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The European Medicines Agency (EMA) has recommended the immediate suspension of the marketing authorisation and recall of daclizumab (Zinbryta) in the EU following reports of serious inflammatory brain disorders, including encephalitis and meningoencephalitis, in patients with multiple sclerosis.
While an urgent EU-wide review of new information on liver safety is under way, promptly review patients on treatment. Only initiate daclizumab in restricted groups of patients with limited treatment options and keep all patients under close liver function monitoring.
Monitoring for encephalitis should continue for 12 months following discontinuation of daclizumab. Inform all patients who have discontinued daclizumab and their caregivers of the common symptoms of encephalitis and the need to contact their doctor immediately if they occur.
The use of daclizumab (daclizumab beta) is now restricted to adults with relapsing multiple sclerosis who have had an inadequate response to at least 2 other disease-modifying therapies (DMTs) and for whom other DMTs are contraindicated or unsuitable. Do not...
As with all products, we will keep its safety under close review
As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used
As with any medicine, the MHRA will keep the safety and effectiveness of concizumab under close review.
As with all products, the MHRA will keep its safety under close review.
There is a risk of patient harm arising through medication error during a transition period where the original and new formulation of Rybelsus ® tablets, which have different stated mg doses but are bioequivalent, will both be available on the...
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