SAPHNELO

This brand name is authorized in Austria, Australia, Canada, Estonia, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United States

Active ingredients

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

1 Anifrolumab UNII 38RL9AE51Q - ANIFROLUMAB

Anifrolumab is a human immunoglobulin G1 kappa monoclonal antibody that binds to subunit 1 of the type I interferon receptor (IFNAR1) with high specificity and affinity. This binding inhibits type I IFN signalling thereby blocking the biologic activity of type I IFNs. Inhibition of type I IFN blocks plasma cell differentiation and normalises peripheral T-cell subsets, restoring the balance between adaptive and innate immunity that is dysregulated in SLE. Read about Anifrolumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
SAPHNELO 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
L04AG11		L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AG Monoclonal antibodies
Discover more medicines within L04AG11

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: CA	Health Products and Food Branch	Identifier(s): 02522845
Country: EE	Ravimiamet	Identifier(s): 1876002
Country: FR	Base de données publique des médicaments	Identifier(s): 61365985
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 9034
Country: IT	Agenzia del Farmaco	Identifier(s): 049964012
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999462A1028
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1094258
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100462345
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W68471001
Country: US	FDA, National Drug Code	Identifier(s): 0310-3040