This is a summary of the European public assessment report (EPAR) for Xyrem. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xyrem.
Xyrem : EPAR - Medicine overview (PDF/142 KB)
First published: 06/07/2007
Last updated: 23/04/2021
Xyrem : EPAR - Risk-management-plan summary (PDF/387.06 KB) (updated)
First published: 08/01/2021
Last updated: 07/07/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
UCB Pharma Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
208 Bath Road
21/06/2021 Xyrem - EMEA/H/C/000593 - IB/0092
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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