XOTERNA

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

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 more 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 more about Glycopyrronium

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

ATC Group		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)
EE	Ravimiamet	1626599, 1626601, 1626612, 1626623, 1626634, 1626645, 1710256
ES	Centro de información online de medicamentos de la AEMPS	113863003
IT	Agenzia del Farmaco	043033012, 043033024, 043033036, 043033048, 043033051, 043033063, 043033075, 043033087
LT	Valstybinė vaistų kontrolės tarnyba	1071507, 1071508, 1071509, 1071510, 1071511, 1071512, 1080636, 1080637
NL	Z-Index G-Standaard	16160266
NL	Z-Index G-Standaard, PRK	107506
PL	Rejestru Produktów Leczniczych	100313500
ZA	Health Products Regulatory Authority	48/10.2.1/0183