Committee for Medicinal Products for Human Use Post-authorisation Summary of Positive Opinion for XyremInternational Nonproprietary Name (INN): sodium oxybate
LONDON, Jan. 24, 2007-On 24 January 2007 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion** to recommend the variation to the terms of the marketing authorisation for the medicinal product Xyrem. The Marketing Authorisation Holder for this medicinal product is UCB Pharma Ltd.
The CHMP adopted a change to the indication, as follows: “Treatment of narcolepsy with cataplexy in adult patients.”
Detailed conditions for the use of this product will be described in the updated Summary of Product Characteristics (SPC) which will be published in the revised European Public Assessment Report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
For information, the full indication for Xyrem will be as follows***: “Treatment of narcolepsy with cataplexy in adult patients.”
* Summaries of positive opinion are published without prejudice to the Commission Decision, which will normally be issued within 44 days (Type II variations) and 67 days (Annex II applications) from adoption of the Opinion.
** Marketing Authorisation Holders may request a re-examination of any CHMP opinion, provided they notify the EMEA in writing of their intention to request a re-examination within 15 days of receipt of the opinion.
*** The text in bold represents the new or the amended indication.
Posted: January 2007