EU/3/15/1550: Orphan designation for the treatment of idiopathic pulmonary fibrosis
3-pentylbenzeneacetic acid sodium salt
Table of contents
Overview
On 9 October 2015, orphan designation (EU/3/15/1550) was granted by the European Commission to ProMetic BioTherapeutics Ltd, United Kingdom, for 3-pentylbenzeneacetic acid sodium salt for the treatment of idiopathic pulmonary fibrosis.
The sponsorship was transferred to ProMetic Pharma SMT Limited, United Kingdom, in June 2016.
The sponsorship was transferred to Prometic Pharma SMT B.V., The Netherlands, in May 2019.
Please note that this product was withdrawn from the Union Register of orphan medicinal products in February 2022 on request of the Sponsor.
Key facts
Active substance |
3-pentylbenzeneacetic acid sodium salt
|
Intended use |
Treatment of idiopathic pulmonary fibrosis
|
Orphan designation status |
Withdrawn
|
EU designation number |
EU/3/15/1550
|
Date of designation |
09/10/2015
|
Sponsor |
Prometic Pharma SMT B.V. |
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
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.
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: