EU/3/12/1072

About

On 8 November 2012, orphan designation (EU/3/12/1072) was granted by the European Commission to Enpharma Ltd, United Kingdom, for encapsulated human retinal pigment epithelial cell line transfected with plasmid vector expressing human ciliary neurotropic factor for the treatment of macular telangiectasia type 2.

The sponsorship was transferred to Le4D Limited, United Kingdom, in March 2018.

The sponsorship was transferred to Le4d Global Regulatory Science Limited, Ireland, in November 2019.

Key facts

Active substance
Encapsulated human retinal pigment epithelial cell line transfected with plasmid vector expressing human ciliary neurotropic factor
Disease / condition
Treatment of macular telangiectasia type 2
Date of first decision
08/11/2012
Outcome
Positive
EU designation number
EU/3/12/1072

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

Le4d Global Regulatory Science Limited
1st Floor
6 Lapp's Quay
Cork T12 VY7W
Co. Cork
Ireland
Tel: +353872422354
E-mail: zubair.le4d@hotmail.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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