Eight new medicine-safety updates from Russia, Japan, France and Spain

Official communications published on 7–8 October produced eight new packages: two Roszdravnadzor additional risk-minimisation packages for eculizumab and zoledronic acid; circulation termination/recall actions for batches of Bronchorus, ketorolac and simethicone; a PMDA/MHLW reciprocal contraindication for anamorelin and posaconazole; ANSM’s third GLP-1 agonist pharmacovigilance report; and AEMPS’s withdrawal of El Toro containing undeclared sildenafil.

QPPVs, LQPPVs and LPPVs should assess local applicability of the risk-minimisation materials, affected-batch exposure and supply chains, implementation of the anamorelin/posaconazole contraindication, and local signals involving GLP-1 agonist misuse, pancreatitis, nutritional complications and drug interactions.

Official sources: Roszdravnadzor 01И-1157/26; 01И-1156/26; 01И-1149/26 — Bronchorus; 01И-1150/26 — ketorolac; 01И-1151/26 — simethicone; PMDA/MHLW; ANSM; AEMPS.

Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on official communications issued by Roszdravnadzor, PMDA/MHLW, ANSM and AEMPS on 7–8 October 2026 and current as of 8 October 2026. It is not medical or legal advice, does not replace the official sources, and does not imply wrongdoing by any manufacturer/marketing authorisation holder or a quality concern affecting any company’s entire product portfolio. Company and product names are used only to identify the official materials accurately. Decisions should be based on the primary sources, regulators’ instructions and the approved product information.