EU/3/20/2264: Orphan designation for the treatment of autosomal recessive congenital ichthyosis



On 24 March 2020, orphan designation EU/3/20/2264 was granted by the European Commission to Premier Research Group S.L., Spain, for trifarotene (also known as CD5789) for the treatment of autosomal recessive congenital ichthyosis.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in June 2022 on request of the Sponsor.

Key facts

Active substance
Intended use
Treatment of autosomal recessive congenital ichthyosis
Orphan designation status
EU designation number
Date of designation

Premier Research Group S.L.
Camino De La Zarzuela 19
28023 Madrid
Tel. +34 91038 8900

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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