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.

Key facts

Active substance
Disease / condition
Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma
Date of first decision
EU designation number

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

Acerta Pharma BV
Kloosterstraat 9
5349 AB Oss
The Netherlands
Tel. +31 4127 00576

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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