跳到正文

法规知识库 · EMA 集中审评

Pemetrexed Sandoz

pemetrexed disodium hemipentahydrate · EMEA/H/C/004011 · 已撤市

仿制药

获批上市许可

2015-09-18

欧委会决定日

2024-09-04

持有人 / 申请人

Sandoz GmbH

终止日期字段

2024-10-09

从产品到官方文件

文件记录

6

官方索引 6

EPAR / 审评

4

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:9 · 最新影响 PI 的程序:N/0000224542

适应症(原文):Malignant pleural mesothelioma Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Sandoz 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 Sandoz 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 Sandoz 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。

  1. 2024-10-09 · 上市许可终止(撤市/失效/撤销等)

    Withdrawn

  2. 2024-09-04 · 欧委会决定

  3. 2015-09-18 · 获批上市许可

  4. 2015-07-23 · 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 4产品信息 2其他 0

EPAR / 审评资料

  • Pemetrexed Sandoz : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2024-11-06

    打开官方文件 ↗
  • Pemetrexed Sandoz : EPAR - Summary for the public

    overview · 2024-11-06 · EMA/509171/2015

    打开官方文件 ↗
  • Pemetrexed Sandoz : EPAR - Public assessment report

    assessment-report · 2024-11-06 · EMA/CHMP/467935/2015

    打开官方文件 ↗
  • Pemetrexed Sandoz : EPAR - Risk-management-plan summary

    rmp-summary · 2024-11-06 · EMA/520309/2015

    打开官方文件 ↗

产品信息

  • Pemetrexed Sandoz : EPAR - All Authorised presentations

    all-authorised-presentations · 2024-11-06

    打开官方文件 ↗
  • Pemetrexed Sandoz : EPAR - Product Information

    product-information · 2024-11-06

    打开官方文件 ↗

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。