Jun. 16 at 3:21 PM
$PLX Chiesi is updating the Summary of Product Characteristics (SmPC) and Package Leaflet (patient information). The EMA might have requested adjustments to the SmPC wording, additional clarifications, or alignment with their guidelines. For example, they could have asked for more precise language about how to administer the new regimen, patient monitoring requirements, or how to handle side effects. The “updates” to the drug’s official information (SmPC) mentioned now are probably just fine-tuning— most likely to make the instructions clearer or adding a note about potential side effects based on feedback from the EMA. It’s also possible they added some newer study results to make their case stronger, but doesn’t mean the the dosing plan is going to change. Part of the normal process to get the new dosing approved and seems things are still on track for the approval. https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-16-19-june-2025_en.pdf
