Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Axura   
Auth. number : EU/1/02/218
Active substance : 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: Merz Pharmaceuticals GmbH
Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland
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
22/05/2002 Centralised - Authorisation EMEA/H/C/378 (2002)1953 of 17/05/2002
23/07/2002 Centralised - Variation EMEA/H/C/378/I/1 (2002)2860 of 19/07/2002
04/10/2002 Centralised - Variation EMEA/H/C/378/I/2, 6 (2002)3707 of 02/10/2002
30/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/378/I/7
03/09/2003 Corrigendum EMEA/H/C/378 (2003)3201 of 01/09/2003
18/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/378/I/9
15/07/2004 Centralised - Variation EMEA/H/C/378/II/10 (2004)2802 of 13/07/2004
29/04/2005 Centralised - Notification EMEA/H/C/378/N/12
Updated with Decision(2005)4511 of 15/11/2005
18/11/2005 Centralised - Variation EMEA/H/C/378/II/11 (2005)4511 of 15/11/2005
02/05/2006 Centralised - Variation EMEA/H/C/378/II/13 (2006)1814 of 27/04/2006
01/12/2006 Centralised - Variation EMEA/H/C/378/II/14 (2006)5919 of 28/11/2006
14/12/2006 Centralised - Variation EMEA/H/C/378/IB/18
26/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/378/IB/20
29/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/378/II/16
29/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/378/II/17
21/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/378/IB/19
25/06/2007 Centralised - Renewal EMEA/H/C/378/R/15 (2007)3105 of 20/06/2007
30/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/378/IA/32
02/08/2007 Centralised - Variation EMEA/H/C/378/II/21, 23 (2007)3761 of 30/07/2007
20/09/2007 Centralised - Variation EMEA/H/C/378/IB/33
Updated with Decision(2008)1894 of 08/05/2008
20/09/2007 Centralised - Variation EMEA/H/C/378/IA/34
Updated with Decision(2008)1894 of 08/05/2008
20/09/2007 Centralised - Variation EMEA/H/C/378/IA/35
Updated with Decision(2008)1894 of 08/05/2008
20/09/2007 Centralised - Variation EMEA/H/C/378/IA/36
Updated with Decision(2008)1894 of 08/05/2008
08/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/378/IB/37
14/05/2008 Centralised - Variation EMEA/H/C/378/X/30 (2008)1895 of 08/05/2008
14/05/2008 Centralised - Variation EMEA/H/C/378/II/24 (2008)1894 of 08/05/2008
22/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/378/IA/39
24/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/378/IB/38
12/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/378/IB/42
01/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/378/IA/43
04/12/2008 Centralised - Variation EMEA/H/C/378/II/41 (2008)8010 of 02/12/2008
21/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/378/IA/4
03/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/378/IB/45
26/06/2009 Centralised - Variation EMEA/H/C/378/II/47 (2009)5208 of 24/06/2009
04/08/2009 Centralised - Variation EMEA/H/C/378/II/48 (2009)6239 of 31/07/2009
20/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/378/II/49
25/03/2010 Centralised - Variation EMEA/H/C/378/II/50 (2010)2025 of 23/03/2010
04/06/2010 Centralised - Variation EMEA/H/C/378/IB/51
Updated with Decision(2010)7526 of 25/10/2010
26/07/2010 Centralised - Notification EMEA/H/C/378/N/52
Updated with Decision(2010)7526 of 25/10/2010
14/09/2010 Centralised - Variation EMEA/H/C/378/IA/53
Updated with Decision(2010)7526 of 25/10/2010
27/10/2010 Centralised - Variation EMEA/H/C/378/II/54 (2010)7526 of 25/10/2010
14/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/378/IB/55
04/11/2011 Centralised - Variation EMEA/H/C/378/II/56 (2011)7938 of 27/10/2011
16/05/2012 Centralised - Variation EMEA/H/C/378/IB/60/G
Updated with Decision(2012)8009 of 31/10/2012
12/11/2012 Centralised - Variation (2012)8009 of 31/10/2012
28/04/2014 Centralised - Variation EMEA/H/C/378/WS/562
Updated with Decision(2015)2536 of 13/04/2015
04/09/2014 Centralised - Notification EMEA/H/C/378/N/66
Updated with Decision(2015)2536 of 13/04/2015
15/04/2015 Centralised - Yearly update (2015)2536 of 13/04/2015
31/07/2015 Centralised - Notification EMEA/H/C/378/N/70
02/12/2015 Centralised - Notification EMEA/H/C/378/N/72