ELFABRIO

This brand name is authorized in Austria, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom, United States

Active ingredients

The drug ELFABRIO contains one active pharmaceutical ingredient (API):

1 Pegunigalsidase alfa UNII 8M7V7Q6537 - PEGUNIGALSIDASE ALFA

The active substance of pegunigalsidase alfa is pegunigalsidase alfa. Pegunigalsidase alfa is a pegylated recombinant form of human α-galactosidase-A. The amino acid sequence of the recombinant form is similar to the naturally occurring human enzyme. Pegunigalsidase alfa supplements or replaces α-galactosidase-A, reducing the amount of accumulation of globotriaosylceramide (Gb3) and globotriaosylsphingosine (Lyso-Gb3). Read about Pegunigalsidase alfa

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ELFABRIO Concentrate for solution for infusion	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
A16AB20		A Alimentary tract and metabolism → A16 Other alimentary tract and metabolism products → A16A Other alimentary tract and metabolism products → A16AB Enzymes
Discover more medicines within A16AB20

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: EE	Ravimiamet	Identifier(s): 1898714, 1898725, 1898736
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 053888, 558946
Country: FR	Base de données publique des médicaments	Identifier(s): 66425258
Country: IT	Agenzia del Farmaco	Identifier(s): 050667017, 050667029, 050667031
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1097091, 1097092, 1097093
Country: US	FDA, National Drug Code	Identifier(s): 10122-160