Indacaterol, Glycopyrronium

Xoterna Breezhaler 85 Microgramos/ 43 Microgramos Polvo Para Inhalcion (Capsula Dura)

0,143 mg + 0,063 mg polvo para inhalación (cápsula dura)SpainAuthorisedAuthorised 7 Feb 2019

In other countries

The same active substances on other registers, the same brand first.

Xoterna BreezhalerEuropean Union · Novartis Europharm LimitedSame brand
Xoterna BreezhalerItaly · Polvere per inalazione, capsula rigida · Novartis Europharm LimitedSame brand
Ultibro BreezhalerNew Zealand · Powder for Inhalation 50 mcg with indacaterol 110 mcgSame form
ULTIBRO BREEZHALER 85 micrograme/43 microgrameRomania · 85mcg/43mcg · caps. cu pulb. inhal. · Novartis Europharm LTDSame form
ULTIBRO BREEZHALER 85 micrograme/43 microgrameRomania · 85micrograme/43micrograme · caps. cu pulb. de inhal. · Novartis Europharm LimitedSame form
Ultibro®Breezhaler®Serbia · 85mcg+43mcg · prašak za inhalaciju, tvrda kapsula · PredstavniŠTvo Novartis Pharma Services INC. Beograd (Novi Beograd)Same form

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Indacaterol, Glycopyrronium

Xoterna Breezhaler 85 Microgramos/ 43 Microgramos Polvo Para Inhalcion (Capsula Dura)

0,143 mg + 0,063 mg polvo para inhalación (cápsula dura)SpainAuthorisedAuthorised 7 Feb 2019

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Ultibro®Breezhaler®Serbia · 85mcg+43mcg · prašak za inhalaciju, tvrda kapsula · PredstavniŠTvo Novartis Pharma Services INC. Beograd (Novi Beograd)

Ultibro BreezhalerCanada · 50 MCG + 110 MCG · Capsule · Novartis Pharmaceuticals Canada INC

Ultibro BreezhalerEuropean Union · Novartis Europharm Limited

Ulunar BreezhalerEuropean Union · Novartis Europharm Limited

DilabroItaly · Polvere per inalazione, capsula rigida · S.F. Group S.R.L.

GlindesiaItaly · Polvere per inalazione, capsula rigida · Genetic S.P.A.

ULTIBRO BreezhalerSaudi Arabia · Novartis

Ultibro Breezhaler Inhalation Powder Hard Capsule 110/50 MCGSingapore · 50 mcg + 110 mcg · capsule · Novartis (Singapore) Pte LTD

Utibron NeohalerUnited States · 15.6MCG/INH; 27.5MCG/INH · powder · Novartis

Packs

Pack	Code	Status
XOTERNA BREEZHALER 85 MICROGRAMOS/ 43 MICROGRAMOS POLVO PARA INHALCION (CAPSULA DURA) 30 cápsulas + 1 Inhalador	724744

Documents

The official texts, at the regulator.

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substances: Indacaterol, Glycopyrronium
Strength: 0,143 mg + 0,063 mg
Dosage form: polvo para inhalación (cápsula dura)
Route: vía inhalatoria
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 7 Feb 2019
Registration: 13863003IP1
Marketing authorisation holder: Novartis Europharm Limited
Procedure: EU centralised
Supply: Medicamento Sujeto A Prescripción Médica

Indacaterol + Glycopyrronium · 0,143 mg + 0,063 mg · polvo para inhalación (cápsula dura)

Spain

Xoterna Breezhaler 85 Microgramos/43 Microgramos Polvo Para Inhalacion (Capsula Dura)Indacaterol + Glycopyrronium · 0,143 mg + 0,063 mg · polvo para inhalación (cápsula dura)Spain

Poupox 85 Microgramos/43 Mocrogramos Polvo Para Inhalacion (Capsula Dura)Indacaterol + Glycopyrronium · 143 µg + 63 µg · polvo para inhalación (cápsula dura)Spain

Ultibro Breezhaler 85 Microgramos/43 Microgramos Polvo Para Inhalacion (Capsula Dura)Indacaterol + Glycopyrronium · 0,143 mg + 0,063 mg · polvo para inhalación (cápsula dura)Spain

Xoterna Breezhaler 85 Microgramos/43 Microgramos Polvo Para Inhalacion (Capsula Dura)Indacaterol + Glycopyrronium · 0,143 mg + 0,063 mg · polvo para inhalación (cápsula dura)Spain