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La Comisin Europea aprueba la inclusin del estatus de anticuerpo anti- JCV como factor de riesgo PML en la etiqueta de TYSABRI
WESTON, Massachussets & DUBLIN--([ BUSINESS WIRE ])--[ Biogen Idec ] (NASDAQ: BIIB) y [ Elan Corporation ], plc (NYSE: ELN) han comunicado que la Comisin Europea ha aprobado la inclusin del estatus de anticuerpo anti.-JCV como factor adicional para estratificar los pacientes con riesgo de desarrollar PML (eucoencefalopata multifocal progresiva) en el resumen de las caractersticas de producto (SmPC) de [ TYSABRI ]® (natalizumab) en la UE. Adems, como parte del proceso de revisin estndar, la Comisin Europea ha determinado que la calidad, seguridad y eficacia de TYSABRI continan siendo adecuadamente demostradas y ha renovado la autorizacin de marketing para cinco aos en la Unin Europea.
El comunicado en el idioma original, es la versin oficial y autorizada del mismo. La traduccin es solamente un medio de ayuda ydeber sercomparada con el texto en idioma original, que es la nica versin del texto que tendr validez legal.