Legal status by country
Is Pegcetacoplan legal?
Written by Aaron CuhaReviewed Sep 2026
How Pegcetacoplan is classified in the United States, United Kingdom, Australia and Canada, side by side. Each country has its own page with a direct answer, the regulator's approval status and what the classification means in practice.
All four countries, side by side
| Attribute | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Approved | Approved | Approved | Approved |
| Classification | FDA-approved, prescription only | Licensed for the blood indication only | Registered for the blood indication only | Approved for the blood indication only |
| Note | Two separate approvals for two separate diseases by two separate routes: Empaveli NDA 215014 (14 May 2021, subcutaneous, paroxysmal nocturnal haemoglobinuria and later C3 glomerulopathy) and Syfovre NDA 217171 (17 February 2023, intravitreal, geographic atrophy). | The systemic product is authorised in Europe for paroxysmal nocturnal haemoglobinuria. The intravitreal geographic atrophy product was refused: the European Medicines Agency committee adopted a negative opinion in June 2024 and confirmed it on re-examination in September 2024, on the grounds that slowing lesion growth did not produce a clinically meaningful benefit for patients. | The geographic atrophy product is not available on the same basis as in the United States. Prescription only, specialist use. | Prescription only, specialist use, in haematology rather than ophthalmology. |
US FDA status: FDA-approved twice. Empaveli, NDA 215014, approved 14 May 2021, subcutaneous infusion, for paroxysmal nocturnal haemoglobinuria in adults and now also for C3 glomerulopathy and primary immune-complex membranoproliferative glomerulonephritis from age 12. Syfovre, NDA 217171, approved 17 February 2023, intravitreal injection, for geographic atrophy secondary to age-related macular degeneration. The European Medicines Agency refused the geographic atrophy indication in 2024.. Reviewed Sep 2026.
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General information current as of Sep 2026, not legal advice. Classifications change; confirm with the regulator or a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships.