Summary of the latest safety advice for medicines and medical device users
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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.
Class 3 Medicines Recall: Omeprazole 20 mg/15 ml Oral Solution, Glenmark Pharmaceuticals Europe Ltd, EL(25)A/30
Glenmark Pharmaceuticals Europe Ltd is recalling a specific batch of Omeprazole Oral Solution as a precautionary measure due to an investigation following a customer complaint indicating precipitation and discoloration of the product in the bottles.
Vorasidenib approved to treat patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 16th September 2025, approved the medicine vorasidenib (Voranigo).
Guidance: Health Institution Exemption for general medical devices
Guidance for health institutions that manufacture general medical devices under the Health Institution Exemption (HIE).
UK sets out world‑leading pathway for space‑manufactured drugs
Patients could benefit from more effective, higher quality and longer lasting medicines as the UK sets out a clearer route to bring drugs manufactured in space safely to market.
AI tools that could detect diseases earlier selected for next phase of MHRA’s ‘AI Airlock’ programme
Seven emerging AI healthcare technologies have been selected for the second phase of the MHRA’s AI Airlock programme.