Xolair

RSS

omalizumab

Authorised
This medicine is authorised for use in the European Union.

Overview

Xolair is used to improve the control of severe persistent asthma caused by an allergy. It is used as an add-on to asthma treatment in patients from 6 years of age when an antibody called immunoglobulin E (IgE) causes the asthma. Xolair must only be used in patients who:

  • have had a positive skin test result for an allergy caused by an allergen (a stimulus that causes an allergy) in the air, such as house dust mites, pollen or mould;
  • have frequent symptoms during the day or waking up during the night;
  • have had many severe asthma attacks (that require rescue treatment with other medicines) despite treatment with high doses of inhaled corticosteroids plus a long-acting inhaled beta2 agonist.

In patients aged 12 years or over, Xolair must only be used if the lung function is less than 80% of normal.

Xolair is also used to treat:

  • chronic (long-term) spontaneous urticaria (itchy rash). It is used as an add-on to existing treatment in patients aged 12 years or over in whom treatment with an antihistamine does not work well enough;
  • severe chronic rhinosinusitis with nasal polyps (inflamed lining of the nose and sinuses with swellings in the nose) in adults. It is used with a corticosteroid given into the nose when the corticosteroid alone does not work well enough.

Xolair contains the active substance omalizumab.

This EPAR was last updated on 24/08/2020

Authorisation details

Product details
Name
Xolair
Agency product number
EMEA/H/C/000606
Active substance
omalizumab
International non-proprietary name (INN) or common name
omalizumab
Therapeutic area (MeSH)
  • Asthma
  • Urticaria
Anatomical therapeutic chemical (ATC) code
R03DX05
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
40
Date of issue of marketing authorisation valid throughout the European Union
25/10/2005
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

31/07/2020 Xolair - EMEA/H/C/000606 - II/0101

Contents

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Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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