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法规知识库 · EMA 集中审评

Taxespira (previously Docetaxel Hospira UK Limited )

docetaxel trihydrate · EMEA/H/C/003925 · 已撤市

仿制药

获批上市许可

2015-08-28

欧委会决定日

2018-10-30

持有人 / 申请人

Hospira UK Limited

终止日期字段

2018-10-30

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:L01CD02

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

药理分类:Antineoplastic agents

修订号:8 · 最新影响 PI 的程序:IB/0011

适应症(原文):Breast cancer Taxespira 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. Taxespira 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. Taxespira 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. Taxespira combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease. Taxespira 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 Taxespira indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. Taxespira 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 Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Taxespira 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 Taxespira 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. 2018-10-30 · 欧委会决定

  2. 2018-10-30 · 上市许可终止(撤市/失效/撤销等)

    Withdrawn

  3. 2015-08-28 · 获批上市许可

  4. 2015-05-20 · 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

  • Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2019-10-15

    打开官方文件 ↗
  • Docetaxel Hospira UK Limited : EPAR - Public assessment report

    assessment-report · 2019-10-15 · EMA/CHMP/289489/2015

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  • Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Risk-management-plan summary

    rmp-summary · 2019-10-15

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  • Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public

    overview · 2019-10-15 · EMA/471475/2015

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产品信息

  • Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations

    all-authorised-presentations · 2019-10-15

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  • Taxespira : EPAR - Product Information

    product-information · 2019-10-15

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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。