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OXLUMO (Medison Pharma Australia Pty Ltd)
Product name
OXLUMO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
154 (175 working days)
Active ingredients
lumasiran sodium
Registration type
NCE/NBE
Indication
Oxlumo is indicated for the treatment of primary hyperoxaluria type 1 (PH1) in all agegroups.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.