List of Field Safety Notices from 8-12 December 2025
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Class 4 Medicines Defect Notification: Hikma Farmacêutica, Gemcitabine 2g/52.6ml concentrate for solution for infusion, EL(25)A/43
Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions.
Guidance: Borderline products: medical devices and other products
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Class 3 Medicines Recall: Zambon SpA, Emylif 50mg orodispersible film, EL(25)A/47
Zambon SpA is recalling an affected batch as a precautionary measure due to out of specification results for unknown impurities during ongoing stability testing.
Class 2 Medicines Recall: Inhixa 12,000IU (120mg)/0.8mL solution for injection, Maxearn Limited, EL(25)A/27
Maxearn Limited have informed the MHRA that the carton used to package two imported batches of Inhixa have been released to the market with a typographical error on one side of the carton.
Guidance: Report on Adverse Event (AE) reporting in digital mental health technologies (DMHTs) and the development of updates to regulatory guidance
Advice for manufacturers of DMHTs that qualify as software as a medical device (SaMD) on understanding new post marketing surveillance rules and examples of how they apply.
MHRA approves lenacapavir for the prevention of sexually transmitted HIV-1 infection
As with any medicine, the MHRA will keep the safety and effectiveness of lenacapavir under close review.