Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Scintimun   
Auth. number : EU/1/09/602
INN : besilesomab
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: V09HA03 - Technetium (99mTc) antigranulocyte antibody
(See WHO ATC Index)
Indication: For diagnostic use only. Scintigraphic imaging for determining the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis. Should not be used for the diagnosis of diabetic foot infection.
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 continues to be 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
15/01/2010 Centralised - Authorisation EMEA/H/C/1045 (2010)97 of 11/01/2010
26/07/2010 Centralised - Variation EMEA/H/C/1045/IB/1
Updated with Decision(2011)2100 of 24/03/2011
09/09/2010 Centralised - Variation EMEA/H/C/1045/IG/15
Updated with Decision(2011)2100 of 24/03/2011
29/03/2011 Centralised - Variation (2011)2100 of 24/03/2011