Biogen (BIIB), Elan (ELN) Notes EC Approves Anti-JCV Status in SmPC for TYSABRI
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Biogen Idec (Nasdaq: BIIB) and Elan Corporation, plc (NYSE: ELN) reports the approval by the European Commission (EC) for the inclusion of anti-JC virus (JCV) antibody status as an additional factor to aid in stratifying patients at risk for developing progressive multifocal leukoencephalopathy (PML) in the Summary of Product Characteristics (SmPC) for TYSABRI (natalizumab) in the European Union (EU).
In addition, as part of a standard review process, the EC concluded the quality, safety and efficacy of TYSABRI continue to be adequately demonstrated and renewed the EU five-year Marketing Authorisation.
In addition, as part of a standard review process, the EC concluded the quality, safety and efficacy of TYSABRI continue to be adequately demonstrated and renewed the EU five-year Marketing Authorisation.
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