ELFABRIO

This brand name is authorized in United States. It is also authorized in Austria, Croatia, Estonia, Finland, France, Ireland, Italy, Lithuania, Poland, UK.

Active ingredients

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

1
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 more about Pegunigalsidase alfa

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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

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