EU/3/13/1187: Orphan designation for the treatment of splenic marginal-zone lymphoma
Idelalisib
Table of contents
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Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in October 2013 on request of the sponsor.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 5 August 2013, orphan designation (EU/3/13/1187) was granted by the European Commission to Gilead Sciences International Ltd, United Kingdom, for idelalisib for the treatment of splenic marginal-zone 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
|
Intended use |
Treatment of splenic marginal-zone lymphoma
|
Orphan designation status |
Withdrawn
|
EU designation number |
EU/3/13/1187
|
Date of designation |
05/08/2013
|
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Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in October 2013 on request of the sponsor, before a marketing authorisation had been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.
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: