EU/3/05/339: Orphan designation for the treatment of chronic myeloid leukaemia

dasatinib

Table of contents

Overview

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in November 2016 at the end of the period of market exclusivity.

On 23 December 2005, orphan designation (EU/3/05/339) was granted by the European Commission to Bristol-Myers Squibb Pharma EEIG, United Kingdom, for dasatinib for the treatment of chronic myeloid leukaemia.

Dasatinib has been authorised in the EU as Sprycel since 20 November 2006.

Key facts

Active substance
dasatinib
Medicine name
Sprycel
Intended use
Treatment of chronic myeloid leukaemia
Orphan designation status
Expired
EU designation number
EU/3/05/339
Date of designation
23/12/2005
Sponsor
Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom
Tel. +44 (0)1895 523740
Fax +44 (0)1895 523677
E-mail: medical.information@bms.com

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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