XOLAIR

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, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

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) and lowers free IgE levels. The antibody is an IgG1 kappa that contains human framework regions with the complementary-determining regions of a murine parent antibody that binds to IgE.
	Read more about Omalizumab

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
XOLAIR 75 mg Solution for injection	MPI, EU: SmPC	European Medicines Agency (EU)
XOLAIR 150 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
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)
AU	Pharmaceutical Benefits Scheme	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
BR	Câmara de Regulação do Mercado de Medicamentos	526517080090107, 526517080090207, 526518060093203, 526525701155210
CA	Health Products and Food Branch	02260565, 02459787, 02459795
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	28499-05-08
EE	Ravimiamet	1221040, 1221051, 1304929, 1304930, 1461079, 1461080, 1461091, 1461103, 1461114, 1461125
ES	Centro de información online de medicamentos de la AEMPS	05319005, 05319008
FI	Lääkealan turvallisuus- ja kehittämiskeskus	028257, 028268
FR	Base de données publique des médicaments	61971520, 62877141
GB	Medicines & Healthcare Products Regulatory Agency	186671, 186674
HK	Department of Health Drug Office	54330, 65301, 66276
IL	מִשְׂרַד הַבְּרִיאוּת	4966
IT	Agenzia del Farmaco	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
JP	医薬品医療機器総合機構	2290400D1033, 2290400G1021, 2290400G2028
LT	Valstybinė vaistų kontrolės tarnyba	1031422, 1031423, 1031424, 1031425, 1037144, 1037145, 1037146, 1037147, 1037148, 1037149, 1087014
NL	Z-Index G-Standaard	15467147
NL	Z-Index G-Standaard, PRK	79324, 95354, 95362
NZ	Medicines and Medical Devices Safety Authority	17612, 17613, 9777
PL	Rejestru Produktów Leczniczych	100118840, 100124390, 100210987, 100210993
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64465001, W64465002, W64465003, W64466001, W65486001, W65486002, W65486003, W65487001, W65487002, W65487003
SG	Health Sciences Authority	13212P, 13213P
TN	Direction de la Pharmacie et du Médicament	10333011H
TR	İlaç ve Tıbbi Cihaz Kurumu	8699504270204, 8699504270211
US	FDA, National Drug Code	50242-040, 50242-214, 50242-215
ZA	Health Products Regulatory Authority	55/34/0713, 55/34/0714, A39/34/0310, A39/34/0311