EU/3/16/1625: Orphan designation for the treatment of mantle cell lymphoma



On 21 March 2016, orphan designation (EU/3/16/1625) was granted by the European Commission to Acerta Pharma, BV, the Netherlands, for acalabrutinib for the treatment of mantle cell lymphoma.

Key facts

Active substance
Intended use
Treatment of mantle cell lymphoma
Orphan designation status
EU designation number
Date of designation
Acerta Pharma, BV
Kloosterstraat 9
5349 AB Oss
The Netherlands
Tel. +31 4127 00576

Review of designation

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

Documents related to this orphan designation evaluation

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.

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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