DUPIXENT

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

Active ingredients

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

1 Dupilumab UNII 420K487FSG - DUPILUMAB

Dupilumab is a recombinant human IgG4 monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling. Dupilumab inhibits IL-4 signaling via the Type I receptor (IL-4Rα/γc), and both IL-4 and IL-13 signaling through the Type II receptor (IL-4Rα/IL-13Rα). IL-4 and IL-13 are major drivers of human type 2 inflammatory disease, such as atopic dermatitis, asthma, and CRSwNP. Blocking the IL-4/IL-13 pathway with dupilumab in patients decreases many of the mediators of type 2 inflammation. Read about Dupilumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
DUPIXENT 300 mg Solution for injection	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
D11AH05		D Dermatologicals → D11 Other dermatological preparations → D11A Other dermatological preparations → D11AH Agents for dermatitis, excluding corticosteroids
Discover more medicines within D11AH05

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 12291X, 12292Y, 12293B, 12294C, 12302L, 12309W, 12310X, 12313C, 12316F, 12318H
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 502818030076002, 502818030076102, 576720020052517, 576720020052617, 576720020052707
Country: CA	Health Products and Food Branch	Identifier(s): 02470365, 02492504
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 152-MBE-0320, 222-MBE-1221
Country: EE	Ravimiamet	Identifier(s): 1753927, 1753938, 1753949, 1753950, 1796171, 1796182, 1796193, 1796205, 1796216, 1796227, 1796238, 1796249, 1818468, 1818479, 1818480, 1818491, 1879601, 1879612
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1171229006, 1171229018
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 030364, 042612, 132633, 471531
Country: FR	Base de données publique des médicaments	Identifier(s): 64039311, 64423080, 64627916, 66004227
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 349519, 368265, 374250, 380125, 380132
Country: HK	Department of Health Drug Office	Identifier(s): 65961, 66635
Country: IE	Health Products Regulatory Authority	Identifier(s): 89072, 89073, 89074, 89075
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8245, 8878
Country: JP	医薬品医療機器総合機構	Identifier(s): 4490405G1024, 4490405G2020
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1084164, 1084165, 1084166, 1084167, 1084168, 1084169, 1084170, 1084171, 1087902, 1087903, 1087905, 1087906, 1087908, 1087909, 1087910, 1087911, 1088994, 1088995, 1088996, 1088997
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 148474, 197874, 201472, 201529
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100392280, 100421106, 100427379
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W69342001, W69342002, W69343001, W69343002, W69344001, W69345001, W69345002
Country: SG	Health Sciences Authority	Identifier(s): 15675P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699809951129, 8699809951136, 8699809951143, 8699809951150, 8699809951167, 8699809951174, 8699809951181, 8699809951198
Country: US	FDA, National Drug Code	Identifier(s): 0024-5914, 0024-5915, 0024-5916, 0024-5918
Country: ZA	Health Products Regulatory Authority	Identifier(s): 51/13.12/0879