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法规知识库 · EMA 集中审评

Capecitabine Teva

capecitabine · EMEA/H/C/002362 · 已授权

仿制药

获批上市许可

2012-04-20

欧委会决定日

2025-07-10

持有人 / 申请人

Teva Pharma B.V.

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:Colonic Neoplasms;Breast Neoplasms;Colorectal Neoplasms;Stomach Neoplasms

药理分类:Antineoplastic agents

修订号:17 · 最新影响 PI 的程序:VR/0000282000

适应症(原文):Capecitabine Teva is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer. Capecitabine Teva is indicated for the treatment of metastatic colorectal cancer. Capecitabine Teva is indicated for first?line treatment of advanced gastric cancer in combination with a platinum?based regimen. Capecitabine Teva 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 Teva 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. 2025-07-10 · 欧委会决定

  2. 2012-04-20 · 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 Teva : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2025-07-11

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  • Capecitabine Teva : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2025-07-11

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  • Capecitabine Teva : EPAR - Scientific conclusions - Annex V

    scientific-conclusion · 2020-07-29

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  • Capecitabine Teva-H-C-2362-A31-1481-C-2362-31 : EPAR - Assessment report - Article 31

    variation-report · 2020-07-29 · EMA/274404/2020

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  • Capecitabine Teva : EPAR - Medicine overview

    overview · 2020-07-29 · EMA/375695/2020

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  • Capecitabine Teva : EPAR - Public assessment report

    assessment-report · 2012-05-11 · EMA/275974/2012

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产品信息

  • Capecitabine Teva : EPAR - Product Information

    product-information · 2025-07-11

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  • Capecitabine Teva : EPAR - All Authorised presentations

    all-authorised-presentations · 2012-05-11

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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。