Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Xyrem   
Auth. number : EU/1/05/312
Active substance : Sodium oxybate
Orphan market exclusivity for "Treatment of narcolepsy" (based on designation EU/3/02/131) started on 18/10/2005
   10 years of market exclusivity
   This orphan market exclusivity has ended on 11/01/2010
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N07 - Other nervous system drugs
Pharmacological subgroup: N07X - Other nervous system drugs
Chemical subgroup: N07XX - Other nervous system drugs
Chemical substance: N07XX04 - Hydroxybutyric acid
(See WHO ATC Index)
Indication: Treatment of cataplexy in adult patients with narcolepsy
Marketing Authorisation Holder: UCB Pharma Ltd
208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
18/10/2005 Centralised - Authorisation EMEA/H/C/593 (2005)4087 of 13/10/2005
20/06/2006 Centralised - Variation EMEA/H/C/593/IA/2
Updated with Decision(2007)369 of 01/02/2007
04/09/2006 Centralised - Notification EMEA/H/C/593/N/3
Updated with Decision(2007)369 of 01/02/2007
10/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/593/IA/4
05/02/2007 Centralised - Variation (2007)369 of 01/02/2007
23/02/2007 Centralised - Variation EMEA/H/C/593/IA/5
Updated with Decision(2007)4390 of 18/09/2007
05/03/2007 Centralised - Variation EMEA/H/C/593/II/1 (2007)763 of 01/03/2007
21/06/2007 Centralised - Notification EMEA/H/C/593/N/6
Updated with Decision(2007)4390 of 18/09/2007
20/09/2007 Centralised - Variation (2007)4390 of 18/09/2007
12/10/2007 Centralised - Variation EMEA/H/C/593/IA/9
Updated with Decision(2008)2511 of 02/06/2008
07/11/2007 Centralised - Variation EMEA/H/C/593/II/7 (2007)5424 of 31/10/2007
19/02/2008 Centralised - Notification EMEA/H/C/593/N/11
Updated with Decision(2008)2511 of 02/06/2008
28/03/2008 Centralised - Variation EMEA/H/C/593/IA/13
Updated with Decision(2008)2511 of 02/06/2008
28/05/2008 Centralised - Variation EMEA/H/C/593/IA/14
Updated with Decision(2009)84 of 09/01/2009
04/06/2008 Centralised - Variation (2008)2511 of 02/06/2008
29/07/2008 Centralised - Variation EMEA/H/C/593/IA/18
Updated with Decision(2009)84 of 09/01/2009
21/11/2008 Centralised - Notification EMEA/H/C/593/N/19
Updated with Decision(2009)84 of 09/01/2009
13/01/2009 Centralised - Variation (2009)84 of 09/01/2009
13/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/593/IB/20
04/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/593/IB/21
05/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/593/IB/22
21/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/593/IA/23
19/10/2009 Centralised - Notification EMEA/H/C/593/N/24
Updated with Decision(2010)4701 of 02/07/2010
11/01/2010 Centralised - (orphan status)
12/04/2010 Centralised - Variation EMEA/H/C/593/IA/25
Updated with Decision(2010)4701 of 02/07/2010
06/07/2010 Centralised - Variation (2010)4701 of 02/07/2010
21/09/2010 Centralised - Renewal EMEA/H/C/593/R/27 (2010)6480 of 17/09/2010
04/11/2010 Centralised - Variation EMEA/H/C/593/IB/29
Updated with Decision(2011)1919 of 18/03/2011
21/01/2011 Centralised - Variation EMEA/H/C/593/IB/30/G
Updated with Decision(2011)1919 of 18/03/2011
23/03/2011 Centralised - Variation (2011)1919 of 18/03/2011
21/04/2011 Centralised - Variation EMEA/H/C/593/II/26 (2011)2851 of 18/04/2011
10/11/2011 Centralised - Variation EMEA/H/C/593/IA/35
Updated with Decision(2012)648 of 31/01/2012
02/02/2012 Centralised - Variation (2012)648 of 31/01/2012
01/07/2014 Centralised - 2-Monthly update EMEA/H/C/593/II/50 (2014)4496 of 27/06/2014
20/11/2014 Centralised - Variation EMEA/H/C/593/II/51
Updated with Decision(2015)6270 of 08/09/2015
20/11/2014 Centralised - Variation EMEA/H/C/593/II/52
Updated with Decision(2015)6270 of 08/09/2015
10/09/2015 Centralised - Renewal EMEA/H/C/593/PSUSA/2757/201410, EMEA/H/C/593/R/54 (2015)6270 of 08/09/2015