Regulatory PathRegulatory requirements compared

Active substances

Glycopyrronium + Indacaterol

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
UTIBRON NEOHALER15.6MCG/INH;27.5MCG/INHpowder · inhalationNOVARTISDiscontinued29 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)

BrandDINStrengthForm · routeCompany
ULTIBRO BREEZHALER02418282110 MCG; 50 MCGCAPSULE · INHALATIONNOVARTIS PHARMACEUTICALS CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffIndacaterol 85micrograms/dose / Glycopyrronium bromide 54micrograms/dose inhalation powder capsules with device£32.5030 capsule1 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.

Components

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.