法规知识库 · EMA 集中审评
Caelyx pegylated liposomal
doxorubicin hydrochloride · EMEA/H/C/000089 · 已授权
获批上市许可
1996-06-20
欧委会决定日
2026-04-24
持有人 / 申请人
Baxter Holding B.V.
终止日期字段
无
从产品到官方文件
文件记录
15
官方索引 15
EPAR / 审评
12
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L01DB
治疗领域：Sarcoma, Kaposi;Multiple Myeloma;Ovarian Neoplasms;Breast Neoplasms
药理分类：Antineoplastic agents
修订号：40 · 最新影响 PI 的程序：VR/0000340616
适应症（原文）：Caelyx pegylated liposomal is indicated: as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk; for 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. Caelyx 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 standarddoxorubicin (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。
2026-04-24 · 欧委会决定
1996-06-20 · 获批上市许可
1996-02-15 · 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 ↗
Caelyx pegylated liposomal : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-04-24
- 打开官方文件 ↗
Caelyx pegylated liposomal : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-09-02
- 打开官方文件 ↗
Caelyx pegylated liposomal : EPAR - Risk-management-plan summary
rmp-summary · 2024-01-30
- 打开官方文件 ↗
Caelyx 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
- 打开官方文件 ↗
Caelyx pegylated liposomal : EPAR - Medicine overview
overview · 2020-04-02 · EMA/635791/2019
- 打开官方文件 ↗
Caelyx-H-C-PSUSA-00001172-201811 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-10-11 · EMA/553936/2019
- 打开官方文件 ↗
Caelyx-H-C-89-P46-0008 : EPAR - Assessment Report
variation-report · 2013-04-17 · EMA/CHMP/203219/2013
- 打开官方文件 ↗
Caelyx-H-C-89-A20-0061 : EPAR - Assessment Report – Article 20
variation-report · 2012-05-31 · EMA/303401/2012
- 打开官方文件 ↗
Caelyx-H-C-89-II-0045: EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2008-01-23 · EMEA/37144/2008
- 打开官方文件 ↗
Caelyx : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2005-10-21
- 打开官方文件 ↗
Caelyx : EPAR - Scientific Discussion
scientific-discussion · 2005-10-21
- 打开官方文件 ↗
Caelyx : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2005-10-21
产品信息
- 打开官方文件 ↗
Caelyx pegylated liposomal : EPAR - Product information - tracked changes
product-information-tracked-changes · 2026-04-24
- 打开官方文件 ↗
Caelyx pegylated liposomal : EPAR - Product Information
product-information · 2026-04-24
- 打开官方文件 ↗
Caelyx pegylated liposomal : EPAR - All Authorised presentations
all-authorised-presentations · 2020-03-27
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。