NeoSpect

depreotide

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The marketing authorisation for NeoSpect has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
NeoSpect : EPAR - Summary for the public BG = bălgarski 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public ES = español 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public CS = čeština 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public DA = dansk 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public DE = Deutsch 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public ET = eesti keel 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public EL = elliniká 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public EN = English 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public FR = français 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public IT = italiano 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public LV = latviešu valoda 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public LT = lietuvių kalba 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public HU = magyar 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public MT = Malti 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public NL = Nederlands 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public PL = polski 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public PT = português 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public RO = română 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public SK = slovenčina 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public SL = slovenščina 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public FI = suomi 06/11/2007 18/11/2010
NeoSpect : EPAR - Summary for the public SV = svenska 06/11/2007 18/11/2010

This EPAR was last updated on 18/11/2010 .

Authorisation details

Product details

Product details for NeoSpect
NameNeoSpect
Agency product numberEMEA/H/C/000263
Active substance

depreotide trifluoroacetate

International non-proprietary name (INN) or common name

depreotide

Therapeutic area Radionuclide Imaging
Anatomical therapeutic chemical (ATC) code V09IA05

Publication details

Publication details for NeoSpect
Marketing-authorisation holder

CIS bio international

Revision10
Date of issue of marketing authorisation valid throughout the European Union29/11/2000

Contact address:

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

Product information

Product information

28/10/2010  NeoSpect -EMEA/H/C/000263 -N/0015

Name Language First published Last updated
NeoSpect : EPAR - Product Information BG = bălgarski 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information ES = español 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information CS = čeština 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information DA = dansk 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information DE = Deutsch 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information ET = eesti keel 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information EL = elliniká 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information EN = English 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information FR = français 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information IT = italiano 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information LV = latviešu valoda 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information LT = lietuvių kalba 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information HU = magyar 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information MT = Malti 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information NL = Nederlands 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information PL = polski 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information PT = português 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information RO = română 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information SK = slovenčina 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information SL = slovenščina 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information FI = suomi 23/04/2008 18/11/2010
NeoSpect : EPAR - Product Information SV = svenska 23/04/2008 18/11/2010

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
NeoSpect : EPAR - All Authorised presentations BG = bălgarski 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations ES = español 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations CS = čeština 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations DA = dansk 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations DE = Deutsch 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations ET = eesti keel 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations EL = elliniká 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations EN = English 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations FR = français 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations IT = italiano 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations LV = latviešu valoda 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations LT = lietuvių kalba 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations HU = magyar 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations MT = Malti 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations NL = Nederlands 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations PL = polski 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations PT = português 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations RO = română 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations SK = slovenčina 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations SL = slovenščina 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations FI = suomi 12/05/2006 18/11/2010
NeoSpect : EPAR - All Authorised presentations SV = svenska 12/05/2006 18/11/2010

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
NeoSpect : EPAR - Procedural steps taken and scientific information after authorisation (English only) 23/04/2008 18/11/2010
NeoSpect : EPAR - Steps taken after authorisation when a cutoff date has been used (English only) 12/05/2006 18/11/2010

Initial marketing-authorisation documents

Name Language First published Last updated
NeoSpect : EPAR - Scientific Discussion (English only) 12/05/2006 18/11/2010
NeoSpect : EPAR - Procedural steps taken before authorisation (English only) 12/05/2006 18/11/2010

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on NeoSpect