Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Rivastigmine Actavis   
Auth. number : EU/1/11/693
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: Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland
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
21/06/2011 Centralised - Authorisation EMEA/H/C/2036 (2011)4395 of 16/06/2011
01/12/2011 Centralised - Variation EMEA/H/C/2036/IB/1
Updated with Decision(2012)3618 of 25/05/2012
20/04/2012 Centralised - Variation EMEA/H/C/2036/IB/6/G
Updated with Decision(2012)3618 of 25/05/2012
01/06/2012 Centralised - Variation (2012)3618 of 25/05/2012
13/07/2012 Centralised - Variation EMEA/H/C/2036/IB/7
Updated with Decision(2012)7985 of 31/10/2012
06/11/2012 Centralised - Variation (2012)7985 of 31/10/2012
19/04/2013 Centralised - Variation EMEA/H/C/2036/X/5 (2013)2309 of 17/04/2013
27/08/2013 Centralised - Notification EMEA/H/C/2036/N/9
Updated with Decision(2016)1049 of 15/02/2016
15/01/2014 Centralised - Notification EMEA/H/C/2036/N/10
Updated with Decision(2016)1049 of 15/02/2016
12/08/2014 Centralised - Notification EMEA/H/C/2036/N/11
Updated with Decision(2016)1049 of 15/02/2016
03/06/2015 Centralised - Variation EMEA/H/C/2036/IB/13
Updated with Decision(2016)1049 of 15/02/2016
04/09/2015 Centralised - Variation EMEA/H/C/2036/IB/15
Updated with Decision(2016)1049 of 15/02/2016
07/12/2015 Centralised - Variation EMEA/H/C/2036/IB/17
Updated with Decision(2016)1049 of 15/02/2016
17/02/2016 Centralised - Renewal EMEA/H/C/2036/R/16 (2016)1049 of 15/02/2016
17/02/2016 Centralised - Variation EMEA/H/C/2036/IAIN/18/G
25/04/2016 Centralised - Variation EMEA/H/C/2036/IAIN/19