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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/13/820|
|ATC:||Anatomical main group: N - Nervous system|
Therapeutic subgroup: N06 - Psychoanaleptics
Pharmacological subgroup: N06D - Anti-dementia drugs
Chemical subgroup: N06DX - Other anti-dementia drugs
Chemical substance: N06DX01 - Memantine
(See WHO ATC Index)
|Indication:||Treatment of patients with moderate to severe Alzheimer’s disease.|
|Marketing Authorisation Holder:||Consilient Health Ltd.
Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|06/05/2013||Centralised - Authorisation||EMEA/H/C/2658||(2013)2638 of 29/04/2013|
|08/08/2013||Centralised - Transfer Marketing Authorisation Holder||EMEA/H/C/2658/T/2||(2013)5288 of 05/08/2013|
|09/08/2013||Centralised - Variation||EMEA/H/C/2658/IAin/3|