LeukoScan

sulesomab

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The marketing authorisation for LeukoScan has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
LeukoScan : EPAR - Summary for the public BG = bălgarski 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public ES = español 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public CS = čeština 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public DA = dansk 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public DE = Deutsch 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public ET = eesti keel 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public EL = elliniká 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public EN = English 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public FR = français 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public IT = italiano 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public LV = latviešu valoda 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public LT = lietuvių kalba 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public HU = magyar 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public MT = Malti 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public NL = Nederlands 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public PL = polski 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public PT = português 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public RO = română 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public SK = slovenčina 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public SL = slovenščina 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public FI = suomi 2007-08-13 2018-02-09
LeukoScan : EPAR - Summary for the public SV = svenska 2007-08-13 2018-02-09

This EPAR was last updated on 09/02/2018 .

Authorisation details

Product details

Product details for LeukoScan
NameLeukoScan
Agency product numberEMEA/H/C/000111
Active substance

sulesomab

International non-proprietary name (INN) or common name

sulesomab

Therapeutic area Radionuclide ImagingOsteomyelitis
Anatomical therapeutic chemical (ATC) code V04D

Publication details

Publication details for LeukoScan
Marketing-authorisation holder

Immunomedics GmbH

Revision7
Date of issue of marketing authorisation valid throughout the European Union14/02/1997

Contact address:

Immunomedics GmbH
Otto-Röhm-Straße 69
D-64293 Darmstadt
Germany

Product information

Product information

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

Name Language First published Last updated
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Product Information SV = svenska 2007-08-13 2018-02-09

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.


Name Language First published Last updated
LeukoScan : EPAR - All Authorised presentations SV = svenska 2005-10-21 2018-02-09

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

Changes since initial authorisation of medicine

Name Language First published Last updated
LeukoScan : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2007-08-13 2018-02-09
LeukoScan : EPAR - Steps taken after authorisation when a cutoff date has been used SV = svenska 2005-10-21 2018-02-09

Initial marketing-authorisation documents

Name Language First published Last updated
LeukoScan : EPAR - Procedural steps taken before authorisation SV = svenska 2005-10-21 2018-02-09
LeukoScan : EPAR - Scientific Discussion SV = svenska 2005-10-21 2018-02-09

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on LeukoScan