EU/3/19/2224
Table of contents
About
On 13 November 2019, orphan designation EU/3/19/2224 was granted by the European Commission to Pharma Gateway AB, Sweden, for ganaxolone for the treatment of CDKL5 deficiency disorder.
Key facts
Active substance |
Ganaxolone
|
Disease / condition |
Treatment of CDKL5 deficiency disorder
|
Date of first decision |
13/11/2019
|
Outcome |
Positive
|
EU designation number |
EU/3/19/2224
|
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product it it is approved for marketing authorisation.
Sponsor's contact details
Pharma Gateway AB
Johanneslundsvägen 2
Hammarby
194 61 Upplands Väsby
Stockholms Lan
Sweden
Tel. +46 8 590 778 00
E-mail: info@pharmagateway.eu
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.