EU/3/20/2386: Orphan designation for the treatment of idiopathic hypersomnia
sodium oxybate / calcium oxybate / magnesium oxybate / potassium oxybate
Table of contents
On 6 January 2021, orphan designation EU/3/20/2386 was granted by the European Commission to Jazz Pharmaceuticals Ireland Limited, Ireland, for calcium oxybate, magnesium oxybate, potassium oxybate, sodium oxybate (also known as JZP-258) for the treatment of idiopathic hypersomnia.
Treatment of idiopathic hypersomnia
|Orphan designation status||
|EU designation number||
|Date of designation||
Jazz Pharmaceuticals Ireland Ltd
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
Documents related to this orphan designation evaluation
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: