FABHALTA

This brand name is authorized in Lithuania, United States

Active ingredients

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

1 Iptacopan UNII 8E05T07Z6W - IPTACOPAN

Iptacopan is a proximal complement inhibitor that targets Factor B (FB) to selectively inhibit the alternative pathway. Inhibition of FB in the alternative pathway of the complement cascade prevents the activation of C3 convertase and the subsequent formation of C5 convertase to control both C3-mediated extravascular haemolysis (EVH) and terminal complement-mediated intravascular haemolysis (IVH). Read about Iptacopan

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
FABHALTA Hard capsule	European Medicines Agency (EU)	MPI, EU: SmPC
FABHALTA Hard capsule	FDA, National Drug Code (US)	MPI, US: SPL/PLR

Medicine classification

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

ATC code	Group title	Classification
L04AJ08		L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AJ Complement inhibitors
Discover more medicines within L04AJ08

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1099873, 1099874, 1099875
Country: US	FDA, National Drug Code	Identifier(s): 0078-1189