Ilumira

Opinion

EMA has issued an opinion on this medicine

lutetium (177Lu) chloride

Overview

On 29 January 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ilumira, a radiopharmaceutical precursor. Ilumira is not intended for direct use in patients and must be used only for the radiolabelling of carrier medicines that have been specifically developed and authorised for radiolabelling with lutetium (¹⁷⁷Lu) chloride.

The applicant for this medicinal product is SHINE Europe B.V.

Ilumira will be available as a solution containing 37 GBq/ml radiopharmaceutical precursor. The active substance of Ilumira is lutetium (¹⁷⁷Lu) chloride, a therapeutic radiopharmaceutical (ATC code: V10X), which is a radioactive isotope of lutetium that emits beta-minus and gamma radiation. The effect of Ilumira depends on the nature of the carrier medicine radiolabelled with the product.

The clinical utility of lutetium (¹⁷⁷Lu) when attached to relevant carrier medicines was demonstrated based on an extensive review of the literature, for example in the treatment of patients with neuroendocrine tumours or prostate cancer. Unfavourable effects relating to radiation exposure can occur with Ilumira, as is the case with all radionuclides in clinical use. These effects, which include carcinogenicity and mutagenicity, will depend on the carrier medicine radiolabelled with lutetium (¹⁷⁷Lu).

In addition to radiation exposure for the patient, there is also a risk of radiation exposure for individuals in close proximity to the patient. A judgement on whether these risks are acceptable in any particular case can only be made in subsequent applications for carrier medicines intending to use Ilumira as a radiolabel.

The full indication is:

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.

Ilumira should only be used by specialists experienced with in vitro radiolabelling.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Ilumira

Adopted Reference Number: EMADOC-1829012207-40538

Product details

• Name of medicine:
  Ilumira
• 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:
  V10X
• EMA product number:
  EMEA/H/C/006596
• Marketing authorisation applicant:
  Shine Europe B.V.
• Opinion adopted:
  29/01/2026
• Opinion status:
  Positive