The MHRA has received reports describing a positive bias in HbA1c results delivered by the Trinity Biotech Premier Hb9210 HbA1c analyser, which has resulted in patients being incorrectly diagnosed as pre-diabetic or diabetic.
Similar Posts
Field Safety Notices: 24 to 28 November 2025
List of Field Safety Notices from 24 to 28 November 2025.
Class 4 Medicines Defect Notification: Dulcolax Adult 5 mg Gastro-resistant Tablets, Opella Healthcare UK, EL(25)A/26
Opella Healthcare UK LTD has informed the MHRA that there is an error on the artwork for the outer carton of Dulcolax Adult 5mg GR Tablets (packsize 20 count). The dose instruction incorrectly states for use in 12 years and older. These general sale packs are intended for use only in adult patients (18 years and over).
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).
Isotretinoin – changes to prescribing guidance and additional risk minimisation measures
The Commission on Human Medicines (CHM) has endorsed changes to the risk minimisation measures for isotretinoin, following a review of the impact of the measures implemented in 2023. We ask healthcare professionals to review these new measures and supporting materials and integrate them into their clinical practice.
Guidance: Centres of Excellence for Regulatory Science and Innovation (CERSIs)
An initiative to help drive advancements in healthcare, to ensure patients benefit from innovation and new treatments sooner.
Clinical trials for medicines: ending a clinical trial
Guidance on the process for ending a clinical trial.