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

Variation type II · Glivec · Update of section 4.8 of the SmPC in order to add “bone marrow oedema” to the list of adverse drug reactions (ADRs) with frequency “not known” based on post-marketing data and literature. The Package Leaflet is updated accordingly. In addition, the MAH took the opportuni

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