Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Rivastigmine 1 A Pharma   
Auth. number : EU/1/09/585
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: 1 A Pharma GmbH
Keltenring 1 + 3, D-82041 Oberhaching, 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
16/12/2009 Centralised - Authorisation EMEA/H/C/1181 (2009)10327 of 11/12/2009
31/08/2010 Centralised - Variation EMEA/H/C/1181/IB/1
Updated with Decision(2011)5392 of 20/07/2011
25/07/2011 Centralised - Variation (2011)5392 of 20/07/2011
04/10/2011 Centralised - Variation EMEA/H/C/1181/IA/4/G
Updated with Decision(2012)1188 of 17/02/2012
22/02/2012 Centralised - Variation EMEA/H/C/1181/II/5, 6/G (2012)1188 of 17/02/2012
12/11/2012 Centralised - Variation EMEA/H/C/1181/II/11 (2012)8178 of 08/11/2012
12/04/2013 Centralised - Variation EMEA/H/C/1181/IA/13
Updated with Decision(2014)3095 of 06/05/2014
01/04/2014 Centralised - Notification EMEA/H/C/1181/N/17
Updated with Decision(2014)3095 of 06/05/2014
08/05/2014 Centralised - Yearly update (2014)3095 of 06/05/2014
21/08/2014 Centralised - Renewal EMEA/H/C/1181/R/16 (2014)6029 of 19/08/2014