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Non-arteritic anterior ischemic optic neuropathy (NAION), a condition that can cause sudden deterioration in vision, usually in one eye at a time, has been very rarely reported in association with semaglutide in the treatment of type 2 diabetes, weight management...
Serious and life-threatening hypercalcaemia has been reported with denosumab 60mg (Prolia) in children and adolescents in clinical trials for osteogenesis imperfecta and during off-label use. Denosumab 60mg (Prolia) is authorised for use in adults with osteoporosis and other bone loss...
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
Evaluate a patient’s individual factors for benefits and risks before initiating treatment with denosumab 60mg, particularly in those with previous vertebral fracture. Patients should not stop denosumab without specialist review.
Rare cases of atypical femoral fracture with long-term use.
Minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia.
As with any medicine, the MHRA will keep the safety and effectiveness of Nirogacestat hydrobromide under close review.
Fatal cases of severe symptomatic hypocalcaemia, and risk of hypocalcaemia at any time during treatment.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
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