AZN CHMP opinion: Thursday, September 17, 2026
Variation type II · Koselugo · A grouped application consisting of: C.4: Update of sections 4.4, and 4.8 of the SmPC in order to include revised information on the retinal disorders based on review of all available safety data. The RMP version 5.2 has also been submitted. C.4: Update of sections 4.
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