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法规知识库 · EMA 集中审评

Darzalex

daratumumab · EMEA/H/C/004077 · 已授权

加速评价

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。

  1. 2026-06-11 · 欧委会决定

  2. 2016-05-20 · 获批上市许可

  3. 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 19产品信息 3其他 0

EPAR / 审评资料

  • Darzalex : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2026-07-21

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  • 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

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  • 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

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  • 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

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产品信息

  • Darzalex : EPAR - Product Information

    product-information · 2026-07-21

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  • Darzalex : EPAR – Product information - tracked changes

    product-information-tracked-changes · 2025-10-27

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  • Darzalex : EPAR - All Authorised presentations

    all-authorised-presentations · 2020-07-10

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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。