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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.
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...
As with any medicine, the MHRA will keep the safety and effectiveness of concizumab under close review.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia.
Patient reminder cards about the risk of osteonecrosis of the jaw are being introduced; denosumab 120 mg is now contraindicated in patients with unhealed lesions from dental or oral surgery.
Denosumab is associated with a risk of osteonecrosis of the jaw, osteonecrosis of the external auditory canal has also been reported with denosumab.
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.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
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