CHMP recommends approval of generic memantine product (Memantine ratiopharm)

Source: European Medicines Agency Area: News The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the granting of a marketing authorisation for Memantine ratiopharm for the treatment of patients with moderate to severe Alzheimer's disease.   Memantine ratiopharm is a generic of Ebixa® (authorised in the EU in May 2002), and has been shown to be bioequivalent to this reference product   Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) after the marketing authorisation has been granted by the European Commission.   [Editor's note: The UK SPC for Ebixa® is not due to expire until April 2014.]
Source: NeLM - Mental Health - Category: Psychiatry Source Type: news