ULTOMIRIS

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

Active ingredients

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

1 Ravulizumab UNII C3VX249T6L - RAVULIZUMAB

Ravulizumab is a monoclonal antibody IgG2/4K that specifically binds to the complement protein C5, thereby inhibiting its cleavage to C5a (the proinflammatory anaphylatoxin) and C5b (the initiating subunit of the terminal complement complex [C5b-9]) and preventing the generation of the C5b-9. Ravulizumab preserves the early components of complement activation that are essential for opsonisation of microorganisms and clearance of immune complexes. It is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH). Read about Ravulizumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ULTOMIRIS Solution for injection	FDA, National Drug Code (US)	MPI, US: SPL/PLR
ULTOMIRIS 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
L04AJ02		L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AJ Complement inhibitors
Discover more medicines within L04AJ02

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 232-MBE-0522
Country: EE	Ravimiamet	Identifier(s): 1799466, 1833566, 1833577
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 394543, 411628, 581159
Country: FR	Base de données publique des médicaments	Identifier(s): 61808523, 64265627, 68652991
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 381942, 394856, 394859
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8548
Country: IT	Agenzia del Farmaco	Identifier(s): 048059012, 048059024, 048059036, 048059048
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1088262, 1091501, 1091502
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100423223, 100462352
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W68777001, W68778001
Country: US	FDA, National Drug Code	Identifier(s): 25682-022, 25682-025, 25682-028