EU/3/13/1160: Orphan designation for the treatment of lymphoplasmacytic lymphoma

Idelalisib

Overview

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in October 2013 on request of the sponsor.

On 17 July 2013, orphan designation (EU/3/13/1160) was granted by the European Commission to Gilead Sciences International Ltd, United Kingdom, for idelalisib for the treatment of lymphoplasmacytic lymphoma.

For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.

Key facts

Active substance
Idelalisib
Intented use
Treatment of lymphoplasmacytic lymphoma
Orphan designation status
Withdrawn
EU designation number
EU/3/13/1160
Date of designation
17/07/2013
Sponsor
Gilead Sciences International Limited
Flowers Building
Granta Park
Abington
Cambridge
CB21 6GT
United Kingdom
Tel. +44 (0)1223 897300
Fax +44 (0)1223 897284
E-mail: regulatory.orphan@gilead.com

Review of designation

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in October 2013 on request of the sponsor, before a marketing authorisation had been granted.

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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