Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Vimpat   
Auth. number : EU/1/08/470
INN : lacosamide
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N03 - Antiepileptics
Pharmacological subgroup: N03A - Antiepileptics
Chemical subgroup: N03AX - Other antiepileptics
Chemical substance: N03AX18 - Lacosamide
(See WHO ATC Index)
Indication: Adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent (16-18 years) patients with epilepsy.
Marketing Authorisation Holder: UCB Pharma S.A.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

  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
02/09/2008 Centralised - Authorisation EMEA/H/C/863 (2008)4783 of 29/08/2008
19/12/2008 Centralised - Variation EMEA/H/C/863/IA/3
16/01/2009 Centralised - Variation EMEA/H/C/863/IB/2
Updated with Decision(2009)6073 of 24/07/2009
04/02/2009 Centralised - Variation EMEA/H/C/863/II/1 (2009)730 of 02/02/2009
31/07/2009 Centralised - Variation EMEA/H/C/863/II/4 (2009)6073 of 24/07/2009
28/12/2009 Centralised - Variation EMEA/H/C/863/II/7 (2009)10705 of 21/12/2009
29/04/2010 Centralised - Variation EMEA/H/C/863/II/9 (2010)2835 of 27/04/2010
20/05/2010 Centralised - Variation EMEA/H/C/863/IA/10/G
Updated with Decision(2010)6224 of 06/09/2010
07/06/2010 Centralised - Variation EMEA/H/C/863/II/8 (2010)3651 of 02/06/2010
05/07/2010 Centralised - Variation EMEA/H/C/863/IA/14/G
Updated with Decision(2010)6224 of 06/09/2010
08/09/2010 Centralised - Variation EMEA/H/C/863/II/13 (2010)6224 of 06/09/2010
27/10/2010 Centralised - Variation EMEA/H/C/863/II/11, 12 (2010)7532 of 25/10/2010
27/01/2011 Centralised - Variation EMEA/H/C/863/IB/16
Updated with Decision(2011)3236 of 06/05/2011
24/02/2011 Centralised - Variation EMEA/H/C/863/IA/18
18/04/2011 Centralised - Variation EMEA/H/C/863/IB/19
12/05/2011 Centralised - Variation EMEA/H/C/863/II/17/G (2011)3236 of 06/05/2011
16/09/2011 Centralised - Variation EMEA/H/C/863/IA/28/G
Updated with Decision(2012)1266 of 21/02/2012
29/11/2011 Referral EMEA/H/C/863/A-20/26 (2011)8858 of 24/11/2011
23/02/2012 Centralised - Variation EMEA/H/C/863/X/27 (2012)1266 of 21/02/2012
22/03/2012 Centralised - Variation EMEA/H/C/863/II/31 (2012)1928 of 19/03/2012
05/06/2012 Centralised - Variation EMEA/H/C/863/IB/34
Updated with Decision(2012)7657 of 24/10/2012
31/07/2012 Centralised - Variation EMEA/H/C/863/IB/36
Updated with Decision(2012)7657 of 24/10/2012
29/10/2012 Centralised - Variation EMEA/H/C/863/II/37 (2012)7657 of 24/10/2012
27/11/2012 Centralised - Variation EMEA/H/C/863/II/32 (2012)8708 of 22/11/2012
12/12/2012 Centralised - Variation
Updated with Decision(2013)5136 of 31/07/2013
05/08/2013 Centralised - Renewal EMEA/H/C/863/R/41 (2013)5136 of 31/07/2013
20/02/2014 Centralised - Variation EMEA/H/C/863/II/44
20/03/2014 Centralised - Variation EMEA/H/C/863//II/45
25/04/2014 Centralised - Variation EMEA/H/C/863/II/46