New safety measures for Tysabri, macitentan, Remsima and GLP-1 medicines

Roszdravnadzor published four materials. Updated Tysabri materials address PML risk minimisation, JCV stratification and MRI monitoring. A macitentan patient card covers pregnancy prevention, anaemia and liver monitoring. Circulation of Paracetamol 500 mg lot 2210424 and Acetylsalicylic acid 500 mg lot 130824 was terminated for dissolution and assay nonconformity, respectively, with withdrawal and destruction.

Swissmedic stated that the new IV Remsima 100/350 mg concentrate contains sorbitol and is contraindicated in hereditary fructose intolerance. HSA reported serious reactions linked to GLP-1 medicines and unapproved peptides obtained through unauthorised channels.

Sources: Tysabri, macitentan, paracetamol, acetylsalicylic acid, Remsima, HSA.

Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on the official Roszdravnadzor communications dated 23–24 September 2026 and Swissmedic and HSA communications dated 25 September 2026. It is not medical or legal advice, does not replace the official sources, and does not imply wrongdoing by the manufacturer/marketing authorisation holder or a quality concern affecting the 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.