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MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 8 July, become the first regulator in the world to approve elinzanetant (Lynkuet) for the treatment of moderate to severe vasomotor symptoms (hot flushes) associated with the menopause.
Standard: Statement of Policy Intent: Early Access to Innovative Medical Devices
The MHRA’s initial plans on an Early Access service, which will be developed further throughout 2025.
Device specific vigilance guidance: Coronary Stents and associated delivery systems
Guidance for manufacturers of coronary stents. It outlines specific scenarios that should be considered when determining if an incident is reportable.
Brensocatib licensed as the first medicine specifically designed to treat non-cystic fibrosis bronchiectasis in patients 12 years and older
As with any medicine, the MHRA will keep the safety and effectiveness of brensocatib under close review.
Cutting-edge personalised treatments, made while you wait, will deliver specialised care to patients more quickly
New regulations effective today will make it faster and easier for cutting-edge cancer treatments and personalised gene therapies to be made right where patients are treated.
Clinical trials for medicines: manage your authorisation, report safety issues
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.