 29 % marrow blasts without myeloproliferative disorder, acute myeloid leukaemia (AML) with 20 30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification. Vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for HSCT with AML with >30% marrow blasts according to the WHO classification.
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。
2024-11-01 · 欧委会决定
2008-12-17 · 获批上市许可
2008-10-23 · 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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Vidaza : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2024-11-05
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Vidaza : EPAR - Risk-management-plan
rmp · 2023-06-15
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Vidaza-H-C-PSUSA-00000274-202105 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-05-03 · EMA/244434/2022
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Vidaza-H-C-978-P46-035 : EPAR - Assessment report
variation-report · 2021-02-16 · EMA/295254/2020
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Vidaza-H-C-978-P46-034.1 : EPAR - Assessment Report
variation-report · 2020-09-15 · EMA/372102/2020
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Vidaza-H-C-PSUSA-00000274-201805 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-04-11 · EMA/169014/2019
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Vidaza : EPAR - Summary for the public
overview · 2016-08-17
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Vidaza : EPAR - Scientific Conclusion
scientific-conclusion · 2016-04-14 · EMA/152711/2016
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Vidaza-H-C-978-II-0030 : EPAR - Assessment Report - Variation
variation-report · 2015-12-16 · EMA/757391/2015
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Vidaza-H-C-978-PSUV-0029 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-03-25 · EMA/CHMP/34968/2015
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Vidaza-H-C-978-A20-0017: EPAR - Assessment Report - Article 20
variation-report · 2012-07-24 · EMA/303405/2012
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Vidaza : EPAR - Public assessment report
assessment-report · 2009-01-23
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。