pegunigalsidase alfa

This medicine is authorised for use in the European Union.


Elfabrio is a medicine used in adults to treat Fabry disease, a rare inherited disorder. Patients with Fabry disease do not have enough of an enzyme, called alpha-galactosidase A, that normally breaks down a fatty substance called globotriaosylceramide (Gb3). If the enzyme is not present, Gb3 cannot be broken down and it builds up in the organs, such as the kidney and heart, causing kidney failure and heart problems.

Elfabrio contains the active substance pegunigalsidase alfa.

This EPAR was last updated on 25/05/2023

Authorisation details

Product details
Agency product number
Active substance
Pegunigalsidase alfa
International non-proprietary name (INN) or common name
pegunigalsidase alfa
Therapeutic area (MeSH)
Fabry Disease
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Chiesi Farmaceutici S.p.A
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Via Palermo 26/A
43122 Parma

Product information

Elfabrio - EMEA/H/C/005618 -

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

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

Assessment history

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