Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Inovelon   
Auth. number : EU/1/06/378
Active substance : Rufinamide
Orphan market exclusivity for "Treatment of Lennox-Gastaut syndrome" (based on designation EU/3/04/240) started on 18/01/2007
   10 years of market exclusivity
   2 additional years of market exclusivity as paediatric reward granted on 13/01/2017
   This orphan market exclusivity will expire on 18/01/2019
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N03 - Antiepileptics
Pharmacological subgroup: N03A - Antiepileptics
Chemical subgroup: N03AF - Carboxamide derivatives
Chemical substance: N03AF03 - Rufinamide
(See WHO ATC Index)
Indication: adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 4 years and older.
Marketing Authorisation Holder: Eisai Limited
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, 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
18/01/2007 Centralised - Authorisation EMEA/H/C/660 (2007)177 of 16/01/2007
23/02/2007 Corrigendum EMEA/H/C/660 (2007)177 cor of 21/02/2007
16/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/660/IB/1
16/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/660/IB/2
10/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/660/IA/4
28/08/2007 Centralised - Variation EMEA/H/C/660/II/3 (2007)4048 of 23/08/2007
18/01/2008 Centralised - Variation EMEA/H/C/660/IA/5
Updated with Decision(2008)1385 of 08/04/2008
18/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/660/IA/6
15/02/2008 Corrigendum EMEA/H/C/660/II/3 (2007)4048 of 13/02/2008
28/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/660/IA/8
10/04/2008 Centralised - Variation EMEA/H/C/660/II/7 (2008)1385 of 08/04/2008
03/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/660/IA/9
19/01/2009 Centralised - Notification EMEA/H/C/660/N/10
Updated with Decision(2009)6826 of 02/09/2009
12/02/2009 Centralised - Variation EMEA/H/C/660/IA/11
Updated with Decision(2009)6826 of 02/09/2009
18/03/2009 Centralised - Variation EMEA/H/C/660/IA/12
Updated with Decision(2009)6826 of 02/09/2009
05/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/660/IA/14
07/08/2009 Centralised - Notification EMEA/H/C/660/N/13
Updated with Decision(2009)6826 of 02/09/2009
07/09/2009 Centralised - Variation (2009)6826 of 02/09/2009
23/10/2009 Centralised - Variation EMEA/H/C/660/IB/15
Updated with Decision(2010)1658 of 11/03/2010
15/03/2010 Centralised - Variation (2010)1658 of 11/03/2010
11/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/660/IB/16
25/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/660/IA/18/G
10/05/2011 Centralised - Notification EMEA/H/C/660/N/19
Updated with Decision(2011)8643 of 21/11/2011
23/11/2011 Centralised - Variation EMEA/H/C/660/X/17 (2011)8643 of 21/11/2011
11/01/2012 Centralised - Renewal EMEA/H/C/660/R/20 (2012)95 of 09/01/2012
15/11/2012 Centralised - Variation EMEA/H/C/660/II/25
Updated with Decision(2013)9478 of 13/12/2013
28/06/2013 Centralised - Variation EMEA/H/C/660/IB/27
Updated with Decision(2013)9478 of 13/12/2013
17/12/2013 Centralised - Yearly update (2013)9478 of 13/12/2013
13/01/2017 Centralised - 2-Monthly update EMEA/H/C/660/II/37 (2017)172 of 11/01/2017
21/04/2017 Centralised - Notification EMEA/H/C/660/N/44