KOSELUGO (Alexion Pharmaceuticals Australasia Pty Ltd)
Product name
KOSELUGO
Date registered
Evaluation commenced
Decision date
Approval time
166 (255 working days)
Active ingredients
selumetinib sulfate
Registration type
EOI
Indication
KOSELUGO is indicated for the treatment of adult and paediatric patients aged 2 years and older, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).