Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Keppra   
Auth. number : EU/1/00/146
INN : levetiracetam
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N03 - Antiepileptics
Pharmacological subgroup: N03A - Antiepileptics
Chemical subgroup: N03AX - Other antiepileptics
Chemical substance: N03AX14 - Levetiracetam
(See WHO ATC Index)
Indication: Keppra is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Keppra is indicated as adjunctive therapy:
- in the treatment of partial onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy.
- in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
- in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised 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
11/10/2000 Centralised - Authorisation EMEA/H/C/277 (2000)2786 of 29/09/2000
08/01/2001 Centralised - Variation (no change in Commission Decision)
08/02/2001 Centralised - Variation (no change in Commission Decision)
09/04/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/I/10, 12
02/05/2001 Centralised - Variation EMEA/H/C/277/I/6 (2001)872 of 27/04/2001
03/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/II/1
07/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/II/13
07/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/I/14
18/03/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/I/17
02/04/2002 Centralised - Notification EMEA/H/C/277/N/16 (2002)1322 of 26/03/2002
27/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/I/9
22/07/2002 Centralised - Variation EMEA/H/C/277/II/15 (2002)2837 of 18/07/2002
24/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/I/21
09/10/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/I/22
23/10/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/I/23
30/10/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/I/24
16/01/2003 Centralised - Variation EMEA/H/C/277/II/20 (2003)307 of 14/01/2003
18/02/2003 Centralised - Variation EMEA/H/C/277/I/5 (2003)596 of 14/02/2003
05/03/2003 Centralised - Variation EMEA/H/C/277/X/18 (2003)745 of 03/03/2003
02/05/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/II/26
01/09/2003 Centralised - Variation EMEA/H/C/277/I/27 (2003)3176 of 28/08/2003
16/12/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/II/28
13/01/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/29
09/02/2004 Centralised - Variation EMEA/H/C/277/II/30 (2004)413 of 05/02/2004
09/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/33
26/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/35
26/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/34
26/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/II/32
16/07/2004 Centralised - Variation EMEA/H/C/277/II/31 (2004)2808 of 13/07/2004
20/07/2004 Centralised - Variation EMEA/H/C/277/IB/37
Updated with Decision(2005)383 of 14/02/2005
04/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/II/36
12/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/38
26/11/2004 Centralised - Variation EMEA/H/C/277/IA/40
Updated with Decision(2005)383 of 14/02/2005
07/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/42
20/12/2004 Centralised - Notification EMEA/H/C/277/N/41
Updated with Decision(2005)383 of 14/02/2005
22/12/2004 Centralised - Variation EMEA/H/C/277/IB/39
Updated with Decision(2005)383 of 14/02/2005
16/02/2005 Centralised - Variation (2005)383 of 14/02/2005
29/04/2005 Centralised - Variation EMEA/H/C/277/II/43 (2005)1383 of 27/04/2005
01/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/II/47
03/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/49
05/07/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/51
11/07/2005 Centralised - Renewal EMEA/H/C/277/R/45 (2005)2746 of 08/07/2005
05/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/52
08/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/II/50
19/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/53
30/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/56
12/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/57
16/09/2005 Centralised - Variation EMEA/H/C/277/II/48 (2005)3549 of 13/09/2005
16/09/2005 Centralised - Variation EMEA/H/C/277/II/44 (2005)3548 of 13/09/2005
19/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/55
17/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/60
21/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/59
29/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/62
28/02/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/II/58
31/03/2006 Centralised - Variation EMEA/H/C/277/X/46 (2006)1340 of 29/03/2006
05/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/66
24/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/65
27/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/68
27/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/64
02/05/2006 Centralised - Variation EMEA/H/C/277/II/61 (2006)1796 of 27/04/2006
