European Commission
Public Health
Accessibility tools
Service tools
Language selector
- Current languageen
Navigation path
Community Register of medicinal products
Community register of medicinal products for human use
Product information
| Invented name: | Vimpat |
| INN : | lacosamide |
| ATC: | N - Nervous system N03 - Antiepileptics N03A - Antiepileptics N03AX - Other antiepileptics N03AX18 - Lacosamide (See WHO ATC Index) |
| Indication: | Vimpat is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. |
| Marketing Authorisation Holder: | UCB Pharma SA. |
Package presentations
| EU Number | Presentation | Authorisation date |
| EU/1/08/470/001 | Vimpat - 50 mg - Film-coated tablet - Oral use - Blister (PVC/PVDC/alu) - 14 tablets | 29 Aug 2008 |
| EU/1/08/470/002 | Vimpat - 50 mg - Film-coated tablet - Oral use - Blister (PVC/PVDC/alu) - 56 tablets | 29 Aug 2008 |
| EU/1/08/470/003 | Vimpat - 50 mg - Film-coated tablet - Oral use - Blister (PVC/PVDC/alu) - 168 tablets | 29 Aug 2008 |
| EU/1/08/470/004 | Vimpat - 100 mg - Film-coated tablet - Oral use - Blister (PVC/PVDC/alu) - 14 tablets | 29 Aug 2008 |
| EU/1/08/470/005 | Vimpat - 100 mg - Film-coated tablet - Oral use - Blister (PVC/PVDC/alu) - 56 tablets | 29 Aug 2008 |
| EU/1/08/470/006 | Vimpat - 100 mg - Film-coated tablet - Oral use - Blister (PVC/PVDC/alu) - 168 tablets | 29 Aug 2008 |
| EU/1/08/470/007 | Vimpat - 150 mg - Film-coated tablet - Oral use - Blister (PVC/PVDC/alu) - 14 tablets | 29 Aug 2008 |
| EU/1/08/470/008 | Vimpat - 150 mg - Film-coated tablet - Oral use - Blister (PVC/PVDC/alu) - 56 tablets | 29 Aug 2008 |
| EU/1/08/470/009 | Vimpat - 150 mg - Film-coated tablet - Oral use - Blister (PVC/PVDC/alu) - 168 tablets | 29 Aug 2008 |
| EU/1/08/470/010 | Vimpat - 200 mg - Film-coated tablet - Oral use - Blister (PVC/PVDC/alu) - 14 tablets | 29 Aug 2008 |
| EU/1/08/470/011 | Vimpat - 200 mg - Film-coated tablet - Oral use - Blister (PVC/PVDC/alu) - 56 tablets | 29 Aug 2008 |
| EU/1/08/470/012 | Vimpat - 200 mg - Film-coated tablet - Oral use - Blister (PVC/PVDC/alu) - 168 tablets | 29 Aug 2008 |
| EU/1/08/470/013 | Vimpat - 50/100/150/200 mg - Film-coated tablet - Oral use - Blister (PVC/PVDC/alu) - Treatment initiation pack: 14 tablets + 14 tablets + 14 tablets + 14 tablets | 29 Aug 2008 |
| EU/1/08/470/014 | Vimpat - 15 mg/ml - Syrup - Oral use - Bottle (glass or PET) - 200 ml - 1 bottle | WithDrawn |
| EU/1/08/470/015 | Vimpat - 15 mg/ml - Syrup - Oral use - Bottle (glass or PET) - 465 ml - 1 bottle | WithDrawn |
| EU/1/08/470/016 | Vimpat - 10 mg/ml - Solution for infusion - Intravenous use - Vial (glass) - 20 ml - 1 vial | 29 Aug 2008 |
| EU/1/08/470/017 | Vimpat - 10 mg/ml - Solution for infusion - Intravenous use - Vial (glass) - 20 ml - 5 vials | 16 Jan 2009 |
| EU/1/08/470/018 | Vimpat - 10 mg/ml - Syrup - Oral use - bottle (glass) - 200 ml - 1 bottle | 21 Feb 2012 |
| EU/1/08/470/019 | Vimpat - 10 mg/ml - Syrup - Oral use - bottle (glass) - 465 ml - 1 bottle | 21 Feb 2012 |
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 2/09/2008 | Centralised - Authorisation | EMEA/H/C/863 | C(2008)4783 of 29/08/2008 | |||
| 19/12/2008 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/863/IA/3 | ||||
| 16/01/2009 | Centralised - Variation Type IB - (Acceptance modification) | EMEA/H/C/863/IB/2 | ||||
| Updated with Decision C(2009)6073 of 24/07/2009 |
|
|||||
| 4/02/2009 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/863/II/1 | C(2009)730 of 2/02/2009 | |||
| 31/07/2009 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/863/II/4 | C(2009)6073 of 24/07/2009 | |||
| 28/12/2009 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/863/II/7 | C(2009)10705 of 21/12/2009 | |||
| 29/04/2010 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/863/II/9 | C(2010)2835 of 27/04/2010 | |||
| 20/05/2010 | Centralised - Variation Type IAin - (Acceptance modification) | EMEA/H/C/863/IA/10/G | ||||
| Updated with Decision C(2010)6224 of 6/09/2010 |
|
|||||
| 7/06/2010 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/863/II/8 | C(2010)3651 of 2/06/2010 | |||
| 5/07/2010 | Centralised - Variation Type IA - (Non-immediate notification) | EMEA/H/C/863/IA/14/G | ||||
| Updated with Decision C(2010)6224 of 6/09/2010 |
|
|||||
| 8/09/2010 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/863/II/13 | C(2010)6224 of 6/09/2010 | |||
| 27/10/2010 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/863/II/11, 12 | C(2010)7532 of 25/10/2010 | |||
| 27/01/2011 | Centralised - Variation Type IB - (Acceptance modification) | EMEA/H/C/863/IB/16 | ||||
| Updated with Decision C(2011)3236 of 6/05/2011 |
|
|||||
| 24/02/2011 | Centralised - Variation Type IA - (No change in original decision or annexes)
|
EMEA/H/C/863/IA/18 | ||||
| 18/04/2011 | Centralised - Variation Type IB - (No change in original decision or annexes)
|
EMEA/H/C/863/IB/19 | ||||
| 12/05/2011 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/863/II/17/G | C(2011)3236 of 6/05/2011 | |||
| 16/09/2011 | Centralised - Variation Type IAin - (Acceptance modification) | EMEA/H/C/863/IA/28/G | ||||
| Updated with Decision C(2012)1266 of 21/02/2012 |
|
|||||
| 29/11/2011 | Centralised - Art. 20 - (Maintain) Title IV | EMEA/H/C/863/A-20/26 | C(2011)8858 of 24/11/2011 | |||
| 23/02/2012 | Centralised - Annex II extension adding new number | EMEA/H/C/863/X/27 | C(2012)1266 of 21/02/2012 | |||
| 22/03/2012 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/863/II/31 | C(2012)1928 of 19/03/2012 |