MHRA updates product information regarding the very rare risk of non-arteritic anterior ischemic optic neuropathy (NAION) in patients taking semaglutide.
Similar Posts
Guidance: Updates to CIR 520/2012 – Information for UK Marketing Authorisation Holders
This guidance clarifies the expectations on the application of the further pharmacovigilance provisions set out within the updated CIR 520/2012 for UK authorised products.
Find product information about medicines
How to get information including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
Field Safety Notices: 13 to 17 October 2025
List of Field Safety Notices from 13 to 17 October 2025.
Guidance: Borderline products: medical devices and other products
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Class 4 Medicines Defect Notification: Special Concept Development UK Limited, Baclofen 10mg Tablets, EL(25)A/51
Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for the batches listed in this notification do not contain the correct safety information.
Profemur Cobalt Chrome Modular Neck Hip Replacements: Higher than anticipated risk of revision surgery, metal-wear effects and component fracture (DSI/2025/005)
An MHRA investigation has found increased risks of wear and corrosion, including an increased occurrence of device fracture and revision surgery associated with cobalt chrome-containing Profemur modular neck hip stem components.
