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Pharmaceuticals - Community Register
Community register of medicinal products for human use |
AUTHORISED |
Product information |
Invented name: | Scintimun
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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
Boite Postale 32, 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 procedures |
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/9 | ||||
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 |