EU/3/17/1933

About

On 12 October 2017, orphan designation (EU/3/17/1933) was granted by the European Commission to Quintiles Ireland Limited, Ireland, for (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione (also known as VCE-004.8 and EHP-101) for the treatment of systemic sclerosis.

In May 2018 the sponsor, Quintiles Ireland Limited changed name to IQVIA RDS Ireland Limited.

The sponsorship was transferred to Emerald Health Pharmaceuticals España, S.L., Spain, in November 2018.

Key facts

Active substance
(1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione
Disease / condition
Treatment of systemic sclerosis
Date of decision
12/10/2017
Outcome
Positive
Orphan decision number
EU/3/17/1933

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

Emerald Health Pharmaceuticals España, S.L.
Parque Científico Tecnológico de Córdoba (Rabanales 21)
C/ Astrónoma Cecilia Payne
Edificio Centauro, Planta 1
14014 Córdoba
Spain
Tel. +34 6487 25447
E-mail: info@emeraldpharma.life

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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