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.

Key facts

Active substance
Three human monoclonal antibodies against the EBOV glycoprotein
Disease / condition
Treatment of Ebola virus disease
Date of decision
25/05/2018
Outcome
Positive
Orphan decision 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 U.C.
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:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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