NeoSpect

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Withdrawn

This medicine's authorisation has been withdrawn

depreotide
MedicineHumanWithdrawn
  • 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decision the European Public Assessment Report for NeoSpect is updated to reflect that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: N/0015
28/10/2010
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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).

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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 radiopharmaceuticals

Therapeutic 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.

Authorisation details

EMA product number
EMEA/H/C/000263
Marketing authorisation holder
CIS bio international

Route Nationale 306, Saclay
B.P. 32
F-91192 Gif sur Yvette Cedex
France

Marketing authorisation issued
29/11/2000
Withdrawal of marketing authorisation
28/10/2010
Revision
10

Assessment history

This page was last updated on

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