FABHALTA

This brand name is authorized in United States. It is also authorized in Austria, France, Lithuania, Romania.

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 more about Iptacopan

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
FABHALTA Hard capsule	MPI, US: SPL/PLR	FDA, National Drug Code (US)
FABHALTA Hard capsule	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
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)
FR	Base de données publique des médicaments	62501139
LT	Valstybinė vaistų kontrolės tarnyba	1099873, 1099874, 1099875
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W70393001, W70393002, W70393003
US	FDA, National Drug Code	0078-1189