Lumark

Withdrawn

This medicine's authorisation has been withdrawn

lutetium (177Lu) chloride

Overview

On 16 January 2026, the European Commission withdrew the marketing authorisation for Lumark (lutetium (¹⁷⁷Lu) chloride) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, I.D.B. Holland B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Lumark was granted marketing authorisation in the EU on 19 June 2015 for the radiolabelling of carrier molecules. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2020. The last manufacturing of Lumark from the registered site was in December 2022. The product has not been marketed in the EU since, and there is no remaining product on the market.

Lumark (lutetium (¹⁷⁷Lu) chloride) is a radiopharmaceutical precursor used for the radiolabelling of carrier molecules. There are other medicinal products containing lutetium (¹⁷⁷Lu) chloride authorised and marketed in the EU for the radiolabelling of carrier molecules.

Lumark : EPAR - Medicine overview

Reference Number: EMA/285451/2015

Lumark : EPAR - Risk-management-plan summary

Product information

Lumark : EPAR - Product Information

Lumark : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Lumark
• Active substance:
  lutetium (177Lu) chloride
• International non-proprietary name (INN) or common name:
  lutetium (177Lu) chloride
• Therapeutic area (MeSH):
  Radionuclide Imaging
• Anatomical therapeutic chemical (ATC) code:
  V10

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002749
• Marketing authorisation holder:
  I.D.B. Radiopharmacy B.V.

  I.D.B. Holland B.V.; Weverstraat 17 ; 5111 PV Baarle-Nassau ; The Netherlands

• Opinion adopted:
  22/04/2015
• Marketing authorisation issued:
  18/06/2015
• Withdrawal of marketing authorisation:
  16/01/2026
• Revision:
  9

Assessment history

Changes since initial authorisation of medicine

Lumark : EPAR - Procedural steps taken and scientific information after authorisation

Lumark-H-C-PSUSA-00010391-201912 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Adopted Reference Number: EMA/509367/2020

Lumark-H-C-PSUSA-00010391-201812 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/449645/2019

Lumark-H-C-PSUSA-00010391-201806 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Adopted Reference Number: EMA/199298/2019

Lumark-H-C-PSUSA-00010391-201712 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/895480/2018

Lumark-H-C-PSUSA-00010391-201706 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Adopted Reference Number: EMA/207706/2018

Lumark-H-C-PSUSA-00010391-201612 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/686367/2017

Initial marketing authorisation documents

Lumark : EPAR - Public assessment report

Adopted Reference Number: EMA/427491/2015

CHMP summary of positive opinion for Lumark

Adopted Reference Number: EMA/247591/2015