EU/3/16/1654
Table of contents
About
On 28 April 2016, orphan designation (EU/3/16/1654) was granted by the European Commission to Acies Bio d.o.o., Slovenia, for S-acetyl-(S)-4'-phosphopantetheine, calcium salt for the treatment of pantothenate-kinase-associated neurodegeneration.
The sponsorship was transferred to TM3 Therapeutics B.V., The Netherlands, in September 2018.
The sponsor’s name was updated in July 2019.
Key facts
Active substance |
S-acetyl-(S)-4'-phosphopantetheine, calcium salt
|
Disease / condition |
Treatment of pantothenate-kinase-associated neurodegeneration
|
Date of first decision |
28/04/2016
|
Outcome |
Positive
|
EU designation number |
EU/3/16/1654
|
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
Comet Therapeutics
Galileiweg 8
2333 BD Leiden
The Netherlands
E-mail: info@comettherapeutics.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.