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These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
How we evaluated pre-exposure prophylactic (preventative) treatments for COVID-19.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and information about the publication of two recent Device Safety Information pages. The article also includes information on a recent National Patient Safety Alert...
Collection of information and guidance for patients and for healthcare professionals on the reproductive risks of valproate and new safety measures introduced to reduce these risks.
Urgent safety updates arising from pharmacovigilance data, including reported adverse events, for veterinary medicines authorised in the UK.
Applications received to amend the specification of a patent under sections 27 and 75 before the court and the Office.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (11 March 2024) approved the medicine etrasimod (Velsipity) to treat people with moderately to severely active ulcerative colitis.
Information about the risks of taking valproate medicines during pregnancy.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (11 March 2024) approved the medicine quizartinib (Vanflyta) to be used alongside chemotherapy as first line treatment for adults who have acute myeloid leukaemia (AML).
Information for patients who have been prescribed Lagevrio (molnupiravir), the COVID-19 oral antiviral medication.
Reported problems with the supply of an animal medicine and the date when the issue is expected to be resolved.
Details of certificates issued under the Special Import System for the top ten imported veterinary medicines 1 April - 30 June 2023.
Details of certificates issued under the Special Import System for the top ten veterinary medicines that were imported 1 Oct - 31 Dec 2023.
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