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The MHRA will introduce a patient alert card to increase awareness among men taking finasteride about potential psychiatric and sexual side effects
If a patient reports persistent symptoms when switching between different levothyroxine tablet formulations, consider consistently prescribing a specific product known to be well tolerated by the patient. If symptoms or poor…
Guidance on managing and using bed rails safely.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines
Information for healthcare professionals and the public about the Pfizer/BioNTech vaccine.
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
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9 May 2024) launched AI Airlock, its new regulatory sandbox for AI as a Medical Device (AIaMD).
Report a problem ('adverse incident') with a medical device or medicine to MHRA using the Yellow Card Scheme
Details of the Yellow Card scheme, which is the system for recording adverse incidents with medicines and medical devices in the UK.
The tighter controls being introduced to minimise risk of overuse and or addiction of painkillers containing codeine or dihydrocodeine.
Systemic fluoroquinolones must now only be prescribed when other commonly recommended antibiotics are inappropriate. This follows a review by the MHRA which looked at the effectiveness of current measures to reduce the ident…
List of Field Safety Notices from15 to 19 April 2024.
People are urged to seek advice from healthcare professionals if they feel they have become dependent on or addicted to codeine linctus.
Marketing authorisations granted in 2024
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Information about new applications, post-licensing, advertising, product information and fees.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
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