List of Field Safety Notices from 29 December 2025 to 2 January 2026.
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Guidance: Early Access to Medicines Scheme: Overview
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeutics.
Class 4 Medicines Defect Notification: Olmesartan medoxomil 10mg film-coated tablets, Jubilant Pharmaceuticals NV, EL(25)A/37
Jubilant Pharmaceuticals NV has informed the MHRA that the Patient Information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL.
Register medical devices to place on the market
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
Clinical trials regulations: transitional arrangements
Guidance on transitional arrangements for applying for clinical trial approval.
Class 4 Medicines Defect Notification: Viatris Products Ltd, Arixtra solution for injection, pre-filled syringes, EL(26)A/04
Viatris has received reports of brown discolouration and blockage in the needle of pre-filled syringes of Arixtra. This quality defect is related to oxidation of the syringe needle.
Mesalazine and idiopathic intracranial hypertension
Idiopathic intracranial hypertension (IIH) has been very rarely reported in patients treated with mesalazine. Following a recent review, warnings for IIH are being added to the product information for all mesalazine products.