ULTOMIRIS

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

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.
	Read more about Ravulizumab

Medication package inserts

Below package inserts are available for further reading:

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