Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: LeukoScan   
Auth. number : EU/1/97/032
Active substance : Sulesomab
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V09 - Diagnostic radiopharmaceuticals
Pharmacological subgroup: V09H - Inflammation and infection detection
Chemical subgroup: V09HA - Technetium (99mTc) compounds
Chemical substance: V09HA04 - Technetium (99mTc) sulesomab
(See WHO ATC Index)
Indication: This medicinal product is for diagnostic use only.
LeukoScan is indicated for diagnostic imaging for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.
LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.
Marketing Authorisation Holder: Immunomedics GmbH
Otto-Röhm-Straße 69, D-64293 Darmstadt, Deutschland
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
17/02/1997 Centralised - Authorisation EMEA/H/C/111 (97)451 of 14/02/1997
18/06/1997 Centralised - Variation (no change in Commission Decision) EMEA/H/C/111/II/1
10/10/1997 Centralised - Variation EMEA/H/C/111/I/2 (97)2986 of 08/10/1997
04/04/1999 Centralised - Variation EMEA/H/C/111/I/5 (1999)835 of 29/03/1999
04/04/1999 Centralised - Variation EMEA/H/C/111/I/3 (1999)835 of 29/03/1999
04/04/1999 Centralised - Variation EMEA/H/C/111/I/6 (1999)835 of 29/03/1999
30/06/1999 Centralised - Variation EMEA/H/C/111/I/7, 8 (1999)2834 of 18/06/1999
13/08/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/111/I/9
08/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/111/I/11
20/03/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/111/I/12
24/09/2002 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/111/T/16 (2002)3546 of 18/09/2002
04/10/2002 Centralised - Renewal EMEA/H/C/111/R/13 (2002)3640 of 30/09/2002
17/10/2002 Centralised - Variation EMEA/H/C/111/I/15 (2002)2296 of 17/06/2002
17/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/111/I/17
19/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/111/II/19
30/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/111/I/18
01/06/2007 Centralised - Renewal EMEA/H/C/111/R/20 (2007)2353 of 30/05/2007
25/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/111/II/21