EndolucinBeta

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lutetium (177 Lu) chloride

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

Overview

An overview of EndolucinBeta and why it is authorised in the EU

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 is only to be used to radiolabel medicines that have been specifically developed for use with lutetium (177Lu) chloride.

This EPAR was last updated on 05/04/2018

Authorisation details

Product details
Name
EndolucinBeta
Agency product number
EMEA/H/C/003999
Active substance
lutetium (177 Lu) chloride
International non-proprietary name (INN) or common name
lutetium (177 Lu) chloride
Therapeutic area (MeSH)
Radionuclide Imaging
Anatomical therapeutic chemical (ATC) code
V10X
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
ITG Isotope Technologies Garching GmbH
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
05/07/2016
Contact address
Lichtenbergstrasse 1
D-85748 Garching
Germany

Product information

26/03/2018 EndolucinBeta - EMEA/H/C/003999 - PSUSA/00010391/201706

Contents

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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.

Assessment history

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