法规知识库 · EMA 集中审评
Lumark
lutetium (177Lu) chloride · EMEA/H/C/002749 · 已撤市
获批上市许可
2015-06-18
欧委会决定日
2020-09-17
持有人 / 申请人
I.D.B. Radiopharmacy B.V.
终止日期字段
2026-01-16
从产品到官方文件
文件记录
12
官方索引 12
EPAR / 审评
10
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：V10
治疗领域：Radionuclide Imaging
药理分类：Therapeutic radiopharmaceuticals
修订号：9 · 最新影响 PI 的程序：PSUSA/00010391/201912
适应症（原文）：Lumark is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.
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。
2026-01-16 · 上市许可终止（撤市/失效/撤销等）
Withdrawn
2020-09-17 · 欧委会决定
2015-06-18 · 获批上市许可
2015-04-22 · 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
- 打开官方文件 ↗
Lumark-H-C-PSUSA-00010391-201912 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-02-11 · EMA/509367/2020
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Lumark-H-C-PSUSA-00010391-201812 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-02-11 · EMA/449645/2019
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Lumark-H-C-PSUSA-00010391-201806 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-02-11 · EMA/199298/2019
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Lumark-H-C-PSUSA-00010391-201712 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-02-11 · EMA/895480/2018
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Lumark-H-C-PSUSA-00010391-201706 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-02-11 · EMA/207706/2018
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Lumark-H-C-PSUSA-00010391-201612 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-02-11 · EMA/686367/2017
- 打开官方文件 ↗
Lumark : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-02-11
- 打开官方文件 ↗
Lumark : EPAR - Risk-management-plan summary
rmp-summary · 2026-02-11
- 打开官方文件 ↗
Lumark : EPAR - Public assessment report
assessment-report · 2026-02-11 · EMA/427491/2015
- 打开官方文件 ↗
Lumark : EPAR - Medicine overview
overview · 2026-02-11 · EMA/285451/2015
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。