EMA Communication: The European Medicines Agency has published the first summary for the public of the risk-management plan (RMP) of a newly authorised medicine. This RMP summary, which concerns the medicine Neuraceq, describes what is known and not known about the medicine’s safety and states what measures will be taken to prevent or minimise its risks. The Agency will pilot the publishing of RMP summaries for all newly centrally authorised medicines during 2014 and at a later stage will start producing RMP summaries for previously authorised medicines.
“Neuraceq is used during brain scans in patients with memory problems so that doctors can see whether or not they have significant amounts of β amyloid plaques in the brain. β-amyloid plaques are deposits sometimes present in the brain of people with memory problems caused by dementia (such as Alzheimer’s disease, Lewy-body dementia and Parkinson’s disease dementia) and also in the brain of some elderly people with no symptoms. The type of scan used with Neuraceq is called positron-emission tomography (PET).”
The press release is available by clicking here.