European Medicines Evaluation Agency Supports Novartis AG' Gilenya With Stronger Warning

Published: Apr 20, 2012

Basel, April 20, 2012 - Novartis announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has confirmed a positive benefit-risk profile of once-daily oral GilenyaR (fingolimod). Novartis and the CHMP have agreed to recommended updates to the product information in the European Union in order to provide further guidance to healthcare providers regarding treatment initiation with Gilenya in MS patients. The changes follow the Article 20 review by the EMA announced in January 2012.

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