Xyrem
sodium oxybate
Table of contents
Overview
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.
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List item
Xyrem : EPAR - Summary for the public (PDF/82.72 KB)
First published: 06/07/2007
Last updated: 17/07/2014 -
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Xyrem : EPAR - Risk-management-plan summary (PDF/331.35 KB)
First published: 08/01/2021
This EPAR was last updated on 08/01/2021
Authorisation details
Product details | |
---|---|
Name |
Xyrem
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Agency product number |
EMEA/H/C/000593
|
Active substance |
sodium oxybate
|
International non-proprietary name (INN) or common name |
sodium oxybate
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
N07XX04
|
Publication details | |
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Marketing-authorisation holder |
UCB Pharma Ltd
|
Revision |
31
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Date of issue of marketing authorisation valid throughout the European Union |
13/10/2005
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Contact address |
Product information
17/12/2020 Xyrem - EMEA/H/C/000593 - II/0076
Contents
- 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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Pharmacotherapeutic group
Pharmacotherapeutic group
Other nervous system drugs
Therapeutic indication
Therapeutic indication
Treatment of narcolepsy with cataplexy in adult patients.