EU/3/06/375: Orphan designation for the treatment of chronic myeloid leukaemia


Table of contents


Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in November 2019 at the end of the 12-year period of market exclusivity.

On 22 May 2006, orphan designation (EU/3/06/375) was granted by the European Commission to Novartis Europharm Limited, United Kingdom, for nilotinib for the treatment of chronic myeloid leukaemia.

Nilotinib has been authorised in the EU as Tasigna since 19 November 2007.

The sponsorship was transferred to Novartis Europharm Limited, Ireland, in May 2018.

Key facts

Active substance
Medicine name
Intended use
Treatment of chronic myeloid leukaemia
Orphan designation status
EU designation number
Date of designation
Novartis Europharm Limited
Vista Building
Elm Park
Merrion Road
Dublin 4
Tel. +41 61 324 11 11 (Switzerland)

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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