法规知识库 · EMA 集中审评
Sarclisa
Isatuximab · EMEA/H/C/004977 · 已授权
获批上市许可
2020-05-30
欧委会决定日
2026-07-07
持有人 / 申请人
Sanofi Winthrop Industrie
终止日期字段
无
从产品到官方文件
文件记录
16
官方索引 16
EPAR / 审评
14
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01XC38
治疗领域：Multiple Myeloma
药理分类：Antineoplastic agents
修订号：15 · 最新影响 PI 的程序：VR/0000355488
适应症（原文）：Sarclisa is indicated: In combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. In combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. In combination with bortezomib, lenalidomide, and dexamethasone, 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 induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
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。
2026-07-07 · 欧委会决定
2020-05-30 · 获批上市许可
2020-03-26 · 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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Sarclisa : EPAR - Procedural steps taken and scientific information after authorisation
variation-report · 2026-07-07
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Sarclisa-X-0000281242 : EPAR - Assessment report - Extension
variation-report · 2026-06-09 · EMADOC-1700519818-3141936
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Sarclisa : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-06-09
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Sarclisa : EPAR - Medicine overview
overview · 2026-06-09 · EMADOC-1829012207-48042
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Sarclisa : EPAR - Risk management plan
rmp · 2026-06-09
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Sarclisa-H-C-004977-II-0035 : EPAR - Assessment report - Variation
variation-report · 2025-08-28 · EMA/CHMP/186921/2025
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Sarclisa-H-C-004977-II-0030 : EPAR - Assessment report - Variation
variation-report · 2025-03-12 · EMA/555367/2024
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Sarclisa : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2024-05-28 · EMA/CHMP/137460/2024
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Sarclisa-H-C-PSUSA-00010851-202203 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-01-18 · EMA/29807/2023
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Sarclisa-H-C-PSUSA-00010851-202103 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-10-03 · EMA/798010/2022
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Sarclisa-H-C-PSUSA-00010851-202103 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-02-04 · EMA/73528/2022
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Sarclisa-H-C-004977-II-0003 : EPAR - Assessment report - Variation
variation-report · 2021-05-17 · EMA/CHMP/186236/2021
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Sarclisa : EPAR - Public assessment report
assessment-report · 2020-06-12 · EMA/CHMP/200978/2020
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Sarclisa : Orphan designation withdrawal assessment report (initial authorisation)
orphan-maintenance-report · 2020-06-12 · EMADOC-1700519818-465242
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。