ROG.SW CHMP opinion: Thursday, September 17, 2026

Variation type II · Alecensa · Update of sections 4.2, 4.4, and 4.8 of the SmPC in order to add dose modification guidance, a warning and precaution, and an adverse drug reaction of hypertriglyceridemia based on cumulative review from clinical trials and postmarketing datasources; the Package Leafle

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