NOVN.SW CHMP opinion: Thursday, September 17, 2026
Variation type II · Luxturna · Submission of the final report from study SPKRPE-PASS, following the request from PRAC in PSUSA/00010742/202507. This is a post-authorization, multicenter, longitudinal, observational safety registry study for patients treated with voretigene neparvovec in US.
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