LeukoScan

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Withdrawn

This medicine's authorisation has been withdrawn

sulesomab
MedicineHumanWithdrawn

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  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 30 January 2018, the European Commission withdrew the marketing authorisation for LeukoScan (sulesomab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Immunomedics GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

LeukoScan was granted marketing authorisation in the EU on 14 February 1997 for diagnostic imaging in suspected osteomyelitis. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in year 2002. It was then granted unlimited validity in 2007. 

The European Public Assessment Report (EPAR) for LeukoScan is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

LeukoScan : EPAR - Summary for the public

English (EN) (516.27 KB - PDF)

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български (BG) (716 KB - PDF)

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español (ES) (517.76 KB - PDF)

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čeština (CS) (685.63 KB - PDF)

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dansk (DA) (517.71 KB - PDF)

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Deutsch (DE) (519.14 KB - PDF)

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eesti (ET) (516.76 KB - PDF)

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ελληνικά (EL) (711.69 KB - PDF)

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français (FR) (516.17 KB - PDF)

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italiano (IT) (519.32 KB - PDF)

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latviešu (LV) (690.36 KB - PDF)

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lietuvių (LT) (656.6 KB - PDF)

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magyar (HU) (676.17 KB - PDF)

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Malti (MT) (688.96 KB - PDF)

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Nederlands (NL) (518.44 KB - PDF)

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polski (PL) (691.01 KB - PDF)

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português (PT) (520.24 KB - PDF)

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română (RO) (650.61 KB - PDF)

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slovenčina (SK) (680.33 KB - PDF)

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slovenščina (SL) (673.42 KB - PDF)

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suomi (FI) (516.88 KB - PDF)

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svenska (SV) (517.53 KB - PDF)

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Product information

LeukoScan : EPAR - Product Information

English (EN) (611.18 KB - PDF)

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български (BG) (1.27 MB - PDF)

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español (ES) (624.63 KB - 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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Deutsch (DE) (623.7 KB - PDF)

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eesti (ET) (616.86 KB - PDF)

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ελληνικά (EL) (1.25 MB - PDF)

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français (FR) (684.89 KB - PDF)

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hrvatski (HR) (752.92 KB - PDF)

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italiano (IT) (613.84 KB - PDF)

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latviešu (LV) (1.15 MB - PDF)

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lietuvių (LT) (786.25 KB - PDF)

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magyar (HU) (1.03 MB - PDF)

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Malti (MT) (975.04 KB - 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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Íslenska (IS) (612.91 KB - PDF)

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norsk (NO) (606.27 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

English (EN) (466.59 KB - PDF)

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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
Withdrawal of marketing authorisation
30/01/2018
Revision
7

Assessment history

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

English (EN) (566.84 KB - PDF)

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

English (EN) (571.74 KB - PDF)

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LeukoScan : EPAR - Scientific Discussion

English (EN) (692.83 KB - PDF)

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LeukoScan : EPAR - Procedural steps taken before authorisation

English (EN) (548.33 KB - PDF)

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