NeoSpect

Withdrawn

This medicine's authorisation has been withdrawn

depreotide

Overview

The marketing authorisation for NeoSpect has been withdrawn at the request of the marketing authorisation holder.

NeoSpect : EPAR - Summary for the public

Product information

NeoSpect : EPAR - 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).

NeoSpect : EPAR - All Authorised presentations

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
• Revision:
  10

Assessment history

Changes since initial authorisation of medicine

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

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

Initial marketing authorisation documents

NeoSpect : EPAR - Scientific Discussion

NeoSpect : EPAR - Procedural steps taken before authorisation