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CHMP beveelt uitbreiding TYSABRI-bijsluiter aan met status van antilichamen voor anti-JC virus als derde factor om risico PML v
WESTON, Mass. & DUBLIN--([ BUSINESS WIRE ])--Biogen Idec (NASDAQ: BIIB) en Elan Corporation, plc (NYSE: ELN) maken vandaag bekend dat het Comit© voor geneesmiddelen voor menselijk gebruik (het CHMP) een positieve mening heeft over het meenemen van een extra risicofactor, namelijk de status van antilichamen voor het anti-JC virus (JCV), in de bijsluiter van TYSABRI (natalizumab) in de Europese Unie (EU). Ook is het CHMP positief over een verlenging van vijf jaar van de goedkeuring voor de marketing van TYSABRI.
Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal welke als enige juridische geldigheid beoogt.