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Novartis AG said it was advising doctors of new recommendations on using Gilenya. They had previously said all patients should be monitored for six hours after their first dose, but are now tightening that to include continuous heart monitoring using electrocardiograms and measuring blood pressure and heart rate every hour. In certain patients, that monitoring should be extended, the drug maker said in a statement.
This new guidance applies only to patients taking their first dose, Novartis said in a statement.
The EU drug regulator hopes to finish its review of the drug by March.
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Online:
European Medicines Agency:
http://europa.eu/agencies/
community_agencies/emea/
Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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