EU/3/18/2027

About

On 25 May 2018, orphan designation (EU/3/18/2027) was granted by the European Commission to Regeneron Ireland U.C., Ireland, for three human monoclonal antibodies against the EBOV glycoprotein (also known as REGN3470-3471-3479) for the treatment of Ebola virus disease.

In December 2019, Regeneron Ireland U.C. changed name to Regeneron Ireland DAC.

Key facts

Active substance
Three human monoclonal antibodies against the EBOV glycoprotein
Disease / condition
Treatment of Ebola virus disease
Date of first decision
25/05/2018
Outcome
Positive
EU designation number
EU/3/18/2027

Review of designation

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

Sponsor's contact details

Regeneron Ireland DAC
Europa House
Harcourt Centre
Harcourt Street
Dublin 2
Ireland
Tel. +353 (0)1 411 2200
E-mail: eu-regaffairs@regeneron.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.

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