Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Rivastigmine HEXAL   
Auth. number : EU/1/09/589
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: Hexal AG
Industriestrasse 25, D-83607 Holzkirchen, 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
15/12/2009 Centralised - Authorisation EMEA/H/C/1182 (2009)10329 of 11/12/2009
31/08/2010 Centralised - Variation EMEA/H/C/1182/IB/1
Updated with Decision(2011)1794 of 14/03/2011
21/03/2011 Centralised - Variation (2011)1794 of 14/03/2011
04/10/2011 Centralised - Variation EMEA/H/C/1182/IA/4/G
Updated with Decision(2012)897 of 09/02/2012
13/02/2012 Centralised - Variation EMEA/H/C/1182/II/5, 6/G (2012)897 of 09/02/2012
03/12/2012 Centralised - Variation EMEA/H/C/1182/II/11 (2012)8706 of 22/11/2012
12/04/2013 Centralised - Variation EMEA/H/C/1182/IAin/13
Updated with Decision(2014)2803 of 23/04/2014
25/03/2014 Centralised - Variation EMEA/H/C/1182/N/17
Updated with Decision(2014)2803 of 23/04/2014
25/04/2014 Centralised - Variation (2014)2803 of 23/04/2014
15/07/2014 Centralised - Renewal (2014)5054 of 11/07/2014