DUPIXENT

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

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 more about Dupilumab

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
DUPIXENT 300 mg Solution for injection	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
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)
AU	Pharmaceutical Benefits Scheme	12291X, 12292Y, 12293B, 12294C, 12302L, 12309W, 12310X, 12313C, 12316F, 12318H
BR	Câmara de Regulação do Mercado de Medicamentos	502818030076002, 502818030076102, 576720020052517, 576720020052617, 576720020052707
CA	Health Products and Food Branch	02470365, 02492504
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	152-MBE-0320, 222-MBE-1221
EE	Ravimiamet	1753927, 1753938, 1753949, 1753950, 1796171, 1796182, 1796193, 1796205, 1796216, 1796227, 1796238, 1796249, 1818468, 1818479, 1818480, 1818491, 1879601, 1879612
ES	Centro de información online de medicamentos de la AEMPS	1171229006, 1171229018
FI	Lääkealan turvallisuus- ja kehittämiskeskus	030364, 042612, 132633, 471531
FR	Base de données publique des médicaments	64039311, 64423080, 64627916, 66004227
GB	Medicines & Healthcare Products Regulatory Agency	349519, 368265, 374250, 380125, 380132
HK	Department of Health Drug Office	65961, 66635
IE	Health Products Regulatory Authority	89072, 89073, 89074, 89075
IL	מִשְׂרַד הַבְּרִיאוּת	8245, 8878
JP	医薬品医療機器総合機構	4490405G1024, 4490405G2020
LT	Valstybinė vaistų kontrolės tarnyba	1084164, 1084165, 1084166, 1084167, 1084168, 1084169, 1084170, 1084171, 1087902, 1087903, 1087905, 1087906, 1087908, 1087909, 1087910, 1087911, 1088994, 1088995, 1088996, 1088997
NL	Z-Index G-Standaard, PRK	148474, 197874, 201472, 201529
PL	Rejestru Produktów Leczniczych	100392280, 100421106, 100427379
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W69342001, W69342002, W69343001, W69343002, W69344001, W69345001, W69345002
SG	Health Sciences Authority	15675P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699809951129, 8699809951136, 8699809951143, 8699809951150, 8699809951167, 8699809951174, 8699809951181, 8699809951198
US	FDA, National Drug Code	0024-5914, 0024-5915, 0024-5916, 0024-5918
ZA	Health Products Regulatory Authority	51/13.12/0879