BIIB CHMP opinion: Thursday, July 23, 2026

Variation type II · Skyclarys · Update of sections 4.6 and 5.2 of the SmPC in order to update information on lactation, based on results from the phase 1 study 296HV101; this is an open-label, single dose study to assess the breast milk and plasma pharmacokinetics of omaveloxolone in healthy lactati

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