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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.
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...
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 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.
Letters were sent to healthcare professionals about Zinbryta▼ (daclizumab beta), Lynparza 50 mg capsules, and radium-223-dichloride (Xofigo▼).
Letters were sent about daclizumab beta (Zinbryta▼), alteplase (Actilyse), Esmya (ulipristal acetate), and Xofigo▼ (radium-223-dichloride). MHRA issued alerts and recalls for batches of Nutriflex Omega Special 2500 ml and Nutriflex Lipid Special 2500 ml.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (7 March 2024) approved the medicine rozanolixizumab (Rystiggo) to treat adults with generalised myasthenia gravis, an autoimmune disease that causes muscle weakness, which can affect multiple muscle groups throughout the...
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Collection of documents relating to COVID-19 treatments.
medac GmbH (t/a medac Pharma LLP) is recalling the product for the batch specified in this notification due to particles detected during long-term stability tests.
Product Recall for Vincenza Jewellery Pave Zircon Initial Cord Bracelet presenting a serious chemical risk.
For the first time, patients with certain types of advanced or recurrent endometrial cancer could access a treatment shown to slow its progression
Current status and future challenges
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
A human medicinal product from India seized at East Midlands Airport.
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