Xyrem

RSS

sodium oxybate

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 20/08/2018

Authorisation details

Product details
Name
Xyrem
Agency product number
EMEA/H/C/000593
Active substance
sodium oxybate
International non-proprietary name (INN) or common name
sodium oxybate
Therapeutic area (MeSH)
  • Cataplexy
  • Narcolepsy
Anatomical therapeutic chemical (ATC) code
N07XX04
Publication details
Marketing-authorisation holder
UCB Pharma Ltd
Revision
28
Date of issue of marketing authorisation valid throughout the European Union
13/10/2005
Contact address
208 Bath Road
Slough
Berkshire
SL1 3WE
United Kingdom

Product information

13/08/2018 Xyrem - EMEA/H/C/000593 - PSUSA/00010612/201710

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

OTHER NERVOUS SYSTEM DRUGS

Therapeutic indication

Treatment of narcolepsy with cataplexy in adult patients.

Assessment history

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