EU/3/13/1203: Orphan designation for the treatment of diffuse large B-cell lymphoma



Please note that this product was withdrawn from the Union Register of orphan medicinal products in October 2021 on request of the sponsor.

On 13 November 2013, orphan designation (EU/3/13/1203) was granted by the European Commission to Janssen-Cilag International N.V., Belgium, for ibrutinib for the treatment of diffuse large B-cell lymphoma.

Key facts

Active substance
Intended use
Treatment of diffuse large B-cell lymphoma
Orphan designation status
EU designation number
Date of designation

Janssen-Cilag International N.V.
Turnhoutseweg, 30
2340 Beerse
Tel. +32 146 031 89
Fax +32 146 055 33

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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