EU/3/13/1157: Orphan designation for the treatment of follicular lymphoma
Table of contents
On 17 July 2013, orphan designation (EU/3/13/1157) was granted by the European Commission to Voisin Consulting SARL, France, for S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one for the treatment of follicular lymphoma.
The sponsorship was transferred to Abbvie Ltd, United Kingdom, in November 2015, then to Voisin Consulting S.A.R.L., France, in September 2016 and finally to Verastem Europe GmbH, Germany, in November 2019.
Please note that this product (marketed as Copiktra) was withdrawn from the Union Register of orphan medicinal products in March 2021 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.
Treatment of follicular lymphoma
|Orphan designation status||
|EU designation number||
|Date of designation||
Verastem Europe GmbH
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one at the time of marketing authorisation.
The sponsor formally requested the withdrawal of the orphan designation prior to the Committee’s final opinion. More information is available in the withdrawal assessment report – orphan maintenance.
Documents related to this orphan designation evaluation
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: