US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
| UTIBRON NEOHALER | 15.6MCG/INH;27.5MCG/INH | powder · inhalation | NOVARTIS | Discontinued | 29 Oct 2015 |
EMA European Union — centrally authorised medicines
Xoterna Breezhaler Novartis Europharm Limited · Authorised · authorised 18 Sep 2013 · ATC R03AL04
Therapeutic indication (EMA)
Xoterna Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Ultibro Breezhaler Novartis Europharm Limited · Authorised · authorised 19 Sep 2013 · ATC R03AL04
Therapeutic indication (EMA)
Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Ulunar Breezhaler Novartis Europharm Limited · Authorised · authorised 23 Apr 2014 · ATC R03AL04
Therapeutic indication (EMA)
Ulunar Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
| ULTIBRO BREEZHALER | 02418282 | 110 MCG; 50 MCG | CAPSULE · INHALATION | NOVARTIS PHARMACEUTICALS CANADA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
| NHS Drug Tariff | Indacaterol 85micrograms/dose / Glycopyrronium bromide 54micrograms/dose inhalation powder capsules with device | £32.50 | 30 capsule | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
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.