欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Cyramza
适用类别Human
治疗领域Stomach Neoplasms
通用名/非专利名称ramucirumab
活性成分ramucirumab
产品号EMEA/H/C/002829
患者安全信息No
许可状态Authorised
ATC编码L01FX06
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2014/12/19
上市许可开发者/申请人/持有人Eli Lilly Nederland B.V.
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
欧盟委员会决定日期2025/06/17
修订号21
治疗适应症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.
适用物种
兽用药物ATC编码
首次发布日期2018/02/12
最后更新日期2025/06/18
产品说明书https://www.ema.europa.eu/en/documents/product-information/cyramza-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/cyramza
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