The Priority Review

Approvals Brief

CHMP recommends marketing authorization for Ruxolitinib Krka

On 12 November 2026 the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for Ruxolitinib Krka, intended for the treatment of myelofibrosis, polycythaemia vera and graft-versus-host disease. The generic will be available as 5 mg, 10 mg, 15 mg and 20 mg tablets.

Primary source

EMA medicine page (CHMP opinion), November 13, 2026

Ruxolitinib Krka (ruxolitinib): EMA CHMP opinion

Read the source ema.europa.eu

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