NOVN.SW CHMP opinion: Thursday, September 17, 2026

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

Variation type II · FABHALTA · A grouped application consisting of: C.4: Update of sections 4.4, 4.5, and 5.2 of the SmPC in order to add drug-drug interaction information based on the results from study CLNP023C12101. This is a Phase 1 study evaluating the effect of multiple oral doses of iptacopa

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