Is Pegunigalsidase alfa authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Pegunigalsidase alfa: Elfabrio.

Active substance

Pegunigalsidase alfa

EMA 1
Health Canada 2

EMA European Union — centrally authorised medicines

Elfabrio Chiesi Farmaceutici S.p.A · Authorised · authorised 4 May 2023 · ATC A16AB20

Therapeutic indication (EMA)

Elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease (deficiency of alpha-galactosidase).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ELFABRIO	02563568	5 MG / 2.5 ML	SOLUTION · INTRAVENOUS	CHIESI FARMACEUTICI S.P.A.
ELFABRIO	02563576	20 MG / 10 ML	SOLUTION · INTRAVENOUS	CHIESI FARMACEUTICI S.P.A.

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.