XOTERNA

This brand name is authorized in Austria, Estonia, Spain, Ireland, Lithuania, Netherlands, Poland, South Africa

Active ingredients

The drug XOTERNA 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 UNII H4S7L81L98 - CHLOROGLYCOPYRRONIUM BROMIDE

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

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
XOTERNA BREEZHALER Inhalation powder, hard capsule	European Medicines Agency (EU)	MPI, EU: SmPC

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: EE	Ravimiamet	Identifier(s): 1626599, 1626601, 1626612, 1626623, 1626634, 1626645, 1710256
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 113863003
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1071507, 1071508, 1071509, 1071510, 1071511, 1071512, 1080636, 1080637
Country: NL	Z-Index G-Standaard	Identifier(s): 16160266
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 107506
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100313500
Country: ZA	Health Products Regulatory Authority	Identifier(s): 48/10.2.1/0183