EU/3/13/1187

About

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in October 2013 on request of the sponsor.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
Disease / condition
Treatment of splenic marginal-zone lymphoma
Date of first decision
05/08/2013
Outcome
Withdrawn
EU designation number
EU/3/13/1187

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Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in October 2013 on request of the sponsor, before a marketing authorisation had been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

Sponsor's contact details

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

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.

How useful was this page?

Add your rating