法规知识库 · EMA 集中审评
Armisarte (previously Pemetrexed Actavis)
pemetrexed diacid monohydrate · EMEA/H/C/004109 · 已授权
获批上市许可
2016-01-18
欧委会决定日
2024-12-12
持有人 / 申请人
Actavis Group PTC ehf
终止日期字段
无
从产品到官方文件
文件记录
9
官方索引 9
EPAR / 审评
7
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01BA04
治疗领域：Carcinoma, Non-Small-Cell Lung;Mesothelioma
药理分类：Antineoplastic agents
修订号：16 · 最新影响 PI 的程序：PSUSA/00002330/202402
适应症（原文）：Malignant pleural mesothelioma Pemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.
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。
2024-12-12 · 欧委会决定
2016-01-18 · 获批上市许可
2015-11-19 · 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 ↗
Armisarte : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-07-25
- 打开官方文件 ↗
Armisarte : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-07-25
- 打开官方文件 ↗
Armisarte : EPAR - Risk management plan
rmp-summary · 2025-07-25
- 打开官方文件 ↗
Armisarte-PSUSA-00002330-202402 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-02-11 · EMA/42489/2025
- 打开官方文件 ↗
Armisarte-PSUSA-00002330-201802 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-08-27 · EMA/798348/2018
- 打开官方文件 ↗
Pemetrexed Actavis : EPAR - Public assessment report
assessment-report · 2016-01-28 · EMA/819302/2015
- 打开官方文件 ↗
Armisarte : EPAR - Summary for the public
overview · 2016-01-28 · EMA/783156/2015
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。