Elfabrio
pegunigalsidase alfa
Table of contents
Overview
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.
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List item
Elfabrio : EPAR - Medicine Overview (PDF/95.92 KB) (new)
First published: 08/05/2023
EMA/210775/2023 -
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List item
Elfabrio : EPAR - Risk management plan summary (PDF/262.69 KB) (new)
First published: 08/05/2023
Authorisation details
Product details | |
---|---|
Name |
Elfabrio
|
Agency product number |
EMEA/H/C/005618
|
Active substance |
Pegunigalsidase alfa
|
International non-proprietary name (INN) or common name |
pegunigalsidase alfa
|
Therapeutic area (MeSH) |
Fabry Disease
|
Anatomical therapeutic chemical (ATC) code |
A16AB20
|
Publication details | |
---|---|
Marketing-authorisation holder |
Chiesi Farmaceutici S.p.A
|
Revision |
1
|
Date of issue of marketing authorisation valid throughout the European Union |
04/05/2023
|
Contact address |
Via Palermo 26/A |
Product information
Elfabrio - EMEA/H/C/005618 -
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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).