LeukoScan

RSS

sulesomab

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for LeukoScan has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 09/02/2018

Authorisation details

Product details
Name
LeukoScan
Agency product number
EMEA/H/C/000111
Active substance
sulesomab
International non-proprietary name (INN) or common name
sulesomab
Therapeutic area (MeSH)
  • Osteomyelitis
  • Radionuclide Imaging
Anatomical therapeutic chemical (ATC) code
VO4D
Publication details
Marketing-authorisation holder
Immunomedics GmbH
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
14/02/1997
Contact address
Otto-Röhm-Straße 69
D-64293 Darmstadt
Germany

Product information

18/01/2017 LeukoScan - EMEA/H/C/000111 - IAIN/0024/G

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 AGENTS

Therapeutic indication

This medicinal product is for diagnostic use only.

LeukoScan is indicated for diagnostic imaging for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.

LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.

Assessment history

How useful was this page?

Add your rating