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Elan propose updated item labeling for TYSABRI to FDA and EMA Biogen Idec and Elan Company.

Food and Medication Administration and a sort II Variation to the European Medications Agency to demand review and authorization to update the particular TYSABRI Prescribing Info and Summary of Item Characteristics. The firms are proposing updated item labeling to add anti-JC Virus antibody position as you potential factor to greatly help stratify the chance of progressive multifocal leukoencephalopathy , a uncommon but serious brain disease, in the TYSABRI-treated inhabitants. These filings are section of the companies’ ongoing dedication to actively recognize and address potential risk elements for PML in TYSABRI-treated patients.. Biogen Idec, Elan propose updated item labeling for TYSABRI to FDA and EMA Biogen Idec and Elan Company, plc announced that the firms have got submitted a supplemental Biologics Permit Software to the U.S.