13/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/72
25/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/75
28/07/2006 Centralised - Variation EMEA/H/C/277/II/70 (2006)3428 of 25/07/2006
09/08/2006 Centralised - Variation EMEA/H/C/277/II/63 (2006)3664 of 07/08/2006
28/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/74
03/11/2006 Centralised - Variation EMEA/H/C/277/II/73 (2006)5334 of 30/10/2006
10/01/2007 Centralised - Variation EMEA/H/C/277/II/71 (2007)37 of 04/01/2007
07/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/77
01/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/II/78
16/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/81
17/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/79
17/04/2007 Centralised - Variation EMEA/H/C/277/IA/82
Updated with Decision(2007)3798 of 01/08/2007
18/04/2007 Centralised - Variation EMEA/H/C/277/IA/80
Updated with Decision(2007)3798 of 01/08/2007
03/08/2007 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/277/T/83 (2007)3798 of 01/08/2007
20/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/89
27/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/87
23/10/2007 Centralised - Variation EMEA/H/C/277/II/84 (2007)5231 of 19/10/2007
23/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/II/88
23/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/II/86
19/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/90
20/12/2007 Centralised - Variation EMEA/H/C/277/IA/91
Updated with Decision(2008)4033 of 24/07/2008
26/12/2007 Centralised - Variation EMEA/H/C/277/II/85 (2007)6866 of 21/12/2007
25/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/92
05/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/93
28/07/2008 Centralised - Variation (2008)4033 of 24/07/2008
29/07/2008 Centralised - Variation EMEA/H/C/277/II/94 (2008)4071 of 25/07/2008
05/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/96
20/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/98
18/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/100
28/01/2009 Centralised - Variation EMEA/H/C/277/II/99 (2009)561 of 26/01/2009
04/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/II/101
09/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/102
07/09/2009 Centralised - Variation EMEA/H/C/277/II/97 (2009)6825 of 02/09/2009
13/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/103
02/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IB/107
02/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/108/G
04/06/2010 Centralised - Variation EMEA/H/C/277/IA/109/G
Updated with Decision(2010)6137 of 01/09/2010
08/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/110
16/06/2010 Corrigendum EMEA/H/C/277/II/97 (2010)4123 corr of 14/06/2010
09/07/2010 Centralised - Variation EMEA/H/C/277/II/106 (2010)4810 of 06/07/2010
13/07/2010 Centralised - Notification EMEA/H/C/277/N/115
Updated with Decision(2011)1157 of 18/02/2011
15/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/113
27/07/2010 Centralised - Variation EMEA/H/C/277/IB/112
Updated with Decision(2011)1157 of 18/02/2011
27/07/2010 Centralised - Variation EMEA/H/C/277/IB/111
Updated with Decision(2011)1157 of 18/02/2011
10/08/2010 Centralised - Variation EMEA/H/C/277/IA/114
Updated with Decision(2011)1157 of 18/02/2011
06/09/2010 Centralised - Renewal EMEA/H/C/277/R/105 (2010)6137 of 01/09/2010
23/09/2010 Centralised - Notification EMEA/H/C/277/N/116
Updated with Decision(2011)1157 of 18/02/2011
15/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/II/117
03/02/2011 Centralised - Notification EMEA/H/C/277/N/118
Updated with Decision(2011)4808 of 29/06/2011
14/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/119
22/02/2011 Centralised - Variation (2011)1157 of 18/02/2011
24/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/277/IA/121
04/07/2011 Centralised - Variation EMEA/H/C/277/II/120, 123 (2011)4808 of 29/06/2011
25/07/2011 Centralised - Variation EMEA/H/C/277/IA/124
Updated with Decision(2011)7788 of 24/10/2011
26/10/2011 Centralised - Variation EMEA/H/C/277/II/125 (2011)7788 of 24/10/2011
01/06/2012 Centralised - Variation EMEA/H/C/277/II/131 (2012)3594 of 25/05/2012
03/09/2012 Centralised - Variation EMEA/H/C/277/IAin/133
Updated with Decision(2012)7736 of 25/10/2012
03/09/2012 Centralised - Variation EMEA/H/C/277/IAin/134/G
Updated with Decision(2012)7736 of 25/10/2012
29/10/2012 Centralised - Variation EMEA/H/C/277/WS/242/G (2012)7736 of 25/10/2012
20/12/2012 Corrigendum (2012)9860 of 18/12/2012
29/08/2013 Centralised - Modification EMEA/H/C/277/PSUV/140 (2013)5620 of 26/08/2013
24/10/2013 Centralised - Variation EMEA/H/C/277/II/142
Updated with Decision(2014)7542 of 10/10/2014
17/01/2014 Centralised - Variation EMEA/H/C/277/IB/146
Updated with Decision(2014)7542 of 10/10/2014
14/10/2014 Centralised - Yearly update (2014)7542 of 10/10/2014