EU/3/13/1157:

(S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one

Overview

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Please note that this product (marketed as Copiktra) was withdrawn from the Union Register of orphan medicinal products in March 2021 upon request of the marketing authorisation holder at the time of the granting of a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.

Key facts

Active substance
(S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one
Intented use
Treatment of follicular lymphoma
Date of designation
17/07/2013
Orphan designation status
Positive
EU designation number
EU/3/13/1157

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.

Sponsor's contact details

Verastem Europe GmbH
Lange Strasse 70
Walsrode
Lower Saxony 29664
Germany

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.

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