Lumark

RSS

lutetium, isotope of mass 177

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

Overview

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

Lumark 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.

Lumark 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 09/04/2018

Authorisation details

Product details
Name
Lumark
Agency product number
EMEA/H/C/002749
Active substance
lutetium, isotope of mass 177
International non-proprietary name (INN) or common name
lutetium, isotope of mass 177
Therapeutic area (MeSH)
Radionuclide Imaging
Anatomical therapeutic chemical (ATC) code
V09
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
I.D.B. Radiopharmacy B.V.
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
19/06/2015
Contact address
I.D.B. Holland B.V.
Weverstraat 17
5111 PV Baarle-Nassau
The Netherlands

Product information

04/04/2018 Lumark - EMEA/H/C/002749 - PSUSA/00010391/201706

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

Lumark is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.

Assessment history

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