Is Pegcetacoplan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Pegcetacoplan, including Empaveli 1080 mg per 20 ml (54 mg/ml, Solution for infusion, SAR 16289.60); Empaveli 1080 mg per 20 ml 8 vials (54 mg/ml, Solution for infusion, SAR 130364.90).

Is Pegcetacoplan approved by the US FDA?

Drugs@FDA lists 2 application product lines for Pegcetacoplan, including EMPAVELI (Prescription); SYFOVRE (Prescription).

Is Pegcetacoplan authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Pegcetacoplan: Aspaveli.

Are there safety signals or safety updates for Pegcetacoplan?

US FDA: 2 entries (latest 2026-08-20).

Active substance

Pegcetacoplan

SFDA 2
US FDA 2
EMA 2
Health Canada 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Empaveli 1080 mg per 20 ml	54 mg/ml	Solution for infusion · Subcutaneous use	1 Vial	SAR 16289.60	NCE · Prescription	SWEDISH ORPHAN BIOVITRUM INTERNATIONAL AB	Valid
Empaveli 1080 mg per 20 ml 8 vials	54 mg/ml	Solution for infusion · Subcutaneous use	8 Vial	SAR 130364.90	NCE · Prescription	SWEDISH ORPHAN BIOVITRUM INTERNATIONAL AB	Valid

Indications — CHI Daman Drug Formulary

PAROXYSMAL NOCTURNAL HEMOGLOBINURIA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
EMPAVELI	1080MG/20ML (54MG/ML)	solution · subcutaneous	APELLIS PHARMS	Prescription	14 May 2021
SYFOVRE	15MG/0.1ML (15MG/0.1ML)	solution · intravitreal	APELLIS PHARMS	Prescription	17 Feb 2023

EMA European Union — centrally authorised medicines

Aspaveli Swedish Orphan Biovitrum AB (publ) · Authorised · authorised 13 Dec 2021 · ATC L04AJ03

Therapeutic indication (EMA)

Aspaveli is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia. Aspaveli is indicated for the treatment of adult and adolescent patients aged 12 to 17 years with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in combination with a renin-angiotensin system (RAS) inhibitor, unless RAS inhibitor treatment is not tolerated or contraindicated.

Syfovre Apellis Europe B.V. · Refused · ATC S01XA31

Therapeutic indication (EMA)

Treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
EMPAVELI	02533294	1080 MG / 20 ML	SOLUTION · SUBCUTANEOUS	SWEDISH ORPHAN BIOVITRUM AB (PUBL)

Safety signals and safety-related labeling changes

US FDA 20 Aug 2026 EMPAVELI — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 20 Dec 2024 SYFOVRE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for pegcetacoplan →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.