法规知识库 · EMA 集中审评
Yondelis
trabectedin · EMEA/H/C/000773 · 已授权
获批上市许可
2007-09-17
欧委会决定日
2026-07-15
持有人 / 申请人
Pharma Mar S.A.
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
13
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01CX01
治疗领域：Ovarian Neoplasms;Sarcoma
药理分类：Antineoplastic agents
修订号：29 · 最新影响 PI 的程序：PSUR/0000321523
适应症（原文）：Yondelis is indicated for the treatment of patients with advanced soft-tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients. Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.
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。
2026-07-15 · 欧委会决定
2007-09-17 · 获批上市许可
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 ↗
Yondelis : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-10-20
- 打开官方文件 ↗
Yondelis-PSUSA-00003001-202509 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-07-20 · EMADOC-1700519818-3344451
- 打开官方文件 ↗
Yondelis : EPAR - Risk management plan
rmp · 2025-04-03
- 打开官方文件 ↗
Yondelis : EPAR - Scientific conclusions - Article 20
scientific-conclusion · 2020-10-09
- 打开官方文件 ↗
Yondelis-PSUSA-00003001-201709 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2018-07-02 · EMA/428932/2018
- 打开官方文件 ↗
Yondelis-H-C-PSUSA-00003001-201609 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2017-06-20 · EMA/CHMP/390382/2017
- 打开官方文件 ↗
Yondelis-H-C-PSUSA-3001-201509 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2016-07-19 · EMA/497086/2016
- 打开官方文件 ↗
Yondelis-H-C-PSUSA-00003001-201409 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-07-13 · EMA/CHMP/331158/2015
- 打开官方文件 ↗
Yondelis : EPAR - Summary for the public
overview · 2015-06-25
- 打开官方文件 ↗
Yondelis-H-C-773-PSUV-0038 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-07-31 · EMEA/H/C/000773/PSUV/0038
- 打开官方文件 ↗
Yondelis-H-C-773-II-0008 : EPAR - Assessment Report - Variation
variation-report · 2010-01-13 · EMEA/640507/2009
- 打开官方文件 ↗
Yondelis : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2007-10-12
- 打开官方文件 ↗
Yondelis : EPAR - Scientific Discussion
scientific-discussion · 2007-10-12
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。