法规知识库 · EMA 集中审评
Cyramza
ramucirumab · EMEA/H/C/002829 · 已授权
获批上市许可
2014-12-19
欧委会决定日
2026-01-16
持有人 / 申请人
Eli Lilly Nederland B.V.
终止日期字段
无
从产品到官方文件
文件记录
14
官方索引 14
EPAR / 审评
11
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC:L01FX06
治疗领域:Stomach Neoplasms
药理分类:Antineoplastic agents
修订号:22 · 最新影响 PI 的程序:VR/0000315508
适应症(原文):Gastric cancer Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy. Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate. Colorectal cancer Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5?fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine. Non-small cell lung cancer Cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy. Hepatocellular carcinoma Cyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (AFP) of ? 400 ng/ml and who have been previously treated with sorafenib.
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。
2026-01-16 · 欧委会决定
2014-12-19 · 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
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Cyramza : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-01-16
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Cyramza-H-C-2829-P46-0010 : EPAR - Assessment report
variation-report · 2025-03-26 · EMA/46449/2025
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Cyramza : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2024-10-21
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Cyramza-H-C-2829-P46-009 : EPAR - Assessment report
variation-report · 2023-11-28 · EMA/469034/2023
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Cyramza-H-C-2829-II-0033 : EPAR - Assessment Report - Variation
variation-report · 2020-02-25 · EMA/CHMP/647625/2019
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Cyramza : EPAR - Medicine overview
overview · 2020-02-25 · EMA/8865/2020
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Cyramza : EPAR - Risk-management-plan summary
rmp-summary · 2020-02-25
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Cyramza-H-C-2829-II-0027 : EPAR - Assessment Report - Variation
variation-report · 2019-11-28 · EMA/635673/2019
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Cyramza-H-C-2829-II-0003 : EPAR - Assessment Report - Variation
variation-report · 2016-03-10 · EMA/CHMP/69093/2016
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Cyramza-H-C-2829-II-0004 : EPAR - Assessment Report - Variation
variation-report · 2016-03-10 · EMA/CHMP/69143/2016
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Cyramza : EPAR - Public assessment report
assessment-report · 2015-01-22 · EMA/CHMP/305462/2014
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。