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KOSELUGO Alexion Pharmaceuticals Australasia Pty Ltd

Product name
KOSELUGO
Accepted date
Apr-2025
Active ingredients
selumetinib sulfate
Proposed indication
KOSELUGO (selumetinib sulfate) is for the treatment of adults and children (aged 2 years and older) with neurofibromatosis type 1, a genetic disorder that causes benign tumors to grow on nerve tissue, various skin changes, and a wide range of other symptoms. For KOSELUGO treatment, patients must also have plexiform neurofibromas, a type of tumour that affects nerves and cannot be removed surgically.
Application type
C (new indication)
Publication date
Apr-2025