Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Scintimun   
Auth. number : EU/1/09/602
Active substance : 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: This medicinal product is for diagnostic use only.

After radiolabelling with sodium pertechnetate (99mTc) solution, the technetium (99mTc) besilesomab solution obtained is indicated in adults for scintigraphic imaging, in conjunction with other appropriate imaging modalities, for determining the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis.

Scintimun should not be used for the diagnosis of diabetic foot infection.
Marketing Authorisation Holder: CIS bio international
Boîte 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
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
28/08/2014 Centralised - Renewal EMEA/H/C/1045/R/5 (2014)6182 of 26/08/2014
11/02/2016 Centralised - Variation EMEA/H/C/1045/IB/09
Updated with Decision(2017) 788 of 06/02/2017
24/02/2016 Centralised - 2-Monthly update EMEA/H/C/1045/IB/7 (2016)1212 of 22/02/2016
22/09/2016 Centralised - Variation EMEA/H/C/1045/II/10/G
Updated with Decision(2017) 788 of 06/02/2017
08/02/2017 Centralised - Yearly update (2017) 788 of 06/02/2017