CEA-Scan (arcitumomab)
- Region
- 🇪🇺 EU
- Active substance
- arcitumomab
- Company
- Immunomedics GmbH
- Status
- Withdrawn
- Therapeutic area
- Radionuclide Imaging; Colorectal Neoplasms
- EU approval
- Fri 04 Oct 1996
- Application
- EMEA/H/C/000041
- ATC
- V09IA01
- Official record
- www.ema.europa.eu
Indication
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.