Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: NeoSpect
Auth. number : EU/1/00/154
INN : Depreotide
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V09 - Diagnostic radiopharmaceuticals
Pharmacological subgroup: V09I - Tumour detection
Chemical subgroup: V09IA - Technetium (99mTc) compounds
Chemical substance: V09IA05 - Technetium (99mTc) depreotide
(See WHO ATC Index)
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.
Marketing Authorisation Holder: CIS bio international
route Nationale 306, Saclay, Boite Postale 32, F-91192 Gif-sur-Yvette, France

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
04/12/2000 Centralised - Authorisation EMEA/H/C/263 (2000)3394 of 29/11/2000
22/05/2001 Centralised - Notification EMEA/H/C/263/N/1 (2001)1243 of 18/05/2001
25/02/2002 Centralised - Variation EMEA/H/C/263/I/2 (2002)660 of 19/02/2002
03/07/2003 Centralised - Variation EMEA/H/C/263/I/3 (2003)2230 of 30/06/2003
29/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/263/IB/4
16/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/263/IB/74
16/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/263/IB/8
02/02/2006 Centralised - Renewal EMEA/H/C/263/R/6 (2006)307 of 31/01/2006
24/03/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/263/T/9 (2006)1043 of 22/03/2006
31/05/2006 Centralised - Variation EMEA/H/C/263/IA/10
Updated with Decision(2006)7005 of 18/12/2006
01/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/263/IB/12
01/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/263/IB/11
26/09/2006 Centralised - Notification EMEA/H/C/263/N/13
Updated with Decision(2006)7005 of 18/12/2006
21/12/2006 Centralised - Variation (2006)7005 of 18/12/2006
17/08/2007 Centralised - Notification EMEA/H/C/263/N/14
15/04/2008 Centralised - Notification EMEA/H/C/263/N/15
05/11/2010 Centralised - Withdrawal (2010)7625 of 28/10/2010