EU/3/16/1624: Orphan designation for the treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma

Acalabrutinib

Overview

On 21 March 2016, orphan designation (EU/3/16/1624) was granted by the European Commission to Acerta Pharma, BV, the Netherlands, for acalabrutinib for the treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma.

The sponsorship was transferred to AstraZeneca AB, Sweden, in October 2019.

Please note that this product (marketed as Calquence ) was withdrawn from the Union Register of orphan medicinal products in September 2020 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

Key facts

Active substance
Acalabrutinib
Intended use
Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma
Orphan designation status
Withdrawn
EU designation number
EU/3/16/1624
Date of designation
21/03/2016
Sponsor

AstraZeneca AB 
51 85
Södertälje
Sweden
Tel: +46(0)733542209
E-mail: victoria.lindfelt-eriksson@astrazeneca.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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