EU/3/19/2228
Table of contents
About
On 16 December 2019, orphan designation EU/3/19/2228 was granted by the European Commission to Alterity Therapeutics UK Limited, United Kingdom, for 5,7-dichloro-2-((ethylamino)methyl)-8-hydroxy-3-methylquinazolin-4(3H)-one mesilate (also known as PBT434) for the treatment of multiple system atrophy.
The sponsorship was transferred to Pharma Gateway AB, Sweden, in October 2020.
Key facts
Active substance |
5,7-dichloro-2-((ethylamino)methyl)-8-hydroxy-3-methylquinazolin-4(3H)-one mesilate
|
Disease / condition |
Treatment of multiple system atrophy
|
Date of first decision |
16/12/2019
|
Outcome |
Positive
|
EU designation number |
EU/3/19/2228
|
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
Pharma Gateway AB
Johanneslundsvagen 2
Hammarby 194 61
Upplands Vaesby Stockholms Lan
Sweden
E-mail: anna.leitgeb@ndareg.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.