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Flamingo Pharma UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Guidance on using non-investigational medicinal products in a clinical trial.
An Expert Working Group has completed a review into how the potential risks associated with antidepressant medicines are communicated to patients
As with any medicine, the MHRA will keep the safety and effectiveness of mirdametinib under close review.
The MHRA has reviewed the warnings regarding addiction, dependence, withdrawal, and tolerance for gabapentin, pregabalin, benzodiazepines, and z-drugs. The findings (detailed in the Public Assessment Report) were that it was necessary to strengthen these warnings in the product information and...
Statistics on the number of patients, including females of child bearing age, prescribed Topiramate.
Summary of the latest safety advice for medicines and medical device users
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