This product was withdrawn from the Community Register of designated orphan medicinal products in January 2010 on request of the sponsor.
On 3 February 2003, orphan designation (EU/3/02/131) was granted by the European Commission to IDIS Limited, United Kingdom, for sodium oxybate for the treatment of narcolepsy. The sponsorship was tranferred to Celltech Pharmaceuticals Limited, United Kingdom in February 2004. Celltech Pharmaceuticals Limited subsequently changed name to UCB Pharma Limited.
Sodium oxybate has been authorised in the EU as Xyrem since 13 October 2005.
|Disease / condition||
Treatment of narcolepsy
|Date of decision||
|Orphan decision number||
Sponsor's contact details
208 Bath Road
Telephone: +44 17 53 53 46 55
Telefax: +44 17 53 53 66 32
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;
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.