BIIB CHMP opinion: Thursday, September 17, 2026

Variation type II · Skyclarys · Update of sections 4.8 and 5.1 of the SmPC in order to update clinical safety and efficacy information, based on final results from the open-label extension phase of the Phase 2 Study 408-C-1402; this is a Phase 2 study of the safety, efficacy, and pharmacodynamics of

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