CEA-Scan
Withdrawn
This medicine's authorisation has been withdrawn
arcitumomab
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for CEA-Scan has been withdrawn at the request of the marketing authorisation holder.
Product information
26/09/2005
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
Product details
- Name of medicine
- CEA-Scan
- Active substance
- arcitumomab
- International non-proprietary name (INN) or common name
- arcitumomab
- Therapeutic area (MeSH)
- Radionuclide Imaging
- Colorectal Neoplasms
- Anatomical therapeutic chemical (ATC) code
- V09IA01
Pharmacotherapeutic group
Diagnostic radiopharmaceuticalsTherapeutic 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).
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