Overview

The marketing authorisation for LeukoScan has been withdrawn at the request of the marketing authorisation holder.

LeukoScan : EPAR - Summary for the public

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Product information

LeukoScan : EPAR - Product Information

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български (BG) (1.27 MB - PDF)

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čeština (CS) (1.06 MB - PDF)

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dansk (DA) (670.18 KB - PDF)

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ελληνικά (EL) (1.25 MB - PDF)

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italiano (IT) (613.84 KB - PDF)

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latviešu valoda (LV) (1.15 MB - PDF)

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lietuvių kalba (LT) (786.25 KB - PDF)

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magyar (HU) (1.03 MB - PDF)

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Nederlands (NL) (622.94 KB - PDF)

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polski (PL) (1.08 MB - PDF)

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português (PT) (679.29 KB - PDF)

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română (RO) (733.17 KB - PDF)

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slovenčina (SK) (1.04 MB - PDF)

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slovenščina (SL) (1.03 MB - PDF)

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Suomi (FI) (610.22 KB - PDF)

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svenska (SV) (667.87 KB - PDF)

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Latest procedure affecting product information: IAIN/0024/G

18/01/2017

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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).

LeukoScan : EPAR - All Authorised presentations

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Product details

Name of medicine
LeukoScan
Active substance
sulesomab
International non-proprietary name (INN) or common name
sulesomab
Therapeutic area (MeSH)
  • Osteomyelitis
  • Radionuclide Imaging
Anatomical therapeutic chemical (ATC) code
VO4D

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.

Authorisation details

EMA product number
EMEA/H/C/000111
Marketing authorisation holder
Immunomedics GmbH

Otto-Röhm-Straße 69
D-64293 Darmstadt
Germany

Marketing authorisation issued
14/02/1997
Revision
7

Assessment history

LeukoScan : EPAR - Procedural steps taken and scientific information after authorisation

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LeukoScan : EPAR - Steps taken after authorisation when a cutoff date has been used

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LeukoScan : EPAR - Scientific Discussion

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LeukoScan : EPAR - Procedural steps taken before authorisation

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More information on LeukoScan

Public statement on LeukoScan: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/70932/2018

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