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Progressive Multifokale Leukoenzephalopathie (PML): Seltene Fälle nach Behandlung von MS-Patienten mit Fingolimod (Gilenya)

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11 Juni 2016 – In Abstimmung mit Swissmedic, dem Schweizerischen Heilmittelinstitut, hat Novartis Pharma über das Auftreten in der Vergangenheit  von vereinzelten Fälle von progressiver multifokaler Leukoenzephalopathie (PML) bei Patienten mit schubförmig remittierend verlaufender Multipler Sklerose (MS) nach Behandlung mit Fingolimod (Gilenya) informiert.

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BfArM: Strengere kardiovaskuläre Überwachung zu Beginn der Therapie mit Fingolimod [Gilenya] bei Patienten mit schubförmig-remittierend verlaufender Multipler Sklerose

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27. Januar 2012 – Das BfArM hat heute mitgeteilt, dass ein “Rote Hand Brief” betreffend Fingolimod [Gilenya] mit untenstehendem Wortlaut von der Firma Novartis Pharma versandt wurde.

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Novartis möchte Sie über wichtige zusätzliche Empfehlungen zu mit Fingolimod [Gilenya] informieren. Diese betreffen eine intensivere Überwachung der kardiovaskulären Funktionen innerhalb der ersten 6 Stunden nach Behandlungsbeginn mit Fingolimod [Gilenya],

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