EU/3/18/2072
Table of contents
About
On 26 October 2018, orphan designation (EU/3/18/2072) was granted by the European Commission to FGK Representative Service GmbH, Germany, for 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate (also known as ELX-02) for the treatment of cystic fibrosis.
The sponsorship was transferred to TMC Pharma (EU) Limited, Ireland, in October 2020.
Key facts
Active substance |
6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate
|
Disease / condition |
Treatment of cystic fibrosis
|
Date of first decision |
26/10/2018
|
Outcome |
Positive
|
EU designation number |
EU/3/18/2072
|
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
TMC Pharma (EU) Limited
The Black Church
St. Mary's Place
Dublin D07 P4AX
Ireland
Tel. +353 76 670 5745
E-mail: regulatory.services@tmcpharma.com
Patients' organisations
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.