法规知识库 · EMA 集中审评
HumaSPECT
votumumab · EMEA/H/C/000145 · 已撤市
获批上市许可
1998-09-25
欧委会决定日
2003-09-24
持有人 / 申请人
KS Biomedix Limited
终止日期字段
2003-09-24
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:V09IX
治疗领域:Ultrasonography;Colorectal Neoplasms;Tomography, X-Ray Computed
药理分类:Diagnostic radiopharmaceuticals
修订号:— · 最新影响 PI 的程序:—
适应症(原文):After reconstitution with sodium pertechnetate [99mTc] solution, HumaSPECT [99mTc] is indicated in patients with histologically proven carcinoma of the colon or rectum for imaging of recurrence and/or metastases. HumaSPECT [99mTc] is employed, 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.• 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。
2003-09-24 · 欧委会决定
2003-09-24 · 上市许可终止(撤市/失效/撤销等)
Withdrawn
1998-09-25 · 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。