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SOLIRIS (Alexion Pharmaceuticals Australasia Pty Ltd)
Product name
SOLIRIS
Date registered
Evaluation commenced
Decision date
Approval time
115 working days (255)
Active ingredients
eculizumab
Registration type
EOI
Indication
SOLIRIS (intravenous infusion) is indicated for the treatment of patients with:
- Paroxysmal Nocturnal Haemoglobinuria (PNH) to reduce haemolysis.
- atypical Haemolytic Uraemic Syndrome (aHUS).
- Adult patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody-positive.
SOLIRIS is not intended for acute treatment of a NMOSD relapse.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.