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flatlander_60048

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flatlander_60048

Re: None

Saturday, 01/21/2012 1:11:48 PM

Saturday, January 21, 2012 1:11:48 PM

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Unlike Tsabri, which has a side effect of a rare brain infection, the possible Gilenya cardiac side effects (i.e., bradycardia (a slow heart rate) or atrioventricular block (a problem with the conduction of electricity in the heart)are not as uncommon. Also the NVS instructions for administering the drug are pretty rigorous (see link below). Therefore, the review will need to consider whether all of the requirements were met.

FL

http://www.pharma.us.novartis.com/assets/pdf/REM/Gilenya_HCP_letter.pdf
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