法规知识库 · EMA 集中审评
CEA-Scan
arcitumomab · EMEA/H/C/000041 · 已撤市
获批上市许可
1996-10-04
欧委会决定日
2005-09-26
持有人 / 申请人
Immunomedics GmbH
终止日期字段
2005-09-27
从产品到官方文件
文件记录
0
官方索引 0
EPAR / 审评
0
assessment / overview 等
产品信息
0
PI / presentations
其他
0
RMP / PIP 等
ATC:V09IA01
治疗领域:Radionuclide Imaging;Colorectal Neoplasms
药理分类:Diagnostic radiopharmaceuticals
修订号:6 · 最新影响 PI 的程序:—
适应症(原文):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).
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。
2005-09-27 · 上市许可终止(撤市/失效/撤销等)
Withdrawn
2005-09-26 · 欧委会决定
1996-10-04 · 获批上市许可
说明书、EPAR 与其他文件
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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。