Xolair

RSS

omalizumab

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

Overview

This is a summary of the European public assessment report (EPAR) for Xolair. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xolair.

This EPAR was last updated on 15/06/2018

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
33
Date of issue of marketing authorisation valid throughout the European Union
25/10/2005
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

31/05/2018 Xolair - EMEA/H/C/000606 - IA/0087

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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 (see section 4.2).

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. Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2).

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.

Assessment history

Changes since initial authorisation of medicine

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