欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称CEA-Scan
适用类别Human
治疗领域Radionuclide Imaging;Colorectal Neoplasms
通用名/非专利名称arcitumomab
活性成分arcitumomab
产品号EMEA/H/C/000041
患者安全信息No
许可状态Withdrawn
ATC编码V09IA01
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1996/10/04
上市许可开发者/申请人/持有人Immunomedics GmbH
人用药物治疗学分组Diagnostic radiopharmaceuticals
兽用药物治疗学分组
欧盟委员会决定日期2005/09/26
修订号6
治疗适应症CEA-Scan is indicated only in patients with histologically-demonstrated carcinoma of the colon or rectum for imaging of recurrence and/or metastases. CEA-Scan is employed for diagnostic use only, in the above mentioned patients, as an adjunct to standard non-invasive imaging techniques, such as ultrasonography or CT scan, in the following situations: Patients with evidence of recurrence and/or metastatic carcinoma of the colon or rectum, who are undergoing an evaluation for extent of disease, such as prior to surgical resection and/or other therapy, or Patients with suspected recurrence and/or metastatic carcinoma of the colon or rectum in association with rising levels of carcinoembryonic antigen (CEA).
适用物种
兽用药物ATC编码
首次发布日期2005/09/26
最后更新日期2005/11/16
产品说明书
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/cea-scan
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