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Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
How investigators and sponsors should manage clinical trials during COVID-19
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
The MHRA will introduce a patient alert card to increase awareness among men taking finasteride about potential psychiatric and sexual side effects
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Torrent Pharma (UK) Limited is recalling certain batches of Ramipril 1.25mg tablets as a precautionary measure due to these batches having a low assay and high related substances test results after their release to the market.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
The review of the safety of isotretinoin has concluded.
Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion due to the benefit-risk balance of Adakveo no longer being considered favourable by the MHRA.
The MHRA has approved the combined antibiotic cefepime/enmetazobactam (Exblifep 2 g/0.5 g powder for concentrate for solution for infusion)
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care .
How to apply for marketing authorisation via this new procedure.
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
Submissions related to human medicines need to be submitted directly to the MHRA.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (7 March 2024) approved the medicine rozanolixizumab (Rystiggo) to treat adults with generalised myasthenia gravis, an autoimmune disease that causes muscle weakness, which can affect multiple muscle groups throughout the...
Further measures to be introduced to ensure patients who are prescribed montelukast for the treatment of asthma are informed of the risk of neuropsychiatric reactions
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