EMA — authorised 18 June 2015
- Marketing authorisation holder: I.D.B. Radiopharmacy B.V.
- Status: approved
🇪🇺 Lumark in European Union
EMA authorised Lumark on 18 June 2015
Marketing authorisations
EMA — authorised 18 June 2015
- Application: EMEA/H/C/002749
- Marketing authorisation holder: I.D.B. Radiopharmacy B.V.
- Local brand name: Lumark
- 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.
- Status: withdrawn
EMA — authorised 6 July 2016
- Application: EMEA/H/C/003999
- Marketing authorisation holder: ITM Medical Isotopes GmbH
- Local brand name: EndolucinBeta
- 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.
- Status: approved
EMA — authorised 15 September 2022
- Application: EMEA/H/C/005859
- Marketing authorisation holder: Billev Pharma Aps
- Local brand name: Lutetium (177Lu) chloride Billev (previously Illuzyce)
- Indication: Lutetium (177Lu) chloride Billev 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.
- Status: approved
EMA — authorised 22 November 2024
- Application: EMEA/H/C/005882
- Marketing authorisation holder: Eckert & Ziegler Radiopharma GmbH
- Local brand name: Theralugand
- Indication: Theralugand 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.
- Status: approved
The European Medicines Agency (EMA) approved Theralugand (Lumark) for marketing authorisation on 22 November 2024. This radiopharmaceutical precursor is intended for use in radiolabelling carrier molecules specifically developed and authorised for radiolabelling with lutetium (177Lu) chloride. It is not intended for direct use in patients.
EMA — authorised 26 March 2026
- Application: EMEA/H/C/006596
- Marketing authorisation holder: Shine Europe B.V.
- Local brand name: Ilumira
- Indication: Ilumira 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.
- Status: approved
The European Medicines Agency (EMA) approved Lumark (Ilumira) for use in the European Union. This radiopharmaceutical precursor is intended for radiolabelling carrier molecules specifically developed and authorised for use with lutetium (177Lu) chloride. The marketing authorisation holder is Shine Europe B.V.
Lumark in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in European Union
Frequently asked questions
Is Lumark approved in European Union?
Yes. EMA authorised it on 18 June 2015; EMA authorised it on 18 June 2015; EMA authorised it on 6 July 2016.
Who is the marketing authorisation holder for Lumark in European Union?
I.D.B. Radiopharmacy B.V. holds the EU marketing authorisation.