EU/3/06/412: Orphan designation for the treatment of retinitis pigmentosa

4,7,10,13,16,19-docosahexaenoic acid

Table of contents


On 3 November 2006, orphan designation (EU/3/06/412) was granted by the European Commission to Jose Manuel Cela Lopez, Spain, for 4,7,10,13,16,19-docosahexaenoic acid for the treatment of retinitis pigmentosa.

The sponsorship was transferred to Celavista Pharmaceuticals Limited, Ireland, in August 2011 and subsequently to Natac Pharma SL, Spain, in May 2013.

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

Key facts

Active substance
4,7,10,13,16,19-docosahexaenoic acid
Intended use
Treatment of retinitis pigmentosa
Orphan designation status
EU designation number
Date of designation

Celavista Mito-Biogenesis S.L.
Edificio Sede
Parque Científico De La UPV EHU
Barrio Sarriena
48940 Leioa
Tel. +34 684 37 99 56

Update history

May 2023The sponsorship was transferred from Natac Pharma S.L., Spain, to Celavista Mito-Biogenesis S.L., Spain, in May 2023.

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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