EU/3/20/2280: Orphan designation for the treatment of marginal zone lymphoma

Lutetium (177Lu) lilotomab satetraxetan


On 4 June 2020, orphan designation EU/3/20/2280 was granted by the European Commission to Nordic Nanovector ASA, Norway, for lutetium (177Lu) lilotomab satetraxetan (also known as Betalutin) for the treatment of marginal zone lymphoma.

Key facts

Active substance
Lutetium (177Lu) lilotomab satetraxetan
Intended use
Treatment of marginal zone lymphoma
Orphan designation status
EU designation number
Date of designation

Medpace Finland Oy
Karjalankatu 2
00520 Helsinki
Tel: +1 20 1322 9148

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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