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Dear Doctor Letter (Rote-Hand-Brief) on Fumaderm® initial / Fumaderm® (fumaric acid ester): Measures to reduce the risk of progressive multifocal leukoencephalopathy (PML)

2015.11.24

Active substance: fumaric acid ester

After a hearing under the graduated plan procedure ("Stufenplanverfahren"), stage II and conclusion of the variation worksharing procedure, the company Biogen Idec GmbH is circulating information on measures to reduce the risk of progressive multifocal leukoencephalopathy (PML).

Download DHPC/Information letter , Download_VeroeffentlichtAm_EN PDF, 713KB, File is accessible