EU/3/19/2167: Orphan designation for the treatment of lymphoplasmacytic lymphoma

Zanubrutinib

Overview

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Please note that this product (marketed as Brukinsa) was withdrawn from the Union Register of orphan medicinal products in October 2021 upon request of the marketing authorisation holder at the time of the granting of a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.

Key facts

Active substance
Zanubrutinib
Intented use
Treatment of lymphoplasmacytic lymphoma
Orphan designation status
Withdrawn
EU designation number
EU/3/19/2167
Date of designation
29/05/2019
Sponsor

BeiGene Ireland Limited
10 Earlsfort Terrace
Dublin 2 
D02 T380
Ireland
Tel. +353 5667 660
E-mail: bg.ireland@beigene.com
 

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 PDF icon withdrawal assessment report – orphan maintenance .

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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