EU/3/18/1993: Orphan designation for the treatment of neuronal ceroid lipofuscinosis
Table of contents
On 21 March 2018, orphan designation (EU/3/18/1993) was granted by the European Commission to Quintiles Ireland Limited, Ireland, for gemfibrozil for the treatment of neuronal ceroid lipofuscinosis.
In May 2018, Quintiles Ireland Limited changed name to IQVIA RDS Ireland Limited.
The sponsorship was transferred to Premier Research Group S.L., Spain, in May 2019.
Treatment of neuronal ceroid lipofuscinosis
|Orphan designation status||
|EU designation number||
|Date of designation||
Premier Research Group S.L.
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
Documents related to this orphan designation evaluation
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.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: