INCY CHMP opinion: Thursday, July 23, 2026
Variation type II · Pemazyre · A grouped application consisting of two Type II Variations, as follows: C.4: Update of sections 4.4, 4.5, and 4.8 of the SmPC in order to update clinical information based on final results from study INCB 54828-302 (FIGHT-302), listed as a specific obligation in the A
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