Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Nimvastid   
Auth. number : EU/1/09/525
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: Krka, d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija

  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
13/05/2009 Centralised - Authorisation EMEA/H/C/1029 (2009)3906 of 11/05/2009
17/06/2009 Centralised - Variation EMEA/H/C/1029/IA/1
21/07/2009 Centralised - Variation EMEA/H/C/1029/IA/2
Updated with Decision(2010)1803 of 15/03/2010
21/07/2009 Centralised - Variation EMEA/H/C/1029/IA/3
Updated with Decision(2010)1803 of 15/03/2010
21/07/2009 Centralised - Variation EMEA/H/C/1029/IA/4
Updated with Decision(2010)1803 of 15/03/2010
21/07/2009 Centralised - Variation EMEA/H/C/1029/IA/5
Updated with Decision(2010)1803 of 15/03/2010
17/03/2010 Centralised - Variation (2010)1803 of 15/03/2010
23/06/2010 Centralised - Variation EMEA/H/C/1029/IB/6
Updated with Decision(2011)190 of 13/01/2011
17/01/2011 Centralised - Variation (2011)190 of 13/01/2011
01/09/2011 Centralised - Variation EMEA/H/C/1029/IB/7/G
Updated with Decision(2012)2180 of 26/03/2012
15/11/2011 Centralised - Variation EMEA/H/C/1029/N/8
Updated with Decision(2012)2180 of 26/03/2012
28/03/2012 Centralised - Variation (2012)2180 of 26/03/2012
05/06/2012 Centralised - Variation EMEA/H/C/1029/IB/9
Updated with Decision(2012)7918 of 29/10/2012
02/07/2012 Centralised - Variation EMEA/H/C/1029/IB/10
Updated with Decision(2012)7918 of 29/10/2012
05/11/2012 Centralised - Variation (2012)7918 of 29/10/2012
21/01/2014 Centralised - Renewal EMEA/H/C/1029/R/12 (2014)314 of 16/01/2014