Medicine guide

Xolair

·

  • Prescription status not stated
  • Breathing, airways, allergies and cough
Active substance
Omalizumab
Made by
Novartis Europharm Limited

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

What it is for

  • Allergic asthma Xolair is indicated in adults, adolescents and children (6 to <12 years of age). Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma. Adults and adolescents (12 years of age and older) Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Children (6 to <12 years of age) Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Chronic rhinosinusitis with nasal polyps (CRSwNP) Xolair is indicated as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe CRSwNP for whom therapy with INC does not provide adequate disease control. Chronic spontaneous urticaria (CSU) Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.

From the official label · 2026-09-30 · European Medicines Agency

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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United StatesNo exact match for this strength and form

SpainNo exact match for this strength and form

FranceNo exact match for this strength and form

CanadaNo exact match for this strength and form

NetherlandsNo exact match for this strength and form

SwitzerlandNo exact match for this strength and form

Details

Made byNovartis Europharm Limited
Active substanceOmalizumab
Used inBreathing, airways, allergies and cough
ClassificationR03DX05 · Breathing, airways, allergies and cough
Authorised on2005-10-25
Last updated by the regulator2026-06-08
EMA product numberEMEA/H/C/000606

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.