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)
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
23/09/2021 Xyrem - EMEA/H/C/000593 - II/0093
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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