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Four medicine safety updates from Roszdravnadzor and Swissmedic

  • 01-10-2026
  • Posted by: Eldaniz Hasanov
  • Category: Regulatory Updates
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On 1 October 2026, PharmExpert identified four new or revised official medicine-safety materials after the previous checkpoint. They may be relevant to QPPV, LQPPV and LPPV professionals assessing local risks, regulatory obligations and risk-minimisation measures.

Roszdravnadzor: Epkinly (epcoritamab)

Letter No. 02I-1130/26 introduces a patient card addressing cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome (ICANS). It lists symptoms requiring urgent medical attention and advises patients to carry the card. Official Roszdravnadzor page.

Roszdravnadzor: Topalepsin (topiramate)

Letter No. 02I-1131/26 provides materials for healthcare professionals and women of childbearing potential on congenital-malformation, fetal-growth and neurodevelopmental risks. Measures include pregnancy testing, effective contraception, annual review and specific management if pregnancy occurs. Official Roszdravnadzor page.

Roszdravnadzor: Losartan-Xantis recall

Letter No. 02I-1132/26 reports the recall of Losartan-Xantis 50 mg lot 961125. Identification data for that lot were applied to some secondary packs of Meloxicam-Xantis 15 mg. The official letter requests withdrawal and measures to prevent harm to life and health. Official Roszdravnadzor page.

Swissmedic: Safety Updates effective 1 October

The updated official list contains 22 product-information changes, including new adverse reactions, interactions, contraindications and precautions for apixaban, bictegravir, caspofungin, CFTR modulators, ciltacabtagene autoleucel, clozapine, domperidone, tezepelumab, tranexamic acid and other substances. Swissmedic Safety Updates.

Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on the official Roszdravnadzor communications dated 30 September 2026 and the Swissmedic list effective 1 October 2026, and current as of 1 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 a 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, the regulators’ instructions and the approved product information.