BIIB CHMP opinion: Thursday, September 17, 2026

EventCHMP opinion
DateThursday, September 17, 2026
MarketUS listing
SourceEMA CHMP · confidence 90% · primary source ↗

Variation type II · Plegridy · Update of sections 4.8 and 5.1 of the SmPC in order to update paediatric information on safety and efficacy based on week 96 results from study 105MS306; this is an open-label, randomized, multicenter, active-controlled, parallel-group study to evaluate the safety, tol

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