Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Rivastigmine Sandoz   
Auth. number : EU/1/09/599
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: Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich
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
15/12/2009 Centralised - Authorisation EMEA/H/C/1183 (2009)10328 of 11/12/2009
31/08/2010 Centralised - Variation EMEA/H/C/1183/IB/1
Updated with Decision(2011)5384 of 20/07/2011
25/07/2011 Centralised - Variation (2011)5384 of 20/07/2011
04/10/2011 Centralised - Variation EMEA/H/C/1183/IA/4/G
Updated with Decision(2012)1182 of 17/02/2012
21/02/2012 Centralised - Variation EMEA/H/C/1183/II/5, 6/G (2012)1182 of 17/02/2012
06/11/2012 Centralised - Variation EMEA/H/C/1183/II/11 (2012)8007 of 31/10/2012
12/04/2013 Centralised - Variation EMEA/H/C/1183/IAin/13
Updated with Decision(2014)2914 of 28/04/2014
26/03/2014 Centralised - Notification EMEA/H/C/1183/N/17
Updated with Decision(2014)2914 of 28/04/2014
30/04/2014 Centralised - Yearly update (2014)2914 of 28/04/2014
15/07/2014 Centralised - Renewal EMEA/H/C/1183/R/16 (2014)5048 of 11/07/2014
10/04/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1183/T/19 (2015)2434 of 08/04/2015
02/12/2015 PSUSA - Modification EMEA/H/C/1183/PSUSA/2654/201501 (2015)8593 of 27/11/2015
16/08/2016 Centralised - Variation EMEA/H/C/1183/IB/23/G
Updated with Decision(2017)5167 of 17/07/2017
19/07/2017 Centralised - Yearly update (2017)5167 of 17/07/2017