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These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Fresenius Kabi Limited have informed the MHRA of a packaging error with specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex and Freeflex PLUS.
Check the tariff classification for surface-active preparation for washing the skin and the hair (gel 2-in-1).
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
How a marketing authorisation holder should report a defect with a veterinary medicine.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and information about the publication of two recent Device Safety Information pages. The article also includes information on a recent National Patient Safety Alert...
Urgent safety updates arising from pharmacovigilance data, including reported adverse events, for veterinary medicines authorised in the UK.
medac GmbH (t/a medac Pharma LLP) is recalling the product for the batch specified in this notification due to particles detected during long-term stability tests.
Neon Healthcare Ltd is recalling the specific batch mentioned in this notification as a precautionary measure.
Fresenius Kabi Limited has informed the MHRA of an error on the infusion bag packaged into the specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex.
Healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hallucinations, anxiety and depression, as well as changes in behaviour and mood. Healthcare professionals...
Product Safety Report for Vixa Skineal Steroid Cream presenting a serious chemical risk.
Besins Healthcare (UK) Ltd has informed the MHRA that a defective pump system was detected in two batches of Oestrogel Pump-Pack 750 micrograms/actuation Gel.
Product Safety Report for PTS Packers and Providers Pvt Surfaz-SN Triple Action Cream presenting a serious chemical risk.
Batches of some products made by Legency Remedies Pvt Ltd have been found to contain a bacteria called Ralstonia pickettii (R. pickettii). All potentially affected batches are being recalled following an MHRA investigation.
Applications received to amend the specification of a patent under sections 27 and 75 before the court and the Office.
Product Safety Report for Fabrique Par Rodis White Secret Unifying Complexion Serum presenting a serious chemical risk.
Product Safety Report for GDK Akagni Skin Toning Cream presenting a serious chemical risk.
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