EU/3/16/1665

About

On 30 May 2016, orphan designation (EU/3/16/1665) was granted by the European Commission to TMC Pharma Services Ltd, United Kingdom, for recombinant adeno-associated viral vector containing the human RPGR gene for the treatment of retinitis pigmentosa caused by mutations in the RPGR gene.

The sponsorship was transferred to Diamond Roc EOOD, Bulgaria, in April 2019.

The sponsorship was transferred to Diamond Pharma Services Ireland Limited in February 2020.

Key facts

Active substance
Recombinant adeno-associated viral vector containing the human RPGR gene
Disease / condition
Treatment of retinitis pigmentosa caused by mutations in the RPGR gene
Date of first decision
30/05/2016
Outcome
Positive
EU designation number
EU/3/16/1665

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

Diamond Pharma Services Ireland Limited 
Coliemore House
Coliemore Road
Dalkey
Co. Dublin
Ireland 
Tel. 02039119410
E-mail: mgraham@diamondpharmaservices.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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