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法规知识库 · EMA 集中审评

Docetaxel Zentiva (previously Docetaxel Winthrop)

docetaxel · EMEA/H/C/000808 · 已撤市

获批上市许可

2007-04-20

欧委会决定日

2022-04-25

持有人 / 申请人

Zentiva k.s.

终止日期字段

无

从产品到官方文件

文件记录

13

官方索引 13

EPAR / 审评

11

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:L01CD02

治疗领域:Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic Neoplasms;Stomach Neoplasms;Breast Neoplasms

药理分类:Antineoplastic agents

修订号:30 · 最新影响 PI 的程序:—

适应症(原文):Breast cancer Docetaxel Winthrop in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Winthrop in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Winthrop monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Winthrop in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Winthrop in combination with capecitabine 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. Non-small-cell lung cancer Docetaxel Winthrop is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Winthrop in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Winthrop in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

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. 2022-04-25 · 欧委会决定

  2. 2007-04-20 · 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 11产品信息 2其他 0

EPAR / 审评资料

  • Docetaxel Zentiva : EPAR - Risk-management-plan summary

    rmp-summary · 2022-05-20

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  • Docetaxel Zentiva-H-C-WS1550 : EPAR - Assessment report - Variation

    variation-report · 2022-05-20 · EMA/647024/2019

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  • Docetaxel Winthrop- H-C-PSUSA-00001152-201611 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

    scientific-conclusion · 2022-05-20 · EMA/841571/2017

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  • Docetaxel Winthrop-H-C-808-P46-0011 : EPAR - Assessment Report

    variation-report · 2022-05-20 · EMA/89165/2013

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  • Docetaxel Winthrop-H-C-808-II-0012 : EPAR - Assessment Report - Variation

    variation-report · 2022-05-20 · EMA/449127/2010

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  • Docetaxel Winthrop-H-C-808-X-0008 : EPAR - Assessment Report - Extension

    variation-report · 2022-05-20 · EMA/774985/2009

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  • Docetaxel Zentiva : EPAR - Medicine overview

    overview · 2022-05-20 · EMA/543296/2019

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  • Docetaxel Zentiva (previously Docetaxel Winthrop) : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2022-05-20

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  • Docetaxel Winthrop-H-C-808-II-0001 : EPAR - Scientific Discussion - Variation

    scientific-discussion-variation · 2022-05-20

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  • Docetaxel Winthrop : EPAR - Procedural steps taken before authorisation

    procedural-steps-before · 2022-05-20

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  • Docetaxel Winthrop : EPAR - Scientific Discussion

    scientific-discussion · 2022-05-20

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产品信息

  • Docetaxel Zentiva : EPAR - Product Information

    product-information · 2022-05-20

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  • Docetaxel Zentiva (previously Docetaxel Winthrop) : EPAR - All Authorised presentations

    all-authorised-presentations · 2022-05-20

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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。