Overview
The marketing authorisation for CEA-Scan has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
CEA-Scan
|
| Agency product number |
EMEA/H/C/000041
|
| Active substance |
arcitumomab
|
| International non-proprietary name (INN) or common name |
arcitumomab
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
V09IA01
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Immunomedics GmbH
|
| Revision |
6
|
| Date of issue of marketing authorisation valid throughout the European Union |
04/10/1996
|
| Contact address |
Immunomedics Europe
Otto-Rà¶hm-Strasse 69 D-64293 Darmstadt Germany |
Product information
26/09/2005 CEA-Scan - EMEA/H/C/000041 -
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Diagnostic radiopharmaceuticals
Therapeutic 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).