GALD.SW CHMP opinion: Thursday, September 17, 2026
Variation type II · Nemluvio · A grouped application comprised of two Type II Variations, as follows: C.I.4: Update of sections 4.8 and 5.1 of the SmPC in order to update clinical safety and efficacy information based on interim results from the ARCADIA long-term extension (LTE) study (RD.06.SIR.11
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