LeukoScan
Withdrawn
This medicine's authorisation has been withdrawn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Assessment Report (EPAR) for LeukoScan is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IAIN/0024/G
18/01/2017
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).
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 agentsTherapeutic 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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