CEA-Scan

RSS

arcitumomab

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for CEA-Scan has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 15/11/2005

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)
  • Radionuclide Imaging
  • Colorectal Neoplasms
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
03/10/1996
Contact address
Immunomedics Europe
Otto-Rà¶hm-Strasse 69
D-64293 Darmstadt
Germany

Product information

25/09/2005 CEA-Scan - EMEA/H/C/000041 -

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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).

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