EU/3/15/1434:

Chimeric group B adenovirus (11p/3) with deletions in the E3 and E4 regions (enadenotucirev)

Overview

On 12 February 2015, orphan designation (EU/3/15/1434) was granted by the European Commission to PsiOxus Therapeutics Ltd, United Kingdom, for chimeric group B adenovirus (11p/3) with deletions in the E3 and E4 regions for the treatment of ovarian cancer.

This medicine is now known as enadenotucirev.

The sponsorship was transferred to Regulis Consulting Europe Limited, Ireland, in April 2019.

Please note that this product was withdrawn form the Union Register of orphan medicinal products in June 2021 on request of the Sponsor.

Key facts

Active substance
Chimeric group B adenovirus (11p/3) with deletions in the E3 and E4 regions (enadenotucirev)
Intented use
Treatment of ovarian cancer
Orphan designation status
Withdrawn
EU designation number
EU/3/15/1434
Date of designation
12/02/2015
Sponsor

Regulis Consulting Europe Limited
The Black Church
Saint Mary's Place
Dublin 7 DO7 P4AX
Ireland
Tel: +353 1 231 4691
E-mail: enquiries@regulis.com

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Documents related to this orphan designation evaluation

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.

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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