CHMP recommends approval of generic memantine products

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 the following memantine products for the treatment of patients with moderate to severe Alzheimer's disease:   . Memantine LEK (Pharmathen S.A) . Memantine Mylan (Generics (UK) Ltd) . Nemdatine (Actavis Group PTC)   These products are all generics of Ebixa®, which has been authorised in the EU since May 2002. Studies have demonstrated the satisfactory quality of these products and their bioequivalence with the reference product.   Detailed recommendations for the use of these products will be described in the Summary of Product Characteristics, which will be available after the marketing authorisations have 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