XOLAIR

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

Active ingredients

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

1 Omalizumab UNII 2P471X1Z11 - OMALIZUMAB

Omalizumab is a recombinant DNA-derived humanised monoclonal antibody that selectively binds to human immunoglobulin E (IgE). Omalizumab binds to IgE and prevents binding of IgE to FcεRI (high-affinity IgE receptor) on basophils and mast cells, thereby reducing the amount of free IgE that is available to trigger the allergic cascade. Treatment of atopic subjects with omalizumab resulted in a marked down-regulation of FcεRI receptors on basophils. Read about Omalizumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
XOLAIR 75mg Solution for injection in pre-filled syringe	European Medicines Agency (EU)	MPI, EU: SmPC
XOLAIR 150mg Solution for injection in pre-filled syringe	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
R03DX05	Omalizumab	R Respiratory system → R03 Drugs for obstructive airway diseases → R03D Other systemic drugs for obstructive airway diseases → R03DX Other systemic drugs for obstructive airway diseases
Discover more medicines within R03DX05

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): 10109C, 10110D, 10118M, 10122R, 10956P, 10967F, 10968G, 10973M, 11163M, 11168T, 11175E, 11176F, 11824H, 11825J, 11826K, 11828M, 11835X, 11840E, 11846L, 11864K, 11932B, 11945Q, 11946R, 11950Y, 11952C, 11953D, 11958J, 11962N
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 526517080090107, 526517080090207, 526518060093203, 526525701155210
Country: CA	Health Products and Food Branch	Identifier(s): 02260565, 02459787, 02459795
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 28499-05-08
Country: EE	Ravimiamet	Identifier(s): 1221040, 1221051, 1304929, 1304930, 1461079, 1461080, 1461091, 1461103, 1461114, 1461125
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 05319005, 05319008
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 028257, 028268
Country: FR	Base de données publique des médicaments	Identifier(s): 61971520, 62877141
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 186671, 186674
Country: HK	Department of Health Drug Office	Identifier(s): 54330, 65301, 66276
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 4966
Country: IT	Agenzia del Farmaco	Identifier(s): 036892014, 036892026, 036892038, 036892040, 036892053, 036892065, 036892077, 036892089, 036892091, 036892103, 036892115, 036892127, 036892139, 036892141, 036892154, 036892166, 036892178, 036892180, 036892192, 036892204, 036892216, 036892228, 036892230, 036892242, 036892255, 036892267, 036892279, 036892281, 036892293
Country: JP	医薬品医療機器総合機構	Identifier(s): 2290400D1033, 2290400G1021, 2290400G2028
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1031422, 1031423, 1031424, 1031425, 1037144, 1037145, 1037146, 1037147, 1037148, 1037149, 1087014
Country: NL	Z-Index G-Standaard	Identifier(s): 15467147
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 79324, 95354, 95362
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 17612, 17613, 9777
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100118840, 100124390, 100210987, 100210993
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64465001, W64465002, W64465003, W64466001, W65486001, W65486002, W65486003, W65487001, W65487002, W65487003
Country: SG	Health Sciences Authority	Identifier(s): 13212P, 13213P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 10333011H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699504270204, 8699504270211
Country: US	FDA, National Drug Code	Identifier(s): 50242-040, 50242-214, 50242-215
Country: ZA	Health Products Regulatory Authority	Identifier(s): 55/34/0713, 55/34/0714, A39/34/0310, A39/34/0311