EU/3/19/2167: Orphan designation for the treatment of lymphoplasmacytic lymphoma
Table of contents
On 29 May 2019, orphan designation (EU/3/19/2167) was granted by the European Commission to BeiGene Ireland Limited, Ireland, for zanubrutinib, also known as (BGB-3111), for the treatment of lymphoplasmatic lymphoma.
Please note that this product (marketed as Brukinsa) was withdrawn from the Union Register of orphan medicinal products in October 2021 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.
Treatment of lymphoplasmacytic lymphoma
|Orphan designation status||
|EU designation number||
|Date of designation||
BeiGene Ireland Limited
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of product at the time of marketing authorisation.
The sponsor formally requested the withdrawal of the orphan designation prior to the Committee’s final opinion. More information is available in the withdrawal assessment report – orphan maintenance .
Documents related to this orphan designation evaluation
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: