Xyrem

sodium oxybate

Table of contents

Opinion

On 12 November 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Xyrem. The marketing authorisation holder for this medicinal product is UCB Pharma S.A.

The CHMP adopted an extension to the existing indication as follows*:

Treatment of narcolepsy with cataplexy in adult patients, adolescents and children from the age of 7 years.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


* New text in bold

Key facts

Name
Xyrem
Agency product number
EMEA/H/C/000593
International non-proprietary name (INN) or common name
  • sodium oxybate
Active substance
  • sodium oxybate
Therapeutic area
Cataplexy
Narcolepsy
Date opinion adopted
12/11/2020
Company name
UCB Pharma Ltd
Status
Positive
Application type
Post-authorisation

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