Safety signals, PRAC recommendations, DHPCs, Drug Safety Update, MedWatch and risk minimisation.
Certain lots of Fresenius Kabi Canada's anticoagulant sodium citrate 4g/100mL have manufacturing-related leak defects; Health Canada advises bag-by-bag checks rather than withdrawal.
Italy's medicines agency found no medicine qualifying for innovative status in the October 2026 review, but released reports on Ezmekly and Pedmarqsi, which both had negative outcomes.
The European Commission says it and Canada are intensifying joint work on medical countermeasures for health-emergency preparedness and response, though the announcement sets out no detailed measures.
BASG and AGES join the 11th international campaign urging reporting of suspected side effects, citing 14,528 Austrian pharmacovigilance reports in 2025 and a changed counting method.
The agency has issued Appendix V of the QRD documentation, covering the standard statement and contact details for reporting suspected adverse reactions; the changes are not specified.
B. Braun says a missed solvent step during assembly left the dialyzer connector inadequately bonded on three lots, risking leaks, blood loss and air entry during haemodialysis.
The EMA's safety committee will weigh the benefits and risks of the flupentixol/melitracen combination after Belgium raised concerns about severe, long-lasting and possibly irreversible side effects.
Portugal's medicines authority is taking part in the international campaign running 2–8 November 2026 under a slogan telling people not to ignore suspected adverse drug reactions.
JAZMP has published a DHPC urging careful visual inspection of Caelyx 2 mg/ml vials after some batches were found with incorrectly crimped aluminium seals.
The Slovak medicines authority is backing the 2–8 November global campaign with the message not to ignore side effects, and has restated how suspected reactions can be reported.
The Czech regulator is backing the Uppsala Monitoring Centre campaign, running 2–8 November, which encourages patients and health professionals to report suspected adverse drug reactions.
The agency has widened its 2026 essay competition to pharmacy students and is urging Yellow Card reports on medicines and devices, with low reporting rates for AI-enabled devices flagged.
Germany's two medicines authorities join the international 2–8 November campaign calling on professionals and patients to report suspected side effects so risks are spotted earlier.
Four lots of the heparin-induced thrombocytopenia antibody assay show negative bias that routine calibration and quality control may miss, and a supply interruption is expected.
AIFA says the EMA safety committee opened a review of hypersensitivity reports linked to immunoglobulin batches and a separate review of Deanxit over serious neurological and psychiatric effects.
EMA's safety committee opened a referral on flupentixol/melitracen and a review of hypersensitivity clusters across all human normal immunoglobulin medicines at its October meeting.
The EMA has published the single assessment outcome for gliclazide periodic safety update reports, with the marketing authorisations to be maintained, alongside a list of nationally authorised products.
The European Medicines Agency has released the result of a periodic safety update report single assessment for tenoxicam, with the regulatory outcome listed as maintenance.
The EMA has posted the single assessment of periodic safety update reports for nitrofurantoin and nitrofurantoin/pyridoxine hydrochloride, with a maintenance outcome and a list of nationally authorised products.
The EU regulator has posted the single assessment outcome for cystine / pyridoxine hydrochloride, recording a 'maintenance' result for the nationally authorised products concerned.
The European Medicines Agency has issued a list of centrally authorised medicines whose product information has been changed for safety reasons, dated 30 October 2026.
The agency's single assessment of periodic safety update reports for aprotinin ends with a 'maintenance' outcome, and a list of nationally authorised products has been published.
The EMA has published the outcome of the nicorandil periodic safety update report single assessment, PSUSA/00002152/202602, with a regulatory outcome of 'maintenance'.
The EMA has published the single-assessment outcome for cyproterone acetate/estradiol valerate under procedure PSUSA/00000907/202603, with a regulatory outcome of 'maintenance'.
The EMA has published the single assessment outcome for furazidine (PSUSA/00011098/202602), with the regulatory outcome listed as maintenance of existing authorisations.
PRAC is assessing the flupentixol/melitracen combination after the Belgian agency raised concerns over severe, lasting movement, memory and thinking side effects and the rationale for combining the two substances.
The European Medicines Agency has released the result of a periodic safety update report single assessment for rabies vaccine, recording a regulatory outcome of 'maintenance'.
The European Medicines Agency has released the single assessment outcome for perchlorates, recording a 'maintenance' result for the active substance under procedure PSUSA/00002486/202603.
The EMA has published the outcome of a periodic safety update report single assessment for diclofenac sodium and orphenadrine citrate, with a regulatory outcome of maintenance.
The EU regulator's single assessment of periodic safety update reports for the dimeticone and guaiazulene combination ends with a 'maintenance' outcome, and a list of nationally authorised products has been published.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.