Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Prometax   
Auth. number : EU/1/98/092
Active substance : 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
Frimley Business Park, Camberley GU16 7SR, 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
09/12/1998 Centralised - Authorisation EMEA/H/C/255 (1998)3979 of 04/12/1998
19/03/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/I/2
19/03/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/I/6
19/03/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/I/5
19/03/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/I/1
19/03/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/I/4
12/07/1999 Centralised - Variation EMEA/H/C/255/I/7 (1999)1905 of 02/07/1999
13/04/2000 Centralised - Variation EMEA/H/C/255/II/8 (2000)966 of 12/04/2000
15/05/2000 Centralised - Authorisation EMEA/H/C/255/X/9 (2000)1198 of 11/05/2000
19/12/2000 Centralised - Variation EMEA/H/C/255/I/11 (2000)3513 of 18/12/2000
19/12/2000 Centralised - Variation EMEA/H/C/255/I/10 (2000)3509 of 18/12/2000
13/03/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/I/13
13/03/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/I/14
22/03/2001 Centralised - Variation EMEA/H/C/255/II/12 (2001)618 of 20/03/2001
14/08/2001 Centralised - Variation EMEA/H/C/255/II/15 (2001)2113 of 13/08/2001
15/11/2001 Centralised - Variation EMEA/H/C/255/I/16 (2001)3519 of 09/11/2001
03/12/2001 Centralised - Notification EMEA/H/C/255/N/17 (2001)3892 of 30/11/2001
07/03/2002 Centralised - Variation EMEA/H/C/225/I/18, 19 (2002)974 of 05/03/2002
21/10/2002 Centralised - Variation EMEA/H/C/255/II/20 (2002)4061 of 17/10/2002
23/12/2002 Centralised - Variation EMEA/H/C/255/II/21 (2002)5436 of 18/12/2002
13/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/I/22
30/06/2003 Centralised - Renewal EMEA/H/C/255/R/23 (2003)2126 of 26/06/2003
24/09/2003 Centralised - Notification EMEA/H/C/255/N/24 (2003)3417 of 22/09/2003
19/12/2003 Centralised - Variation EMEA/H/C/255/IA/27
Updated with Decision(2004)775 of 04/03/2004
04/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/IA/29
08/03/2004 Centralised - Variation EMEA/H/C/255/II/28 (2004)778 of 04/03/2004
08/03/2004 Centralised - Variation EMEA/H/C/255/II/25 (2004)775 of 04/03/2004
02/08/2004 Centralised - Notification EMEA/H/C/255/N/31
Updated with Decision(2006)728 of 02/03/2006
03/02/2005 Centralised - Notification EMEA/H/C/255/N/32
Updated with Decision(2006)728 of 02/03/2006
07/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/IA/34
07/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/IA/35
06/03/2006 Centralised - Variation EMEA/H/C/255/II/33 (2006)728 of 02/03/2006
15/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/IA/36
19/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/IB/41
02/08/2006 Centralised - Notification EMEA/H/C/255/N/38
Updated with Decision(2006)5178 of 24/10/2006
19/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/IB/40
26/10/2006 Centralised - Variation EMEA/H/C/255/II/37 (2006)5178 of 24/10/2006
28/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/II/42, 43
09/03/2007 Centralised - Notification EMEA/H/C/255/N/44
Updated with Decision(2007)4487 of 25/09/2007
27/09/2007 Centralised - Variation EMEA/H/C/255/X/39 (2007)4487 of 25/09/2007
04/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/IA/46
23/05/2008 Centralised - Renewal EMEA/H/C/255/R/45 (2008)2186 of 21/05/2008
04/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/IA/50
19/06/2008 Corrigendum EMEA/H/C/255/R/45 (2008)2186 of 21/05/2008
26/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/IB/55
09/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/IB/53
09/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/IB/52
09/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/IB/54
12/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/IA/56
18/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/IA/57
28/01/2009 Centralised - Variation EMEA/H/C/255/II/51 (2009)556 of 26/01/2009
24/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/IB/60
24/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/IB/61
25/03/2010 Centralised - Variation EMEA/H/C/255/II/59 (2010)2030 of 23/03/2010
04/05/2010 Centralised - Variation EMEA/H/C/255/II/58 (2010)2941 of 29/04/2010
28/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/WS/31
25/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/IG/25/G
20/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/255/WS/IB/32
20/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/225/WS/36/G
13/01/2011 Centralised - Variation EMEA/H/C/255/IG/32/G
Updated with Decision(2011)1779 of 14/03/2011
16/03/2011 Centralised - Variation (2011)1779 of 14/03/2011
25/05/2011 Centralised - Variation EMEA/H/C/255/WS/119, 121/G (2011)3727 of 23/05/2011
19/07/2011 Centralised - Variation EMEA/H/C/225/IG/75/G
Updated with Decision(2011)9286 of 07/12/2011
12/12/2011 Centralised - Variation EMEA/H/C/255/WS/178 (2011)9286 of 07/12/2011
17/04/2012 Centralised - Variation EMEA/H/C/225/WS/132 (2012)2540 of 13/04/2012
17/01/2013 Centralised - Variation EMEA/H/C/255/X/78/G (2013)215 of 14/01/2013
26/07/2013 Centralised - Notification EMEA/H/C/255/N/28
Updated with Decision(2014)8412 of 07/11/2014
05/09/2013 Centralised - Notification EMEA/H/C/255/N/90
Updated with Decision(2014)8412 of 07/11/2014
16/10/2013 Centralised - Variation EMEA/H/C/255/IAin/91
Updated with Decision(2014)8412 of 07/11/2014
11/11/2014 Centralised - Yearly update (2014)8412 of 07/11/2014
18/12/2014 Centralised - Variation EMEA/H/C/255/WS/624
Updated with Decision(2015)8270 of 19/11/2015
18/12/2014 Centralised - Variation EMEA/H/C/255/WS/625
Updated with Decision(2015)8270 of 19/11/2015
22/01/2015 Centralised - Variation EMEA/H/C/255/WS/622
Updated with Decision(2015)8270 of 19/11/2015
22/01/2015 Centralised - Variation EMEA/H/C/255/WS/623
Updated with Decision(2015)8270 of 19/11/2015
26/03/2015 Centralised - Variation EMEA/H/C/255/WS/621
Updated with Decision(2015)8270 of 19/11/2015
08/05/2015 Centralised - Variation EMEA/H/C/255/IA/564
Updated with Decision(2015)8270 of 19/11/2015
28/07/2015 Centralised - Notification EMEA/H/C/255/N/109
Updated with Decision(2015)8270 of 19/11/2015
24/09/2015 Centralised - Variation EMEA/H/C/255/II/WS/743
Updated with Decision(2015)8270 of 19/11/2015
23/11/2015 PSUSA - Modification EMEA/H/C/255/PSUSA/2654/201501 (2015)8270 of 19/11/2015
19/01/2016 Corrigendum
This corrigendum concerns the French Annexes to the Decision and only corrects the procedure PSUSA 2654-201501; the errors in the French Annexes however were introduced with variation EMEA/H/C/255/WS/119, 121/G (Commission Decision (2011)3727 of 23/5/2011).
(2015)8270 of 19/11/2015