法规知识库 · EMA 集中审评
Darzalex
daratumumab · EMEA/H/C/004077 · 已授权
获批上市许可
2016-05-20
欧委会决定日
2026-06-11
持有人 / 申请人
未知
终止日期字段
无
从产品到官方文件
文件记录
22
官方索引 22
EPAR / 审评
19
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC:L01FC01
治疗领域:Multiple Myeloma
药理分类:Antineoplastic agents;monoclonal antibodies and antibody drug conjugates
修订号:30 · 最新影响 PI 的程序:VR/0000334930
适应症(原文):Multiple Myeloma Darzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma. in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5.1). in as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. Smouldering multiple myeloma Darzalex as monotherapy is indicated for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma. Light chain (AL) amyloidosis Darzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis. Darzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
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。
2026-06-11 · 欧委会决定
2016-05-20 · 获批上市许可
2016-03-31 · 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 ↗
Darzalex : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-07-21
- 打开官方文件 ↗
Darzalex : EPAR - Risk management plan
rmp · 2026-07-21
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Darzalex-H-C-004077-II-0077 : EPAR - Assessment report - Variation
variation-report · 2025-08-29 · EMA/CHMP/144719/2025
- 打开官方文件 ↗
Darzalex : Orphan Maintenance Assessment Report (post authorisation)
orphan-maintenance-report-post · 2025-08-29 · EMA/OD/0000240835
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Darzalex : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-08-29
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Darzalex : EPAR - Medicine overview
overview · 2025-08-29 · EMA/86998/2025
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Darzalex-H-C-004077-II-0076 : EPAR - Assessment report - Variation
variation-report · 2025-04-10 · EMA/CHMP/96363/2025
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Darzalex-H-C-004077-II-0030 : EPAR - Assessment report - Variation
variation-report · 2025-03-20 · EMA/CHMP/22749/2020
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Darzalex-H-C-004077-II-0072 : EPAR - Assessment report - Variation
variation-report · 2025-01-21 · EMA/CHMP/494023/2024
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Darzalex-H-C-4077-II-0043 : EPAR - Assessment report - Variation
variation-report · 2021-08-03 · EMA/433036/2021
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Darzalex-H-C-4077-II-0044 : EPAR - Assessment report - Variation
variation-report · 2021-08-03 · EMA/CHMP/266131/2021
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Darzalex : Orphan maintenance assessment report (post-authorisation)
orphan-maintenance-report-post · 2021-08-03 · EMADOC-1700519818-685605
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Darzalex-H-C-4077-II-0029 : EPAR - Assessment Report - Variation
variation-report · 2020-11-20 · EMA/CHMP/622108/2019
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Darzalex-H-C-4077-X-0032 : EPAR - Assessment Report - Extension
variation-report · 2020-07-10 · EMA/CHMP/273138/2020
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Darzalex-H-C-4077-II-0030 : EPAR - Assessment Report - Variation
variation-report · 2020-01-23 · EMA/CHMP/22749/2020
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Darzalex : Orphan maintenance assessment report (post-authorisation)
orphan-maintenance-report-post · 2020-01-23 · EMA/OD/0000010020 Corr. 1
- 打开官方文件 ↗
Darzalex-H-C-4077-II-0011 : EPAR - Assessment Report - Variation
variation-report · 2018-09-21 · EMA/CHMP/599644/2018
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Darzalex-H-C-4077-II-0002 : EPAR - Assessment report - Variation
variation-report · 2017-06-02 · EMA/193295/2017
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Darzalex : EPAR - Public assessment report
assessment-report · 2016-05-27 · EMA/278085/2016
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。