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Erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis reported in association with isotretinoin - may result in hospitalisation, disability, life-threatening events, or death.
We have published guidance about the use of remote consultations for pregnancy prevention in women of childbearing potential and monitoring for signs of psychiatric reactions (especially depression) and other safety risks in all patients taking oral retinoid medicines during the...
Isotretinoin should only be prescribed by consultant dermatologist-led teams and dispensed only by a hospital pharmacy.
A patient alert card is being introduced for men taking finasteride to help raise awareness of the risk of psychiatric side effects and sexual dysfunction, including the potential for sexual dysfunction to persist after treatment has stopped. Healthcare professionals are...
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
New online form for applications.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Information for patients, healthcare professionals and developers of new medicines
A summary of recent letters and notifications sent to healthcare professionals about medicines.
The Intellectual Property Office offers different methods of accelerating the processing of your patent application.
How to use an interrupted time series to evaluate your digital health product.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
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