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ULTOMIRIS (Alexion Pharmaceuticals Australasia Pty Ltd)
Product name
ULTOMIRIS
Date registered
Evaluation commenced
Decision date
Approval time
173 working days (255)
Active ingredients
ravulizumab
Registration type
NCE/NBE
Indication
ULTOMIRIS (concentrated solution for intravenous infusion) is indicated for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.