EU/3/16/1811: Orphan designation for the treatment of glioma

5-aminolevulinic acid


On 12 January 2017, orphan designation (EU/3/16/1811) was granted by the European Commission to Centre Hospitalier Universitaire de Lille, France, for 5-aminolevulinic acid for the treatment of glioma.

Key facts

Active substance
5-aminolevulinic acid
Medicine name
Intended use
Treatment of glioma
Orphan designation status
EU designation number
Date of designation

Hemerion Therapeutics
37 Rue Denis Papin 
59650 Villeneuve d’Ascq 

Review of designation

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

Update history

March 2023The sponsor's address was updated.
December 2020The sponsorship was transferred to Hemerion Therapeutics, France. 

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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