SNY CHMP opinion: Thursday, September 17, 2026
Variation type II · Cerdelga · Update of sections 4.8 and 5.1 of the SmPC in order to include the long-term data from the completed study EFC13738 (ELIKIDS). This is an interventional, open label study to evaluate pharmacokinetics, safety and efficacy of eliglustat in pediatric patients with Gaucher
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