EndolucinBeta
lutetium (177 Lu) chloride
Table of contents
Overview
EndolucinBeta contains the radioactive compound lutetium (177Lu) chloride and is used for radiolabelling other medicines. Radiolabelling is a technique for tagging (or labelling) medicines with radioactive compounds so they can carry radioactivity to where it is needed in the body, for example the site of a tumour.
EndolucinBeta isl to be used to radiolabel medicines that have been specifically developed for use with lutetium (177Lu) chloride.
Authorisation details
Product details | |
---|---|
Name |
EndolucinBeta
|
Agency product number |
EMEA/H/C/003999
|
Active substance |
lutetium (177Lu) chloride
|
International non-proprietary name (INN) or common name |
lutetium (177 Lu) chloride
|
Therapeutic area (MeSH) |
Radionuclide Imaging
|
Anatomical therapeutic chemical (ATC) code |
V10X
|
Publication details | |
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Marketing-authorisation holder |
ITM Medical Isotopes GmbH
|
Revision |
8
|
Date of issue of marketing authorisation valid throughout the European Union |
06/07/2016
|
Contact address |
Product information
08/02/2021 EndolucinBeta - EMEA/H/C/003999 - R/0019
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
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Pharmacotherapeutic group
Therapeutic radiopharmaceuticals
Therapeutic indication
EndolucinBeta is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with Lutetium (177Lu) chloride.