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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for LeukoScan has been withdrawn at the request of the marketing authorisation holder.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

Other EU languages available icon 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).

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 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

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