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法规知识库 · EMA 集中审评

Alymsys

bevacizumab · EMEA/H/C/005286 · 已授权

生物类似药

获批上市许可

2021-03-26

欧委会决定日

2026-02-06

持有人 / 申请人

Mabxience Research SL

终止日期字段

无

从产品到官方文件

文件记录

10

官方索引 10

EPAR / 审评

7

assessment / overview 等

产品信息

3

PI / presentations

其他

0

RMP / PIP 等

ATC:L01FG01

治疗领域:Colorectal Neoplasms;Breast Neoplasms;Ovarian Neoplasms;Peritoneal Neoplasms;Carcinoma, Non-Small-Cell Lung;Carcinoma, Renal Cell;Uterine Cervical Neoplasms

药理分类:Antineoplastic agents

修订号:12 · 最新影响 PI 的程序:EMA/N/0000326153

适应症(原文):Alymsys in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Alymsys in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. Alymsys in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Alymsys in combination with capecitabine. Alymsys, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer other than predominantly squamous cell histology. Alymsys, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Alymsys in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Alymsys, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Alymsys, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Alymsys, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Alymsys, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

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. 2026-02-06 · 欧委会决定

  2. 2021-03-26 · 获批上市许可

  3. 2021-01-28 · 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 7产品信息 3其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2026-02-06

    打开官方文件 ↗
  • Alymsys-PSUSA-00000403-202502 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2026-01-05 · EMADOC-1700519818-2470418

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

    procedural-steps-after · 2026-01-05

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  • Alymsys-H-C-PSUSA-00000403-202202 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2022-12-15 · EMA/921971/2022

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  • Alymsys : EPAR - Medicine overview

    overview · 2021-04-26 · EMA/64590/2021

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  • Alymsys : EPAR - Risk-management-plan summary

    rmp-summary · 2021-04-26

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  • Alymsys : EPAR - Public assessment report

    assessment-report · 2021-04-26 · EMA/112177/2021

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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。