EU/3/16/1624

About

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Please note that this product (marketed as Calquence ) was withdrawn from the Union Register of orphan medicinal products in September 2020 upon request of the marketing authorisation holder at the time of the granting of a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
Disease / condition
Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma
Date of first decision
21/03/2016
Outcome
Withdrawn
EU designation number
EU/3/16/1624

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 iconwithdrawal assessment report – orphan maintenance .

Sponsor's contact details

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

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.

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