AMGN CHMP opinion: Thursday, September 17, 2026

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

Variation type II · Neulasta · Update of sections 4.4, and 4.8 of the SmPC in order to expand an existing warning on aortitis to include medium and large vessel arteritis to further characterize the spectrum of vascular inflammation associated with G-CSF use, and add arteritis to the list of adverse

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