Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Exelon   
Auth. number : EU/1/98/066
INN : Rivastigmine
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N06 - Psychoanaleptics
Pharmacological subgroup: N06D - Anti-dementia drugs
Chemical subgroup: N06DA - Anticholinesterases
Chemical substance: N06DA03 - Rivastigmine
(See WHO ATC Index)
Indication: Symptomatic treatment of mild to moderately severe Alzheimer´s dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson´s disease.
Marketing Authorisation Holder: Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

  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
12/05/1998 Centralised - Authorisation EMEA/H/C/169 (1998)1306 of 12/05/1998
11/06/1999 Centralised - Authorisation EMEA/H/C/169/X/1 (1999)1443 of 02/06/1999
16/07/1999 Centralised - Variation EMEA/H/C/169/I/8 (1999)1910 of 08/07/1999
16/07/1999 Centralised - Variation EMEA/H/C/169/I/3 (1999)1911 of 08/07/1999
13/04/2000 Centralised - Variation EMEA/H/C/169/II/9 (2000)965 of 12/04/2000
04/12/2000 Centralised - Variation EMEA/H/C/169/I/12 (2000)3234 of 01/12/2000
04/12/2000 Centralised - Variation EMEA/H/C/169/I/11 (2000)3425 of 01/12/2000
13/03/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/I/15
13/03/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/I/14
22/03/2001 Centralised - Variation EMEA/H/C/169/II/13 (2001)576 of 20/03/2001
03/08/2001 Centralised - Variation EMEA/H/C/169/II/16 (2001)2072 of 01/08/2001
16/11/2001 Centralised - Variation EMEA/H/C/169/I/17 (2001)3541 of 15/11/2001
20/12/2001 Centralised - Notification EMEA/H/C/169/N/18 (2001)4323 of 17/12/2001
15/03/2002 Centralised - Variation EMEA/H/C/169/I/19, 20 (2002)1129 of 13/03/2002
12/09/2002 Centralised - Variation EMEA/H/C/169/II/21 (2002)3385 of 10/09/2002
09/01/2003 Centralised - Variation EMEA/H/C/169/II/22 (2003)11 of 07/01/2003
13/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/I/23
03/07/2003 Centralised - Renewal EMEA/H/C/169/R/24 (2003)2229 of 30/06/2003
22/10/2003 Centralised - Variation EMEA/H/C/169/I/27
Updated with Decision(2004)776 of 04/03/2004
04/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IA/29
08/03/2004 Centralised - Variation EMEA/H/C/169/II/25 (2004)776 of 04/03/2004
08/03/2004 Centralised - Variation EMEA/H/C/169/II/28 (2004)777 of 04/03/2004
26/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IA/30
30/09/2004 Centralised - Notification EMEA/H/C/169/N/32
Updated with Decision(2006)697 of 28/02/2006
30/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IA/34
07/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IA/35
31/01/2006 Centralised - Notification EMEA/H/C/169/N/31
Updated with Decision(2006)697 of 28/02/2006
02/03/2006 Centralised - Variation EMEA/H/C/169/II/33 (2006)697 of 28/02/2006
15/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IA/36
19/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IB/40
19/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IB/39
30/10/2006 Centralised - Variation EMEA/H/C/169/II/37 (2006)5210 of 26/10/2006
07/03/2007 Centralised - Notification EMEA/H/C/169/N/43
Updated with Decision(2007)4376 of 17/09/2007
20/09/2007 Centralised - Variation EMEA/H/C/169/X/38 (2007)4376 of 17/09/2007
04/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IA/45
11/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IB/48
11/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IB/47
22/05/2008 Centralised - Renewal EMEA/H/C/169/R/44 (2008)2023 of 20/05/2008
04/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IA/49
26/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IB/52
09/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IB/51
12/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IA/53
18/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IA/54
04/02/2009 Centralised - Variation EMEA/H/C/169/II/50 (2009)701 of 30/01/2009
02/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IB/58
02/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IB/57
25/03/2010 Centralised - Variation EMEA/H/C/169/II/56 (2010)2033 of 23/03/2010
29/04/2010 Centralised - Variation EMEA/H/C/169/II/55 (2010)2842 of 27/04/2010
28/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/WS/31
25/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/IG/25/G
21/12/2010 Centralised - Variation EMEA/H/C/169/IG/32/G
Updated with Decision(2011)1896 of 17/03/2011
22/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/WS/32
04/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/169/WS/36/G
22/03/2011 Centralised - Variation (2011)1896 of 17/03/2011
26/05/2011 Centralised - Variation EMEA/H/C/169/WS/119, EMEA/H/C/169/WS/121/G (2011)3713 of 23/05/2011
19/07/2011 Centralised - Variation EMEA/H/C/169/IG/75/G
Updated with Decision(2011)8515 of 16/11/2011
18/11/2011 Centralised - Variation EMEA/H/C/169/WS/178 (2011)8515 of 16/11/2011
26/03/2012 Centralised - Variation EMEA/H/C/169/WS/132 (2012)2867 of 20/04/2012
16/01/2013 Centralised - Variation EMEA/H/C/169/X/75/G (2013)132 of 14/01/2013
08/04/2013 Centralised - Variation EMEA/H/C/169/IA/84
Updated with Decision(2014)2447 of 07/04/2014
16/05/2013 Centralised - Variation EMEA/H/C/169/IA/87/G
Updated with Decision(2014)2447 of 07/04/2014
16/05/2013 Centralised - Variation EMEA/H/C/169/IA/88/G
Updated with Decision(2014)2447 of 07/04/2014
23/01/2014 Centralised - Notification EMEA/H/C/169/N/97
Updated with Decision(2014)2447 of 07/04/2014
09/04/2014 Centralised - Yearly update (2014)2447 of 07/04/2014