ARTICLE
13 November 2015

EMA Issues Recommendations To Minimize Risk Of Rare Brain Infection PML With Tecfidera

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Jones Day
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Jones Day is a global law firm with more than 2,500 lawyers across five continents. The Firm is distinguished by a singular tradition of client service; the mutual commitment to, and the seamless collaboration of, a true partnership; formidable legal talent across multiple disciplines and jurisdictions; and shared professional values that focus on client needs.
On October 23, 2015, the CHMP gave new advice for doctors and patients in order to minimize the risk of progressive multifocal leukoencephalopathy in patients treated with the multiple sclerosis medicine Tecfidera.
European Union Food, Drugs, Healthcare, Life Sciences
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On October 23, 2015, the CHMP gave new advice for doctors and patients in order to minimize the risk of progressive multifocal leukoencephalopathy ("PML") in patients treated with the multiple sclerosis medicine Tecfidera ("dimethyl fumarate"). PML is a rare brain infection caused by the John Cunningham virus. EMA has recommended that a complete blood count should be performed before starting treatment with Tecfidera and every three months during treatment. Additionally, a baseline MRI should be available as a reference (usually within three months).

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ARTICLE
13 November 2015

EMA Issues Recommendations To Minimize Risk Of Rare Brain Infection PML With Tecfidera

European Union Food, Drugs, Healthcare, Life Sciences
Contributor
Jones Day is a global law firm with more than 2,500 lawyers across five continents. The Firm is distinguished by a singular tradition of client service; the mutual commitment to, and the seamless collaboration of, a true partnership; formidable legal talent across multiple disciplines and jurisdictions; and shared professional values that focus on client needs.
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