Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zebinix   
Auth. number : EU/1/09/514
INN : eslicarbazepine acetate
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N03 - Antiepileptics
Pharmacological subgroup: N03A - Antiepileptics
Chemical subgroup: N03AF - Carboxamide derivatives
Chemical substance: N03AF04 - Eslicarbazepine
(See WHO ATC Index)
Indication: Adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.
Marketing Authorisation Holder: BIAL - Portela & Ca, SA
A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal

  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
23/04/2009 Centralised - Authorisation EMEA/H/C/988 (2009)3128 of 21/04/2009
18/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/988/IA/14
18/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/988/IA/2
19/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/988/IA/2
19/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/988/IA/10
19/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/988/IA/1
19/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/988/IA/8
19/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/988/IA/11
19/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/988/IA/12
19/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/988/IA/9
19/05/2009 Centralised - Variation EMEA/H/C/988/IA/13
Updated with Decision(2009)10395 of 14/12/2009
05/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/988/IB/3
05/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/988/IB/6
05/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/988/IB/4
05/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/988/IB/7
05/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/988/IB/5
28/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/988/IA/15
19/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/988/IB/16
17/12/2009 Centralised - Variation (2009)10395 of 14/12/2009
04/02/2010 Centralised - Notification EMEA/H/C/988/N/17
Updated with Decision(2012)6030 of 23/08/2012
28/10/2010 Centralised - Variation EMEA/H/C/988/IB/19
Updated with Decision(2011)4397 of 16/06/2011
29/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/988/IA/20/G
02/12/2010 Centralised - Variation EMEA/H/C/988/II/18/G (2010)8639 of 29/11/2010
03/05/2011 Centralised - Variation EMEA/H/C/988/IA/21/G
Updated with Decision(2011)4397 of 16/06/2011
21/06/2011 Centralised - Variation (2011)4397 of 16/06/2011
15/11/2011 Centralised - Variation EMEA/H/C/988/WS/162 (2011)8242 of 10/11/2011
10/02/2012 Centralised - Variation EMEA/H/C/988/IB/27
Updated with Decision(2012)6030 of 23/08/2012
22/06/2012 Centralised - Variation EMEA/H/C/988/IB/30
Updated with Decision(2012)6030 of 23/08/2012
27/08/2012 Centralised - Variation EMEA/H/C/988/WS/258 (2012)6030 of 23/08/2012
27/08/2012 Centralised - Variation EMEA/H/C/988/X/24 (2012)6034 of 23/08/2012
17/01/2013 Centralised - 2-Monthly update EMEA/H/C/988/IB/32/G (2013)209 of 14/01/2013
15/04/2013 Centralised - Variation EMEA/H/C/988/IB/36
Updated with Decision(2014)419 of 22/01/2014
24/01/2014 Centralised - Renewal EMEA/H/C/988/R/40 (2014)419 of 22/01/2014
20/03/2014 Centralised - Variation EMEA/H/C/988/II/35
25/09/2014 Centralised - Variation EMEA/H/C/988/II/44