Summary of the latest safety advice for medicines and medical device users
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Class 4 Medicines Defect Notification: Rayner Pharmaceuticals Limited, Dropodex 0.1% w/v Eye Drops, solution, EL(26)A/10
Rayner Pharmaceuticals limited have informed the MHRA that the batches listed in this notification do not include the concentration of phosphates in the product information.
Consultation on the International Council for Harmonisation Guideline E20 for adaptive clinical trial design
The MHRA is consulting with UK stakeholders to gather feedback and comments on ICH E20, a new international guideline.
Class 4 Medicines Defect Notification: Lexon UK Ltd, Moclobemide 150mg tablets, EL(25)A/50
Lexon UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification is missing important updated safety information.
Falsified Mounjaro KwikPen 15mg pre-filled pens
A falsified version of Mounjaro (tirzepatide) KwikPen 15mg solution for injection has been found supplied through one online pharmacy in the UK. The falsified product is labelled with batch D873576 and applies to Mounjaro KwikPen 15mg solution for injection in pre-filled pen only.
Strengthening collaboration between the MHRA and the Department of Health Northern Ireland
The MHRA and Northern Ireland partners are working together to support innovation, enhance patient safety and ensure people in Northern Ireland benefit from world-class regulation.
Guidance: Medical devices: post-market surveillance requirements
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.