ULTIBRO

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, South Africa

Active ingredients

The drug ULTIBRO contains a combination of these active pharmaceutical ingredients (APIs):

1 Indacaterol UNII 2JEC1ITX7R - INDACATEROL MALEATE

Indacaterol is a partial agonist at the human beta2-adrenergic receptor with nanomolar potency. When inhaled, indacaterol acts locally in the lung as a bronchodilator. In isolated human bronchus, indacaterol has a rapid onset of action and a long duration of action. Read about Indacaterol

2 Glycopyrronium bromide UNII V92SO9WP2I - GLYCOPYRROLATE

Glycopyrronium is an inhaled long-acting muscarinic receptor antagonist (anticholinergic) for once-daily maintenance bronchodilator treatment of COPD. Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways. Read about Glycopyrronium

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
R03AL04	Indacaterol and glycopyrronium bromide	R Respiratory system → R03 Drugs for obstructive airway diseases → R03A Adrenergics, inhalants → R03AL Adrenergics in combination with anticholinergics
Discover more medicines within R03AL04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 526516050086605, 526516050086705
Country: CA	Health Products and Food Branch	Identifier(s): 02418282
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 257-MEE-0414, 5331-MEE-0720
Country: EE	Ravimiamet	Identifier(s): 1626533, 1626544, 1626555, 1626566, 1626577, 1626588, 1747571
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 113862003
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 169596, 473807
Country: FR	Base de données publique des médicaments	Identifier(s): 62553246
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 280074, 335704
Country: HK	Department of Health Drug Office	Identifier(s): 63009, 66270
Country: IE	Health Products Regulatory Authority	Identifier(s): 37690
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7421
Country: IT	Agenzia del Farmaco	Identifier(s): 043031018, 043031020, 043031032, 043031044, 043031057, 043031069, 043031071, 043031083
Country: JP	医薬品医療機器総合機構	Identifier(s): 2259805G1027
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1071501, 1071502, 1071503, 1071504, 1071505, 1071506, 1080632, 1080633
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 076M2014
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 107506
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 16633
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100302590
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64767001
Country: SG	Health Sciences Authority	Identifier(s): 14539P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 20833061
Country: ZA	Health Products Regulatory Authority	Identifier(s): 47/10.2.1/1183