跳到正文

法规知识库 · EMA 集中审评

Ciambra

pemetrexed disodium hemipentahydrate · EMEA/H/C/003788 · 已撤市

仿制药

获批上市许可

2015-12-02

欧委会决定日

2022-08-17

持有人 / 申请人

Menarini International Operations Luxembourg S.A.

终止日期字段

2023-10-12

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:7 · 最新影响 PI 的程序:IB/0008

适应症(原文):Malignant pleural mesothelioma Ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Ciambra 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. Ciambra 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. Ciambra 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. 2023-10-12 · 上市许可终止(撤市/失效/撤销等)

    Withdrawn

  2. 2022-08-17 · 欧委会决定

  3. 2015-12-02 · 获批上市许可

  4. 2015-09-24 · 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

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

    procedural-steps-after · 2024-10-17

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

    assessment-report · 2024-10-17 · EMA/802052/2015

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

    rmp-summary · 2024-10-17

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

    overview · 2024-10-17 · EMA/802043/2015

    打开官方文件 ↗

产品信息

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。