Refusal of orphan designation for the treatment of uveal melanoma

Enterovirus B, echovirus 7, live

Table of contents

Overview

Enterovirus B, Echovirus 7, live has not been designated as an orphan medicine for the treatment of uveal melanoma in the European Union, despite an application from the sponsor.

Absence of orphan designation does not preclude the development of this medicine, including its use in clinical trials. The medicine can be authorised if its quality, safety and efficacy are demonstrated.

During the medicine's development, doctors may be able to enrol patients in clinical trials investigating the medicine. For information on ongoing clinical trials in the EU, see:

Key facts

Active substance
Enterovirus B, echovirus 7, live
Intended use
Treatment of uveal melanoma
Orphan designation status
Negative
EU designation number
-
Date of refusal of designation
11/01/2022
Sponsor

Latima SIA
Atlasa Iela 7c
Riga 1026
Latvia
Email: rigvir@rigvir.com

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:

How useful was this page?

Add your rating