Omalizumab
Other Systemic Drugs For Obstructive Airway Diseases
Sold as XOLAIR · OMLYCLO
- Drug class
- Other Systemic Drugs For Obstructive Airway Diseases
- Availability
- See label
- Routes
- Subcutaneous
- Markets covered
- 3
- Products on record
- 32
Overview
Omalizumab is an active pharmaceutical ingredient in the Other Systemic Drugs For Obstructive Airway Diseases group (R03DX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 17 | May 29, 2026 |
| CA Canada | Health Canada | 13 | May 1, 2026 |
| EU European Union | EMA | 2 | May 11, 2026 |
GBUnited Kingdom· MHRA
17 products
Uses
Allergic asthma ADCOMFO is indicated in adults, adolescents and children (6 to <12 years of age). 2). Adults and adolescents (12 years of age and older) ADCOMFO 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 inhale corticosteroids, plus a long-acting inhaled beta2-agonist.
Children (6 to <12 years of age) ADCOMFO 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.
CACanada· Health Canada
13 products
Uses
Allergic Asthma XOLAIR (omalizumab) is indicated for adult and pediatric patients (6 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.
• Adults and adolescents (12 years of age and older): XOLAIR has been shown to significantly decrease the incidence of asthma exacerbations and improve control of asthma symptoms in these patients. • Children (6 to <12 years of age): XOLAIR, used as add-on therapy, has been shown to significantly decrease asthma exacerbation rates in children who are inadequately controlled and have a documented history of exacerbation.
Chronic Rhinosinusitis with Nasal Polyposis XOLAIR (omalizumab) is indicated as an add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled by intranasal corticosteroids alone.
EUEuropean Union· EMA
2 products
Uses
Allergic asthma Omlyclo is indicated in adults, adolescents and children (6 to < 12 years of age). 2). Adults and adolescents (12 years of age and older) Omlyclo 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.
3 Children (6 to < 12 years of age) Omlyclo 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.
Drug interactions
Known interactions involving Omalizumab. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL567340018 · revised May 26, 2026
- [2]Health Canada (DPD) · 02260565 · revised November 21, 2025
- [3]European Medicines Agency · EMEA/H/C/005958 · revised May 11, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.