Ilumira (lutetium (177Lu) chloride)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- lutetium (177Lu) chloride
- Company
- Shine Europe B.V.
- Status
- Authorised
- Therapeutic area
- Radionuclide Imaging
- CHMP opinion
- Thu 29 Jan 2026
- EU approval
- Thu 26 Mar 2026
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006596
- ATC
- V10X
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
Thu 26 Mar 2026🇪🇺 EU approval (EC decision)
Ilumira (lutetium (177Lu) chloride) approved in the EU
Marketing authorisation to Shine Europe B.V.; Additional monitoring · source
Thu 29 Jan 2026🇪🇺 CHMP positive opinion
Ilumira (lutetium (177Lu) chloride): CHMP positive opinion
Shine Europe B.V.; Additional monitoring · source
Same substance in other markets
- 🇪🇺 Theralugand Authorised · Eckert & Ziegler Radiopharma GmbH
- 🇪🇺 EndolucinBeta Authorised · ITM Medical Isotopes GmbH
- 🇪🇺 Lumark Withdrawn · I.D.B. Radiopharmacy B.V.
- 🇪🇺 Lutetium (177Lu) chloride Billev (previously Illuzyce) Authorised · Billev Pharma Aps
Follow Ilumira
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.