US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| EXDENSUR | 100MG | injection | GLAXOSMITHKLINE LLC | Prescription | 16 Dec 2025 |
EMA European Union — centrally authorised medicines
Exdensur GlaxoSmithKline Trading Services Limited · Authorised · authorised 12 Feb 2026 · ATC R03DX12
Therapeutic indication (EMA)
Asthma Exdensur is indicated as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high dose inhaled corticosteroids (ICS) plus another asthma controller (see section 5.1). Chronic rhinosinusitis with nasal polyps (CRSwNP) Exdensur is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| EXDENSUR | 02568926 | 100 MG / 1 ML | SOLUTION · SUBCUTANEOUS | GLAXOSMITHKLINE INC |
| EXDENSUR | 02568934 | 100 MG / 1 ML | SOLUTION · SUBCUTANEOUS | GLAXOSMITHKLINE 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.