NeoSpect
Withdrawn
This medicine's authorisation has been withdrawn
depreotide
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 29 November 2000 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product NeoSpect, depreotide, which had been approved for diagnostic use only, for scintigraphic imaging of suspected malignant tumours in the lung after initial detection, in combination with CT scan or chest X-ray, in patients with solitary pulmonary nodules.
The marketing authorisation holder (MAH) responsible for NeoSpect was CIS bio international. The European Commission was notified by a letter dated 30 September 2010 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for NeoSpect for commercial reasons. NeoSpect had been marketed in all European countries.
On 28 October 2010 the European Commission issued a decision to withdraw the marketing authorisation for NeoSpect.
Pursuant to this decision the European Public Assessment Report for NeoSpect is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:N/0015
28/10/2010
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
- NeoSpect
- Active substance
- depreotide trifluoroacetate
- International non-proprietary name (INN) or common name
- depreotide
- Therapeutic area (MeSH)
- Radionuclide Imaging
- Anatomical therapeutic chemical (ATC) code
- V09IA05
Pharmacotherapeutic group
Diagnostic radiopharmaceuticalsTherapeutic indication
This medicinal product is for diagnostic use only.
For scintigraphic imaging of suspected malignant tumours in the lung after initial detection, in
combination with CT scan or chest X-ray, in patients with solitary pulmonary nodules.
Assessment history
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