LeukoScan
sulesomab
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for LeukoScan has been withdrawn at the request of the marketing authorisation holder.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) |
|
| 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 | |
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
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Pharmacotherapeutic group
Pharmacotherapeutic group
Diagnostic agents
Therapeutic indication
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.