法规知识库 · EMA 集中审评
Zolsketil pegylated liposomal
doxorubicin hydrochloride, liposomal · EMEA/H/C/005320 · 已授权
获批上市许可
2022-05-31
欧委会决定日
2026-04-15
持有人 / 申请人
Accord Healthcare S.L.U.
终止日期字段
无
从产品到官方文件
文件记录
8
官方索引 8
EPAR / 审评
6
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:L01DB01
治疗领域:Ovarian Neoplasms;Sarcoma, Kaposi;Multiple Myeloma
药理分类:doxorubicin
修订号:5 · 最新影响 PI 的程序:VR/0000340547
适应症(原文):Zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults: • breast cancer that has spread to other parts of the body in patients at risk of heart problems. Zolsketil pegylated liposomal is used on its own for this disease; • advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working; • multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. Zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine); • Kaposi’s sarcoma in patients with AIDS who have a very damaged immune system. Kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. Zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance called Adriamycin. However, in Zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for Adriamycin.
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。
2026-04-15 · 欧委会决定
2022-05-31 · 获批上市许可
2022-03-24 · CHMP 意见通过
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Zolsketil pegylated liposomal : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-10-20
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Zolsketil pegylated liposomal : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-04-16
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Zolsketil pegylated liposomal-H-C-PSUSA-00001172-202211 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-09-05 · EMA/400469/2023
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Zolsketil pegylated liposomal : EPAR - Medicine overview
overview · 2022-06-20 · EMEA/H/C/005320
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Zolsketil pegylated liposomal : EPAR - Public Assessment Report
assessment-report · 2022-06-20 · EMA/CHMP/212114/2022
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Zolsketil pegylated liposomal : EPAR - Risk management plan summary
rmp-summary · 2022-06-20
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。