法规知识库 · EMA 集中审评
Apexelsin
paclitaxel · EMEA/H/C/005997 · 已授权
获批上市许可
2024-07-24
欧委会决定日
2025-06-10
持有人 / 申请人
Whiteoak Pharmaceutical B.V.
终止日期字段
无
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:L01CD01
治疗领域:Breast Neoplasms;Pancreatic Neoplasms;Carcinoma, Non-Small-Cell Lung
药理分类:Antineoplastic agents
修订号:2 · 最新影响 PI 的程序:VR/0000272569
适应症(原文):Apexelsin monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. Apexelsin in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Apexelsin in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
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。
2025-06-10 · 欧委会决定
2024-07-24 · 获批上市许可
2024-05-30 · 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 ↗
Apexelsin : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-06-10
- 打开官方文件 ↗
Apexelsin : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-06-10
- 打开官方文件 ↗
Apexelsin : EPAR - Medicine overview
overview · 2024-08-02 · EMA/290084/2024
- 打开官方文件 ↗
Apexelsin : EPAR - Risk management plan
rmp · 2024-08-02
- 打开官方文件 ↗
Apexelsin : EPAR - Public assessment report
assessment-report · 2024-08-02 · EMA/283170/2024
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。