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法规知识库 · EMA 集中审评

Celdoxome pegylated liposomal

doxorubicin hydrochloride · EMEA/H/C/005330 · 已失效

获批上市许可

2022-09-15

欧委会决定日

2024-03-21

持有人 / 申请人

Baxter Holding B.V.

终止日期字段

2025-09-22

从产品到官方文件

文件记录

7

官方索引 7

EPAR / 审评

5

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:L01DB01

治疗领域:Breast Neoplasms;Ovarian Neoplasms;Multiple Myeloma;Sarcoma, Kaposi

药理分类:Antineoplastic agents

修订号:3 · 最新影响 PI 的程序:H/C/005330/T/0004

适应症(原文):Celdoxome pegylated liposomal is indicated in adults: as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. Celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

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. 2025-09-22 · 上市许可终止(撤市/失效/撤销等)

    Lapsed

  2. 2024-03-21 · 欧委会决定

  3. 2022-09-15 · 获批上市许可

  4. 2022-07-21 · 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 5产品信息 2其他 0

EPAR / 审评资料

  • Celdoxome pegylated liposomal : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2025-11-27

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  • Celdoxome pegylated liposomal-H-C-PSUSA-00001172-202211 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2025-11-27 · EMA/400469/2023

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  • Celdoxome pegylated liposomal : EPAR - Medicine Overview

    overview · 2025-11-27 · EMA/695741/2022

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  • Celdoxome pegylated liposomal : EPAR - Risk management plan summary

    rmp-summary · 2025-11-27

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  • Celdoxome pegylated liposomal : EPAR - Public Assessment Report

    assessment-report · 2025-11-27 · EMA/685994/2022

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产品信息

  • Celdoxome pegylated liposomal : EPAR - Product Information

    product-information · 2025-11-27

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  • Celdoxome pegylated liposomal : EPAR - All authorised presentations

    all-authorised-presentations · 2025-11-27

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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。