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

Variation type II · Ocrevus · Update of sections 4.4 and 4.8 of the SmPC in order to add a new warning on ‘Liver Injury’ and to add it to the list of adverse drug reactions (ADRs) with frequency ‘rare’, based on a cumulative safety review. The Package Leaflet is updated accordingly. In addition, the

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