Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


EXPIRED  

Product information

Invented name: Exalief
Auth. number : EU/1/09/520
Active substance : 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
À 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/987 (2009)3127 of 21/04/2009
14/05/2009 Centralised - Variation EMEA/H/C/987/IA/13
Updated with Decision(2009)10394 of 14/12/2009
14/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/987/IA/14
14/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/987/IA/9
14/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/987/IA/1
14/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/987/IA/10
14/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/987/IA/2
14/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/987/IA/12
14/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/987/IA/8
14/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/987/IA/11
05/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/987/IB/7
05/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/987/IB/3
05/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/987/IB/4
05/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/987/IB/6
05/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/987/IB/5
29/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/987/IA/15
19/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/987/IB/16
17/12/2009 Centralised - Variation (2009)10394 of 14/12/2009
28/10/2010 Centralised - Variation EMEA/H/C/987/IB/18
Updated with Decision(2011)3716 of 23/05/2011
29/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/987/IA/19/G
02/12/2010 Centralised - Variation EMEA/H/C/987/II/17/G (2010)8647 of 29/11/2010
15/04/2011 Centralised - Variation EMEA/H/C/987/IA/20/G
Updated with Decision(2011)3716 of 23/05/2011
26/05/2011 Centralised - Variation (2011)3716 of 23/05/2011
04/11/2011 Centralised - Variation EMEA/H/C/987/WS/162 (2011)7943 of 27/10/2011
15/12/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/987/WS/120
10/02/2012 Centralised - Variation EMEA/H/C/987/IB/25
21/04/2012 Centralised - Withdrawal (sunset clause)