EU/3/11/901: Orphan designation for the treatment of chronic lymphocytic leukaemia



On 27 September 2011, orphan designation (EU/3/11/901) was granted by the European Commission to Merck Sharp & Dohme Limited, United Kingdom, for dinaciclib for the treatment of chronic lymphocytic leukaemia.

The sponsorship was transferred to Merck Sharp & Dohme B.V., The Netherlands in October 2018.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in February 2022 on request of the Sponsor.

Key facts

Active substance
Intended use
Treatment of chronic lymphocytic leukaemia
Orphan designation status
EU designation number
Date of designation

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
Tel. +31 2351 53260

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:

  • 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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