Lumark
lutetium (177 Lu) chloride
Table of contents
Overview
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 to be used to radiolabel medicines that have been specifically developed for use with lutetium (177Lu) chloride.
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List item
Lumark : EPAR - Medicine overview (PDF/69.76 KB)
First published: 16/07/2015
Last updated: 14/01/2019
EMA/285451/2015 -
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List item
Lumark : EPAR - Risk-management-plan summary (PDF/80.02 KB)
First published: 16/07/2015
Last updated: 07/05/2020
Authorisation details
Product details | |
---|---|
Name |
Lumark
|
Agency product number |
EMEA/H/C/002749
|
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 |
V10
|
Publication details | |
---|---|
Marketing-authorisation holder |
I.D.B. Radiopharmacy B.V.
|
Revision |
9
|
Date of issue of marketing authorisation valid throughout the European Union |
18/06/2015
|
Contact address |
I.D.B. Holland B.V.
Weverstraat 17 5111 PV Baarle-Nassau The Netherlands |
Product information
17/09/2020 Lumark - EMEA/H/C/002749 - PSUSA/00010391/201912
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Therapeutic 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.