Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Rivastigmine Teva
Auth. number : EU/1/09/513
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: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland

  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
21/04/2009 Centralised - Authorisation EMEA/H/C/1044 (2009)3064 of 17/04/2009
23/06/2009 Centralised - Variation EMEA/H/C/1044/IA/1
Updated with Decision(2010)599 of 27/01/2010
12/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1044/IA/3
12/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1044/IA/2
12/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1044/IA/4
19/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1044/IA/5
29/01/2010 Centralised - Variation (2010)599 of 27/01/2010
04/06/2011 Centralised - Variation EMEA/H/C/1044/IB/6
Updated with Decision(2011)5688 of 01/08/2011
03/08/2011 Centralised - Variation (2011)5688 of 01/08/2011
16/08/2011 Centralised - Variation EMEA/H/C/1044/IA/7/G
Updated with Decision(2012)1557 of 06/03/2012
01/09/2011 Centralised - Variation EMEA/H/C/1044/IB/8/G
Updated with Decision(2012)1557 of 06/03/2012
08/03/2012 Centralised - Variation (2012)1557 of 06/03/2012
12/09/2012 Centralised - Withdrawal (2012)6390 of 10/09/2012