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KOSELUGO (AstraZeneca Pty Ltd)
Product name
KOSELUGO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
205 (255 working days)
Active ingredients
selumetinib
Registration type
NCE/NBE
Indication
KOSELUGO (capsule) is indicated for the treatment of paediatric patients aged 2 years and above, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.