MHRA updates product information regarding the very rare risk of non-arteritic anterior ischemic optic neuropathy (NAION) in patients taking semaglutide.
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The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
Guidance: AI Airlock Sandbox Pilot Programme Report
The MHRA’s AI Airlock pilot phase ran between April 2024 and March 2025. This report does not constitute formal MHRA guidance.
Research: Review of risk minimisation for disabling and potentially long-lasting/irreversible side effects associated with fluoroquinolone antibiotics
Public Assessment Report on the review of risk minimisation for fluoroquinolone antibiotics.
MHRA welcomes Professor Jonathan Benger CBE as new CEO of NICE
Professor Benger’s leadership comes at a pivotal time as the MHRA and NICE deepen collaboration
Class 3 Medicines Recall: Activase Pharmaceuticals Limited, Prednisolone 5mg Soluble Tablets, EL(25)A/54
Activase Pharmaceuticals Limited is recalling two batches of Prednisolone 5mg Soluble Tablets as a precautionary measure due to a limited number of reports of blister pockets becoming swollen over time.
Class 4 Medicines Defect Notification: Flamingo Pharma UK Ltd, Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets, EL(25)A/52
Flamingo Pharma UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information.