Scintimun

RSS

besilesomab

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

This EPAR was last updated on 27/10/2016

Authorisation details

Product details
Name
Scintimun
Agency product number
EMEA/H/C/001045
Active substance
besilesomab
International non-proprietary name (INN) or common name
besilesomab
Therapeutic area (MeSH)
  • Osteomyelitis
  • Radionuclide Imaging
Anatomical therapeutic chemical (ATC) code
V09HA03
Publication details
Marketing-authorisation holder
CIS bio international 
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
11/01/2010
Contact address
CIS bio international
Route Nationale 306, BP 32
F-91192 Gif-sur-Yvette
Cedex
France

Product information

22/09/2016 Scintimun - EMEA/H/C/001045 - II/0010/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

DIAGNOSTIC RADIOPHARMACEUTICALS

Therapeutic indication

This medicinal product is for diagnostic use only and the approved indication is 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.

Assessment history

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