SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| XOLAIR 150MG Powder for injection | 150 mg | powder for solution for injection · Subcutaneous use | 1 Vial | SAR 1796.85 | Biological · Prescription | NOVARTIS | Valid |
| Xolair | 150 mg | Solution for injection in pre-filled syringe · Subcutaneous use | 1 Pre-filled syringe | SAR 1796.85 | Biological · Prescription | Novartis Europharm Limited | Valid |
| Xolair | 75 mg | Solution for injection in pre-filled syringe · Subcutaneous use | 1 Pre-filled syringe | SAR 898.40 | Biological · Prescription | Novartis Europharm Limited | Valid |
Indications — CHI Daman Drug Formulary
ASTHMA; SINUSITIS; URTICARIA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| XOLAIR | 150MG/VIAL | vial | GENENTECH | Prescription | 20 Jun 2003 |
| XOLAIR | 75MG/0.5ML; 150MG/ML; 300MG/2ML | syringe | GENENTECH | Prescription | 20 Jun 2003 |
| OMLYCLO | 75MG/0.5ML; 150MG/ML; 300MG/2ML | injectable · injection | CELLTRION INC | Prescription | 7 Mar 2025 |
EMA European Union — centrally authorised medicines
Xolair Novartis Europharm Limited · Authorised · authorised 25 Oct 2005 · ATC R03DX05
Therapeutic indication (EMA)
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.
Omlyclo Celltrion Healthcare Hungary Kft. · Authorised · authorised 16 May 2024 · ATC R03DX05
Therapeutic indication (EMA)
Allergic asthma Omlyclo is indicated in adults, adolescents and children (6 to <12 years of age). Omlyclo 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) 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. 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. Chronic rhinosinusitis with nasal polyps (CRSwNP) Omlyclo 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) Omlyclo 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.
Adcomfo Advanz Pharma Limited · Opinion · ATC R03DX05
Therapeutic indication (EMA)
Treatment of asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic spontaneous urticaria (CSU)
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| OMLYCLO | 02553805 | 75 MG / 0.5 ML | SOLUTION · SUBCUTANEOUS | CELLTRION INC. |
| OMLYCLO | 02553813 | 150 MG / 1 ML | SOLUTION · SUBCUTANEOUS | CELLTRION INC. |
| OMLYCLO | 02561018 | 75 MG / 0.5 ML | SOLUTION · SUBCUTANEOUS | CELLTRION INC. |
| OMLYCLO | 02561026 | 150 MG / 1 ML | SOLUTION · SUBCUTANEOUS | CELLTRION INC. |
| XOLAIR | 02260565 | 150 MG / VIAL | POWDER FOR SOLUTION · SUBCUTANEOUS | NOVARTIS PHARMACEUTICALS CANADA INC |
| XOLAIR | 02459787 | 75 MG / 0.5 ML | SOLUTION · SUBCUTANEOUS | NOVARTIS PHARMACEUTICALS CANADA INC |
| XOLAIR | 02459795 | 150 MG / 1 ML | SOLUTION · SUBCUTANEOUS | NOVARTIS PHARMACEUTICALS CANADA INC |
| XOLAIR | 02545136 | 75 MG / 0.5 ML | SOLUTION · SUBCUTANEOUS | NOVARTIS PHARMACEUTICALS CANADA INC |
| XOLAIR | 02545144 | 150 MG / 1 ML | SOLUTION · SUBCUTANEOUS | NOVARTIS PHARMACEUTICALS CANADA INC |
| XOLAIR | 02545160 | 300 MG / 2 ML | SOLUTION · SUBCUTANEOUS | NOVARTIS PHARMACEUTICALS CANADA INC |
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.