List of Field Safety Notices from 10 to 14 November 2025.
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Class 4 Medicines Defect Notification: Erythromycin Stearate BP 250mg Tablets, Amdipharm UK Ltd, EL(25)A/32
Amdipharm UK Ltd has informed MHRA that the Patient information leaflet (PIL) in the cartons for the batch listed in this notification includes a superseded PIL.
Field Safety Notices: 4 to 8 August 2025
List of Field Safety Notices from 4 to 8 August 2025.
Device specific vigilance guidance: Inferior vena cava (IVC) filters
Guidance for manufacturers of IVC filters. It outlines specific scenarios that should be considered when determining if an incident is reportable.
Policy paper: Rare therapies and UK regulatory considerations
A paper outlining MHRA’s intentions to make it quicker and easier to get rare disease therapies tested, manufactured and approved in the UK.
Concizumab approved to prevent or reduce the frequency of bleeding episodes in people aged 12 years and older with haemophilia A or B with inhibitors
As with any medicine, the MHRA will keep the safety and effectiveness of concizumab under close review.
Decision: Parallel import licences granted in 2026
Parallel import licences granted in 2026.
