跳到正文

法规知识库 · EMA 集中审评

Capecitabine Medac

capecitabine · EMEA/H/C/002568 · 已授权

仿制药

获批上市许可

2012-11-19

欧委会决定日

2025-03-28

持有人 / 申请人

medac Gesellschaft für klinische Spezialpräparate mbH

终止日期字段

无

从产品到官方文件

文件记录

8

官方索引 8

EPAR / 审评

6

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:L01BC06

治疗领域:Colorectal Neoplasms

药理分类:Antineoplastic agents

修订号:14 · 最新影响 PI 的程序:PSUSA/00000531/202404

适应症(原文):Capecitabine Medac is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Capecitabine Medac is indicated for the treatment of metastatic colorectal cancer. Capecitabine Medac is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Capecitabine Medac in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Capecitabine Medac is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

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. 2025-03-28 · 欧委会决定

  2. 2012-11-19 · 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 6产品信息 2其他 0

EPAR / 审评资料

  • Capecitabine Medac-H-C-PSUSA-00000531-202404 : EPAR Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2025-05-02 · EMA/151502/2025

    打开官方文件 ↗
  • Capecitabine Medac : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2025-05-02

    打开官方文件 ↗
  • Capecitabine Medac-H-C-1481-A31-0021 : EPAR - Assessment Report - Article 31

    variation-report · 2020-08-05 · EMA/274404/2020

    打开官方文件 ↗
  • Capecitabine Medac : EPAR - Scientific conclusions

    scientific-conclusion · 2020-08-05

    打开官方文件 ↗
  • Capecitabine Medac : EPAR - Medicine overview

    overview · 2020-08-05 · EMA/372533/2020

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

    assessment-report · 2012-11-29 · EMA/711212/2012

    打开官方文件 ↗

产品信息

  • Capecitabine Medac : EPAR - Product Information

    product-information · 2025-05-02

    打开官方文件 ↗
  • Capecitabine Medac : EPAR - All Authorised presentations

    all-authorised-presentations · 2022-04-25

    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。