EU/3/18/2110: Orphan designation for the treatment of Fanconi anaemia



On 14 December 2018, orphan designation (EU/3/18/2110) was granted by the European Commission to Consorcio Centro de Investigación Biomédica en Red, M.P., Spain, for afatinib for the treatment of Fanconi anaemia.

Key facts

Active substance
Intended use
Treatment of Fanconi anaemia
Orphan designation status
EU designation number
Date of designation

Consorcio Centro de Investigación Biomédica en Red, M.P.
Instituto de Salud Carlos III
Pabellón 11, Planta 0
C/ Monforte de Lemos 3-5
28029 Madrid
Tel. +34 91 171 8114

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:

  • 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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