Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ebixa   
Auth. number : EU/1/02/219
INN : Memantine
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N06 - Psychoanaleptics
Pharmacological subgroup: N06D - Anti-dementia drugs
Chemical subgroup: N06DX - Other anti-dementia drugs
Chemical substance: N06DX01 - Memantine
(See WHO ATC Index)
Indication: Treatment of patients with moderate to severe Alzheimer´s disease
Marketing Authorisation Holder: H. Lundbeck A/S
Ottiliavej 9, DK-2500 Valby, Danmark

  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
17/05/2002 Centralised - Authorisation EMEA/H/C/463 (2002)1939 of 15/05/2002
01/10/2002 Centralised - Variation EMEA/H/C/463/I/1, 3 (2002)3638 of 27/09/2002
21/11/2002 Centralised - Variation EMEA/H/C/463/II/5 (2002)4576 of 20/11/2002
06/08/2003 Centralised - Variation EMEA/H/C/463/I/7
06/08/2003 Centralised - Variation EMEA/H/C/463/I/6
01/09/2003 Centralised - Variation EMEA/H/C/463/I/8/11 (2003)3172 of 28/08/2003
03/09/2003 Other procedure EMEA/H/C/463 (2003)3195 of 01/09/2003
18/09/2003 Centralised - Variation EMEA/H/C/463/I/13
15/07/2004 Centralised - Variation EMEA/H/C/463/II/14 (2004)2811 of 13/07/2004
26/04/2005 Centralised - Variation EMEA/H/C/463/N/16
Updated with Decision(2005)4487 of 15/11/2005
18/11/2005 Centralised - Variation EMEA/H/C/463/II/15 (2005)4487 of 15/11/2005
01/05/2006 Centralised - Variation EMEA/H/C/463/II/17 (2006)1793 of 27/04/2006
18/09/2006 Centralised - Variation EMEA/H/C/463/IA/23
Updated with Decision(2006)5918 of 28/11/2006
19/09/2006 Centralised - Variation EMEA/H/C/463/IA/21
Updated with Decision(2006)5918 of 28/11/2006
20/09/2006 Centralised - Variation EMEA/H/C/463/IA/20
Updated with Decision(2006)5918 of 28/11/2006
20/09/2006 Centralised - Variation EMEA/H/C/463/IA/22
Updated with Decision(2006)5918 of 28/11/2006
01/12/2006 Centralised - Variation EMEA/H/C/463/II/24 (2006)5918 of 28/11/2006
14/12/2006 Centralised - Variation EMEA/H/C/463/IB/26
13/04/2007 Centralised - Variation EMEA/H/C/463/IB/30
22/05/2007 Centralised - Variation EMEA/H/C/463/IB/29
15/06/2007 Centralised - Renewal EMEA/H/C/463/R/27 (2007)2601 of 13/06/2007
27/07/2007 Centralised - Variation EMEA/H/C/463/IA/44
16/08/2007 Centralised - Variation EMEA/H/C/463/IA/50
Updated with Decision(2008)1608 of 17/04/2008
16/08/2007 Centralised - Variation EMEA/H/C/463/IA/49
Updated with Decision(2008)1608 of 17/04/2008
16/08/2007 Centralised - Variation EMEA/H/C/463/IA/48
Updated with Decision(2008)1608 of 17/04/2008
16/08/2007 Centralised - Variation EMEA/H/C/463/IA/47
Updated with Decision(2008)1608 of 17/04/2008
16/08/2007 Centralised - Variation EMEA/H/C/463/IA/45
Updated with Decision(2008)1608 of 17/04/2008
16/08/2007 Centralised - Variation EMEA/H/C/463/IA/46
Updated with Decision(2008)1608 of 17/04/2008
29/08/2007 Centralised - Variation EMEA/H/C/463/II/31, 33 (2007)4079 of 27/08/2007
21/04/2008 Centralised - Variation (2008)1608 of 17/04/2008
14/05/2008 Centralised - Variation EMEA/H/C/463/X/42 (2008)1893 of 08/05/2008
14/05/2008 Centralised - Variation EMEA/H/C/463/II/41 (2008)1896 of 08/05/2008
15/05/2008 Centralised - Variation EMEA/H/C/463/IB/51
11/06/2008 Centralised - Variation EMEA/H/C/463/IA/53
07/07/2008 Centralised - Variation EMEA/H/C/463/IB/52
12/11/2008 Centralised - Variation EMEA/H/C/463/IB/56
04/12/2008 Centralised - Variation EMEA/H/C/463/II/55 (2008)8009 of 02/12/2008
12/01/2009 Centralised - Variation EMEA/H/C/463/II/63
09/02/2009 Centralised - Variation EMEA/H/C/463/IA/58
09/02/2009 Centralised - Variation EMEA/H/C/463/IA/57
03/06/2009 Centralised - Variation EMEA/H/C/463/II/54 (2009)4381 of 29/05/2009
25/06/2009 Centralised - Variation EMEA/H/C/463/II/59 (2009)5146 of 23/06/2009
30/07/2009 Centralised - Variation EMEA/H/C/463/IA/61
Updated with Decision(2009)9331 of 20/11/2009
31/07/2009 Centralised - Variation EMEA/H/C/463/II/60 (2009)6186 of 29/07/2009
24/11/2009 Centralised - Variation EMEA/H/C/463/II/62 (2009)9331 of 20/11/2009
23/12/2009 Centralised - Variation EMEA/H/C/463/IA/65
30/03/2010 Centralised - Variation EMEA/H/C/463/II/64 (2010)2188 of 26/03/2010
04/06/2010 Centralised - Variation EMEA/H/C/463/IB/66
Updated with Decision(2010)7531 of 25/10/2010
27/10/2010 Centralised - Variation EMEA/H/C/463/II/67 (2010)7531 of 25/10/2010
20/12/2010 Centralised - Variation EMEA/H/C/463/IB/68
23/03/2011 Centralised - Variation EMEA/H/C/463/IA/69
26/10/2011 Centralised - Variation EMEA/H/C/463/II/70 (2011)7804 of 24/10/2011
16/05/2012 Centralised - Variation EMEA/H/C/463/IB/74/G
Updated with Decision(2012)8010 of 31/10/2012
12/11/2012 Centralised - Variation (2012)8010 of 31/10/2012
08/07/2013 Centralised - Variation EMEA/H/C/463/N/78