AMGN CHMP opinion: Thursday, September 17, 2026

EventCHMP opinion
DateThursday, September 17, 2026
MarketUS listing
SourceEMA CHMP · confidence 90% · primary source ↗

Variation type II · LUMYKRAS · Update of section 4.8 of the SmPC in order to delete four renal toxicity adverse drug reactions (ADRs) based on review of safety data; the Package Leaflet is updated accordingly. In addition, the MAH took the opportunity to update the list of local representatives in t

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