EU/3/14/1248: Orphan designation for the treatment of optic neuritis



On 19 February 2014, orphan designation (EU/3/14/1248) was granted by the European Commission to Bionure Farma SL, Spain, for N-({Carbamoylmethyl-[3-(2-oxo-pyrrolidin-1-yl)-propyl]-carbamoyl}-methyl)-2-[2-(2-fluoro-phenyl)-ethylamino]-N-isobutyl-acetamide for the treatment of optic neuritis.

For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.

Key facts

Active substance
Intended use
Treatment of optic neuritis
Orphan designation status
EU designation number
Date of designation

Accure Therapeutics S.L.
Calle Baldiri Reixac 4-8
Poligono Industrial Parc Cientific De
08028 Barcelona

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

Date Update
July 2022 The sponsor's name was changed from Bionure Farma SL to Accure Therapeutics S.L. and the address was updated in July 2022.

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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