EU/3/12/1059: Orphan designation for the treatment of malignant thymoma

milciclib maleate


On 8 November 2012, orphan designation (EU/3/12/1059) was granted by the European Commission to Nerviano Medical Science Srl, Italy, for milciclib maleate for the treatment of malignant thymoma.

The sponsorship was transferred to Tiziana Life Sciences PLC, United Kingdom, in November 2015.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in March 2021 on request of the Sponsor.

Key facts

Active substance
milciclib maleate
Intented use
Treatment of malignant thymoma
Orphan designation status
EU designation number
Date of designation
Tiziana Life Sciences PLC
18 South Street
London W1K 1DG
United Kingdom
Tel. +44 (0)20 7493 2853
Fax +44 (0)20 7495 2379

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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